Incidence rate of community-acquired pneumonia in adults: a population-based prospective active surveillance study in three cities in South America.

OBJECTIVE: To determine the incidence rate and mortality of community-acquired pneumonia (CAP) in adults in three cities in Latin America during a 3-year period. DESIGN: Prospective population-based surveillance study. SETTING: Healthcare facilities (outpatient centres and hospitals) in the cities of General Roca (Argentina), Rivera (Uruguay) and Concepción (Paraguay). PARTICIPANTS: 2302 adults aged 18 years and older with CAP were prospectively enrolled between January 2012 and March 2015. MAIN OUTCOME MEASURES: Incidence rates of CAP in adults, predisposing conditions for disease, mortality at 14 days and at 1 year were estimated. Incidence rate of CAP, within each age group, was calculated by dividing the number of cases by the person-years of disease-free exposure time based on the last census; incidence rates were expressed per 1000 person-years. RESULTS: Median age of participants was 66 years, 46.44% were men, 68% were hospitalised. Annual incidence rate was 7.03 (95% CI 6.64 to 7.44) per 1000 person-years in General Roca, 6.33 (95% CI 5.92 to 6.78) per 1000 person-years in Rivera and 1.76 (95% CI 1.55 to 2.00) per 1000 person-years in Concepción. Incidence rates were highest in participants aged over 65 years. 82.4% had at least one predisposing condition and 48% had two or more (multimorbidity). Chronic heart disease (43.6%) and smoking (37.3%) were the most common risk factors. 14-day mortality rate was 12.1% and 1-year mortality was 24.9%. Multimorbidity was associated with an increased risk of death at 14 days (OR 2.91; 95% CI 2.23 to 3.80) and at 1 year (OR 3.00; 95% CI 2.44 to 3.70). CONCLUSIONS: We found a high incidence rate of CAP in adults, ranging from 1.76 to 7.03 per 1000 person-years, in three cities in South America, disclosing the high burden of disease in the region. Efforts to improve prevention strategies are needed.

Osteomielitis por mucorales (OMM) asociada a artroscopia de reparación de ligamento cruzado anterior: investigación epidemiológica y recomendaciones para su prevención / Mucor osteomyelitis after arthroscopic repair of ACL. Epidemiological investigation

OBJETIVO: Describir la investigación epidemiológica de osteomielitis por Mucorales (OMM) post reparación artroscópica de LCA (RA-LCA) en Argentina. MATERIAL Y MÉTODO: 1) Revisión de los casos; 2) Relevamiento de 3 instituciones; 3) Cultivo micológico de materiales quirúrgicos; 4) Encuesta a instrumentadoras; 5) Secuenciación de las cepas de Rhizopus y 6) Redacción de recomendaciones. RESULTADOS: Del 2005 al 2017 se identificaron 40 casos de OMM (Rhizopus sp.) post reparación artroscópica de LCA en pacientes inmunocompetentes de 12 jurisdicciones de Argentina. El diagnóstico fue por cultivo (22/31), y por anatomía patológica (9). La edad promedio fue 29 años. El 84% de 38 casos eran varones. Intervinieron 13 ortopedias. El implante fue importado en 8/20 casos y nacional en 12. En las 3 instituciones se observó: manejo inadecuado del aire de quirófano, variabilidad en la limpieza del artroscopio, en el taladro utilizado, y en el manejo de materiales que llegan de las ortopedias y falta de trazabilidad de los implantes. Los cultivos micológicos de los materiales fueron negativos. La encuesta a instrumentadores confirmó los hallazgos de los relevamientos. La secuenciación de las cepas de Rhizopus demostró predominio de policlonalidad. CONCLUSIÓN: La OMM es una complicación posible luego de la RA-LCA en instituciones privadas de Argentina. No se identificó un origen único. Se detectaron múltiples prácticas que favorecen la contaminación de la cirugía con hongos filamentosos (manejo del aire de quirófano, del artroscopio, de los materiales provenientes de ortopedia, etc.). En base a estos hallazgos la Asociación Argentina de Artroscopía sugiere medidas de prevención. Implicancia clínica: Prevención de osteomielitis por Mucorales post- cirugía artroscópica para ligamento cruzado anterior. Tipo de estudio: Serie de casos. Nivel de Evidencia: IV.

OBJECTIVE: To describe the epidemiological investigation of Mucor osteomyelitis (MO) after arthroscopic repair of ACL (ARACL) in Argentina. MATERIAL Y METHODS: 1) Review of cases; 2) Survey of 3 institutions; 3) Mycological culture of surgical materials; 4) Survey of instrumentists; 5) Sequencing of Rhizopus strains and 6) Writing of recommendations. RESULTS: From 2005 to 2017, 40 cases of MO (Rhizopus sp.) Post AR-ACL were identified in immunocompetent patients from 12 jurisdictions of Argentina. The diagnosis was made by culture (22/31), and by pathology (9). The average age was 29 years. 84% of 38 cases were male. Thirteen orthopedics intervened. The implant was imported in 8/20 cases and national in 12. In the 3 institutions it was observed: inadequate handling of the operating room air, variability in the cleaning of the arthroscope, in the drill used, and in the handling of materials that come from the orthopedics and lack of traceability of the implants. The mycological cultures of the materials were negative. The survey of instrumentists confirmed the findings of the surveys. The sequencing of Rhizopus strains showed a predominance of polyclonality. CONCLUSION: MO is a possible complication after AR-ACL in private institutions in Argentina. A unique origin was not identified. Multiple practices that favor the contamination of surgery with filamentous fungi (handling of operating room air, arthroscope, materials from orthopedics, etc.) were detected. Based on these findings, the Argentine Association of Arthroscopy suggests prevention measures. Clinical relevance: Prevention of Mucor osteomyelitis after arthroscopic surgery for anterior cruciate ligament. Type study: Cases series. Level of evidence: IV.

Long term mortality in burned children.

Studies about risk factors for mortality in burn children are scarce and are even less in the follow up of this population across time. Usually, after complete event attendance, children are not follow-up as risk patients, burn injury affects all facets of life. Integration of professionals from different disciplines has enabled burn centers to develop collaborative methods of assessing the quality of care delivered to patients with burns. In this editorial we comment the paper of Duke et al. The authors highlight the importance of maintaining a long-term monitoring of children who suffered burns. The importance of this original study is to promote the reconsideration of clinical guides of long-term follow-up of burn patients.

Descripción epidemiológica de los episodios de sífilis asistidos en una institución de la Ciudad de Buenos Aires durante el período 2008-2011 / Epidemiological description of episodes of syphilis attending an institution of the city of Buenos Aires during the period 2008-2011

Introducción: se han notificado epidemias de sífilis en di-versas regiones del mundo, la reemergencia de sífilis constituye un problema de salud pública.Objetivos: determinar número de casos de sífilis diagnosticados y asistidos en una institución, analizar características demográficas, pertenencia o no a la población vulnerable de hombres que tienen sexo con hombres (HSH), estadio del episodio en el momento del diagnóstico, coinfección con infección por VIH, estadios clínicos en VIH reactivos y no reactivos. Materiales y métodos: en la base de datos del laboratorio se iden-tificaron VDRL ≥ 1/8 de pacientes mayores de 18 años asistidos en la institución durante 2008-2011. En forma retrospectiva se revisa-ron las historias clínicas de los pacientes con diagnóstico de sífilis. Resultados: se diagnosticaron 356 episodios en 325 pacientes. Edad media 38,6 años(DS 10,47), mediana 37 años, 95,3 % hombres, 65,2 % VIH reactivos; 50,5 % fueron sífilis primaria o secun-daria y 45 % sífilis latente. Estadio de sífilis similar en pacientes VIH reacti-vos y no reactivos (p = 0,41). Se analizó el número total de VDRL procesadas y el porcentaje de posi-tividad de las mismas en los cuatro años estudiados. Se observó aumento de la tasa anual de positividad de VDRL por 1000 VDRL solicitadas, diferencia estadísticamente no significa-tiva (p = 0,1).Discusión: los episodios de sífilis fueron diagnosticados predomi-nantemente en hombres, en HSH y en pacientes VIH reactivos. Los resultados de nuestro estudio sugieren que la implementación ru-tinaria del testeo para sífilis en poblaciones vulnerables permite diagnosticar un número considerable de episodios en pacientes sin-tomáticos y asintomáticos, ofreciendo beneficios clínicos y epide-miológicos.

Introduction: syphilis epidemics have been reported worldwide and currently represent a major reemerging public health problem.Objectives: to determine the number of cases of syphilis diagnosed at one institution, analyzing demographics, subjects belonging to the population of men who have sex with men (MSM), stage of the episode at the time of diagnosis, co infection with HIV infection, clinical stages in HIV reactive and non-reactive patients. Materials and methods: in the database laboratory VDRL ≥ 1/8 of patients over 18 years attended the institution during 2008-2011 were identified. We retrospectively reviewed the medical records of patients with diagnosis of syphilis Results: 356 episodes were diagnosed in 325 patients. Mean age 38.6 years; median age 37 years; 95.3% male, 65.2% HIV reactive; 50.5% were primary or secondary syphilis and 45% latent syphilis. Similar stage syphilis in HIV reactive and non-reactive (p = 0.41). Increase in the annual rate of positive VDRL requested by 1000 VDRL was observed, however, the difference was no statistically significant (p = 0.1).Discussion: episodes of syphilis were diagnosed predominantly in men, MSM and HIV reactive patients. The results of our study suggest that implementation of routine testing for syphilis in vulnerable populations to diagnose symptomatic and asymptomatic syphilis may provide clinical benefits and epidemiological.

Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers.

OBJECTIVES: This phase III study assessed the safety and immunogenicity of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, administered with routine vaccines starting at 2 months of age. METHODS: Healthy infants received MenACWY-CRM in a two- or three-dose primary infant series plus a single toddler dose. In addition, a two-dose toddler catch-up series was evaluated. Immune responses to MenACWY-CRM were assessed for serum bactericidal activity with human complement (hSBA). Reactogenicity and safety results were collected systematically. RESULTS: After a full infant/toddler series or two-dose toddler catch-up series, MenACWY-CRM elicited immune responses against the four serogroups in 94-100% of subjects. Noninferiority of the two- versus three-dose MenACWY-CRM infant dosing regimen was established for geometric mean titers for all serogroups. Following the three-dose infant primary series, 89-98% of subjects achieved an hSBA ≥ 8 across all serogroups. Immune responses to concomitant routine vaccines given with MenACWY-CRM were noninferior to responses to routine vaccines alone, except for pertactin after the two-dose infant series. Noninferiority criteria were met for all concomitant antigens after the three-dose infant series. CONCLUSIONS: MenACWY-CRM vaccination regimens in infants and toddlers were immunogenic and well tolerated. No clinically meaningful effects of concomitant administration with routine infant and toddler vaccines were observed.

Risk factors for mortality in burn children

Studies about risk factors for mortality in burn children are scarce. We conducted this study to evaluate the risk factors for mortality in pediatric burn patients. We included 110 patients. Mean age was 31.5 months (range: 1 to 204). The burn surface was between 1% and 95%(median 27%) Type of burn was: A or superfitial in 39 patients (36%), AB or intermediate in 19 (17%), and B or full thickness in 52 (47%). Inhalatory injury was present in 52 patients (47%). Invasive procedures were: venous catheter, 90 patients (82%), arterial catheter, 83patients (75.5%), urinary catheter, 86 patients (78%), and mechanical ventilation, 75 patients (68%). In 84 patients, 128 infections were diagnosed. in 53 cases (48%). Multiresistant Pseudomonas aeruginosa and Acynetobacter baumannii were the most common organisms isolated. The median length of hospital stay was 33 days (r: 8-139 days). Seventeen patients (15%) died and 14 of them of infection-related causes. Age< <4 years, Garcés 4, full thickness burn, > 40% burn surface, presence of inhalatory syndrome, use of venous catheter, arterial catheter, urinary catheter and mechanical ventilation, positive blood cultures, colistin use in documented multiresistant infections, antifungal use and graft requirement, were identified as risks factors for mortality in the univariate analysis. By multivariate analysis: age <4 years, Garcés 4, colistin use in multiresistant infections, mechanical ventilation and graft requirement were independent variables related with mortality. CONCLUSIONS: In this series of burn children age < 4 years, Garces index score 4, colistin use in documented multiresistant infections, mechanical ventilation and graft requirement were identified as independent variables related with mortality. .

Risk factors for mortality in burn children.

UNLABELLED: Studies about risk factors for mortality in burn children are scarce. We conducted this study to evaluate the risk factors for mortality in pediatric burn patients. We included 110 patients. Mean age was 31.5 months (range: 1 to 204). The burn surface was between 1% and 95%(median 27%) Type of burn was: A or superfitial in 39 patients (36%), AB or intermediate in 19 (17%), and B or full thickness in 52 (47%). Inhalatory injury was present in 52 patients (47%). Invasive procedures were: venous catheter, 90 patients (82%), arterial catheter, 83 patients (75.5%), urinary catheter, 86 patients (78%), and mechanical ventilation, 75 patients (68%). In 84 patients, 128 infections were diagnosed. in 53 cases (48%). Multiresistant Pseudomonas aeruginosa and Acynetobacter baumannii were the most common organisms isolated. The median length of hospital stay was 33 days (r: 8-139 days). Seventeen patients (15%) died and 14 of them of infection-related causes. Age ≤ <4 years, Garcés 4, full thickness burn, ≥ 40% burn surface, presence of inhalatory syndrome, use of venous catheter, arterial catheter, urinary catheter and mechanical ventilation, positive blood cultures, colistin use in documented multiresistant infections, antifungal use and graft requirement, were identified as risks factors for mortality in the univariate analysis. By multivariate analysis: age ≤ 4 years, Garcés 4, colistin use in multiresistant infections, mechanical ventilation and graft requirement were independent variables related with mortality. CONCLUSIONS: In this series of burn children age ≤ 4 years, Garces index score 4, colistin use in documented multiresistant infections, mechanical ventilation and graft requirement were identified as independent variables related with mortality.

Infections in burned children: epidemiological analysis and risk factors.

INTRODUCTION: Burns are the third cause of accidental deaths among children. Approximately 50-60% of these deaths are the result of an infection. OBJECTIVE: To determine infection related risk factors in burned children. POPULATION AND METHODS: All patients admitted to the Burn Unit of Hospital "Prof. Dr. Juan P. Garrahan" between June 2007 and December 2009 were included. The epidemiology of hospital-acquired infections and the associated outcome measures were determined. Groups of infected and non-infected children were compared using Student's t test or the Mann-Whitney Rank Sum test, as applicable. Dichotomous outcome measures were analyzed with the X2 test using Yates' correction. In order to assess the predictive value of independent outcome measures, the multiple logistic regression model was applied. RESULTS: In this cohort of 110 children, 128 hospital-acquired infections were recorded in 84 patients. There were 17 deaths (15%); 14 out of these 17 (82%) were related to infection. Infection-related factors included the percentage of burned body surface area; the highest Garces' index; burn depth; antibiotic prophylaxis; the use of topical antibiotics; the presence of a central venous line, an arterial line, a urinary catheter, mechanical ventilation support, escharotomy, and the need of a graft. The multivariate analysis showed a higher risk of infection with the use of central venous lines (RR: 5.15; 95% CI: 1.44-18.46), antibiotic prophylaxis (RR: 5.22; 95% CI: 1.26-21.63), and graft requirement (RR: 3.65; 95% CI: 1.08-12.37). CONCLUSIONS: The presence of lines or catheters, antibiotic prophylaxis, and graft requirement were independent risk factors for infection in burned children.

Infecciones en los niños quemados: análisis epidemiológico y de los factores de riesgo / Infections in burned children: epidemiological analysis and risk factors

Introducción. Las quemaduras son la tercera causa de muerte por accidentes en los niños. El 50 a 60% de estas muertes son por infección. Objetivo. Determinar los factores de riesgo asociados a la infección en los niños quemados. Población y métodos. Se incluyeron todos los pacientes ingresados por quemaduras en la Unidad de Quemados del Hospital "Prof. Dr. Juan P. Garrahan" en el período comprendido entre junio de 2007 y diciembre de 2009. Se determinó la epidemiología de las infecciones intrahospitalarias y las variables asociadas. Se compararon los grupos de niños infectados y no infectados con las pruebas de Student o de Mann-Whitney Rank Sum, según correspondía. Las variables dicotómicas se analizaron con la prueba de la X², con corrección de Yates. Para evaluar el valor predictivo de las variables independientes se utilizó el modelo de regresión logística múltiple. Resultados. En esta cohorte de 110 niños se documentaron 128 infecciones intrahospitalarias en 84 pacientes. Se produjeron 17 (15%) muertes; en 14 de 17 (82%) la causa estuvo relacionada con la infección. Los factores vinculados a la infección fueron el porcentaje de superfcie quemada; el mayor puntaje de Garcés; la profundidad de la quemadura; la proflaxis antibiótica; el uso de antibióticos tópicos; la presencia de catéter venoso central, catéter arterial, sonda vesical, asistencia respiratoria, escarectomía y requerimiento de injerto. El análisis multivariado mostró mayor riesgo de infección con el uso de catéteres venosos centrales (RR 5,15; IC 95% 1,44 a 18,46), la proflaxis antibiótica (RR 5,22; IC 95% 1,26 a 21,63) y el requerimiento de injerto (RR 3,65; IC 95%; 1,08 a 12,37). Conclusiones. La presencia de catéteres, la proflaxis antibiótica y el requerimiento de injerto fueron factores independientes de riesgo de infección en los niños quemados.

Introduction. Burns are the third cause of accidental deaths among children. Approximately 50-60% of these deaths are the result of an infection. Objective. To determine infection related risk factors in burned children. Population and Methods. All patients admitted to the Burn Unit of Hospital "Prof. Dr. Juan P. Garrahan" between June 2007 and December 2009 were included. The epidemiology of hospital-acquired infections and the associated outcome measures were determined. Groups of infected and non-infected children were compared using Student's t test or the Mann-Whitney Rank Sum test, as applicable. Dichotomous outcome measures were analyzed with the X2 test using Yates' correction. In order to assess the predictive value of independent outcome measures, the multiple logistic regression model was applied. Results. In this cohort of 110 children, 128 hospital-acquired infections were recorded in 84 patients. There were 17 deaths (15%); 14 out of these 17 (82%) were related to infection. Infection-related factors included the percentage of burned body surface area; the highest Garces' index; burn depth; antibiotic prophylaxis; the use of topical antibiotics; the presence of a central venous line, an arterial line, a urinary catheter, mechanical ventilation support, escharotomy, and the need of a graft. The multivariate analysis showed a higher risk of infection with the use of central venous lines (RR: 5.15; 95% CI: 1.44-18.46), antibiotic prophylaxis (RR: 5.22; 95% CI: 1.26-21.63), and graft requirement (RR: 3.65; 95% CI: 1.08-12.37). Conclusions. The presence of lines or catheters, antibiotic prophylaxis, and graft requirement were independent risk factors for infection in burned children.

Estudio prospectivo de infecciones en niños quemados / Aprospective study on infections in children with burn injuries

Las infecciones juegan un rol importante en la morbilidad y mortalidad asociada a quemaduras. La experiencia en pacientes pediátricos es escasa. Se llevo a cabo este estudio con el objetivo de evaluar las características epidemiológicas, clínicas, microbiológicas y de evolución de niños quemados. Material y métodos: cohorte prospectiva de niños quemados admitidos entre junio de 2007 y diciembre de 2009 en el Hospital de Pediatría Garrahan-Argentina. Resultados: el total de pacientes fue de 110, con una mediana de edad de 31.5 meses. El porcentaje de superficie corporal quemada tuvo un rango de 1 a 95%. El tipo de quemadura fue A en 39 pacientes, AB en 19 y B en 52. Noventa pacientes tuvieron catéter venoso, 83 catéter arterial y 86 sonda vesical. En 75 pacientes se requirió asistencia ventilatoria mecánica, en 84 pacientes se documentaron 128 infecciones. El foco más frecuente fue la sepsis relacionada con la quemadura. Las bacterias gram negativas Pseudomonas aeruginosa y Acinetobacter spp multirresistentes, fueron los gérmenes mas frecuentemente aislados. Se fueron de alta 93 pacientes y 17 fallecieron. En 14 de ellos la causa del fallecimiento estuvo relacionada con la infección. La duración de la internación tuvo una mediana de 37 días. Conclusiones: las infecciones en niños quemados son una importante causa de morbimortalidad y las bacterias gram negativas multirresistentes juegan un importante rol en las mismas. La mortalidad estuvo relacionada con la infección.

Infections play an important role in burns-associated morbid-ity and mortality. Experience in pediatric patients is scarce. A study was conducted with the aim to assess epidemiological, clinical, and microbiological features and outcome in children with burn injury. Material and Methods: A prospective cohort of children with burn injuries admitted to the pediatric hospital J P Garrahan, Argentina, between June 2007 and December 2009. Results: A total number of 110 patients with a median age of 31.5 months was enrolled in the study. The percentage of burned body surface ranged from 1 to 95% (median 27%). Types of burns were A (superficial) in 39 patients (36%), AB (intermediate) in 19 (17%) and B (deep) in 52 (47%). Ninety patients (82%) had an intravenous catheter, 83 (75.5%) an arterial catheter, and 86 (78%) a urinary catheter. Seventy-five patients (68%) required mechanical ventilation. In 84 patients, 128 infections were registered. The most-frequently found focus was burn-associated sepsis. Multiresistent gram-neg-ative bacteria Pseudomonas aeruginosa and Acinetobacter spp were the most-frequently isolated germs. Ninety-three patients (85%) were discharged and 17 (15%) died. In 14 (82%) of the latter patients the cause of death was related to the infection. Median hospital stay was 37 days (r: 1 - 139). Conclusions: In children with burn injuries, infections are an important cause of morbidity and mortality and multiresistent gram-negative bacteria are often associated. Mortality was related to the infection.

Systematic review: which topical agent is more efficacious in the prevention of infections in burn patients?

Topical agents are widely used in the care of burn patients; however the efficacy to prevent local infections and/or sepsis has not been clearly established in studies with a high level of evidence. This systematic review was conducted to assess the comparative efficacy among different topical agents. Material and Methods. The literature search was performed using the Medline database. Key MESH terms were: (burn* or scald*) AND (antibacterial or antibiotic*) AND (topic*) AND (therap* or prophylax*). Only randomized or quasi-randomized clinical trials, with a primary endpoint of local infection and/or sepsis were included. Studies were scored and classified regarding methodological key issues according to their level of evidence. Results. The initial search identified 457 studies of which 14 were eligible for final evaluation, and full text was available for 11 of them. Conclusions. The evidence found in our review does not support differences in efficacy of topical agents to reduce sepsis and/or local infections in burn patients.

Systematic Review: which topical agent is more efficacious in the prevention of infections in burn patients? / Revisión sistemática: ¿Cuál es el agente tópico más eficaz en la prevención de infecciones en el paciente quemado?

Topical agents are widely used in the care of burn patients; however the efficacy to prevent local infections and/or sepsis has not been clearly established in studies with a high level of evidence. This systematic review was conducted to assess the comparative efficacy among different topical agents. Material and Methods. The literature search was performed using the Medline database. Key MESH terms were: (burn* or scald*) AND (antibacterial or antibiotic*) AND (topic*) AND (therap* or prophylax*). Only randomized or quasi-randomized clinical trials, with a primary endpoint of local infection and/or sepsis were included. Studies were scored and classified regarding methodological key issues according to their level of evidence. Results. The initial search identified 457 studies of which 14 were eligible for final evaluation, and full text was available for 11 of them. Conclusions. The evidence found in our review does not support differences in efficacy of topical agents to reduce sepsis and/or local infections in burn patients.

Los agentes tópicos son ampliamente utilizados en el cuidado de los pacientes quemados. Con el objetivo de evaluar la eficacia comparativa entre diferentes agentes tópicos habitualmente utilizados para la prevención de infecciones, llevamos a cabo una revisión sistemática. Material y métodos. La búsqueda bibliográfica se realizó en la base Medline. Las palabras clave utilizadas, fueron: burn* or scald* AND antibacterial or antibiotic* AND topic* AND therap* or prophylax*. Solamente se incluyeron estudios con asignación aleatorizada o cuasi-aleatorizada de las intervenciones y cuya variable principal fuera la presencia de infección local y/o sepsis. Resultados. La búsqueda inicial detectó 457 artículos, de los cuales se seleccionaron 14 para su evaluación final, disponiendo del texto de 11 de ellos. Conclusiones. Las evidencias halladas sobre el tema fueron de calidad científica moderada. No se identificaron evidencias que demostraran la superioridad de alguno de los agentes tópicos sobre otros para reducir la infección o la sepsis en el paciente quemado.

Immunogenicity, safety, and tolerability of two trivalent subunit inactivated influenza vaccines: a phase III, observer-blind, randomized, controlled multicenter study.

The objective of this study was to evaluate and compare the immunogenicity, safety, and tolerability of two influenza subunit vaccines, a primarily European-marketed trivalent vaccine (Agrippal®, Novartis Vaccines), and a predominantly U.S.-marketed control trivalent vaccine (Fluvirin®, Novartis Vaccines), in subjects aged 3-64 y. The immunogenicity of both vaccines was evaluated according to the Center for Biologics Evaluation and Research (CBER) criteria. This clinical trial was performed between April and December 2007 in Argentina. A total of 1893 subjects were stratified into three age groups (3-8 y, 9-17 y, and 18-64 y), and randomized in a 2:1 ratio to receive either Agrippal or Fluvirin. Adolescents and adults received one dose of vaccine intramuscularly, whereas children aged 3-8 years received two vaccine doses, administered 4 wk apart. Antibody levels were measured by means of hemagglutination inhibition assay before vaccination (baseline); 21 d after the first vaccination (adults and adolescents); and, for children aged 3-8 y, 28 d after the first vaccination and 21 d after the second vaccine dose. Adverse reactions were solicited via diary cards for 7 d after each vaccination, and unsolicited adverse events were reported throughout the study period. Both vaccines were safe and well-tolerated, and elicited robust immunogenic responses in all age groups, meeting both CBER licensure criteria for all three viral strains after completion of the age-recommended vaccination schedule. These findings support the use of the trivalent subunit influenza vaccines Agrippal and Fluvirin for universal vaccination campaigns on an annual basis. ClinicalTrials.gov: NCT00464672.

Safety of a second dose of varicella vaccine administered at 4 to 6 years of age in healthy children in Argentina.

Varicela Biken [Live varicella Biken vaccine (strain Oka)] is an effective and safe vaccine for the prevention of varicella infection. Although the recommended schedule in all age groups (children, adolescents and adults) is a single dose, physicians in some countries follow the 2007 recommendation of the US Advisory Committee on Immunization Practices (ACIP) which recommends "implementation of a routine 2-dose varicella vaccination program for children, with the first dose administered at age 12--15 months and the second dose at age 4--6 years." ( 1) Therefore, cases can arise when two doses of Varicela Biken are given even though the ACIP guidelines are a response to the US epidemiological situation and for US licensed products based on the Oka/Merck and the Oka-RIT strains (Varicela Biken is not registered in US). The aim of this study is to ascertain the safety of a second dose of Varicela Biken in children who have been previously vaccinated with the same vaccine. In this study, children, 4-6 years of age who had been previously vaccinated with Varicela Biken, received a single 0.5 mL dose of live attenuated varicella virus vaccine containing at least 1000 Plaque Forming Units (PFU) attenuated live Varicella-zoster virus (Oka strain). Participants were monitored for 30 minutes after vaccination. Predefined injection site and systemic reactions were solicited during the subsequent seven days. Unsolicited injection site reactions and unsolicited systemic events were collected throughout the study. Any serious adverse events occurring throughout the study were reported to the sponsor's pharmacovigilance department. One hundred and twenty two children were recruited and all provided safety data. There were no immediate adverse events or injection site reactions. Forty three percent of participants reported injection site reactions and 22.1% reported systemic reactions on solicitation during the seven days after vaccination. During the 30 day monitoring period, 43 participants reported a total of 66 adverse events. Seven participants reported a total of eight unsolicited events that were assessed as related to the vaccine or where the relationship to vaccination was unknown. Five of these eight events were injection site reactions and all were mild, systemic reactions included mild rash (1 case) and fever (2 cases). There was a single serious adverse event that was not related to the study medication (subject was a passenger in a motor vehicle accident). A second dose of Varicela Biken was well tolerated and showed no significant safety issues in this population of previously vaccinated children.

Acceptance of Intanza® 9 µg intradermal influenza vaccine in routine clinical practice in Australia and Argentina.

INTRODUCTION: Intanza® 9 µg (Sanofi Pasteur SA, Lyon, France), a split virion trivalent influenza vaccine delivered by intradermal injection with a microinjection system, became available as a vaccination for adults aged 18 to 59 years old, as of the 2010 southern hemisphere influenza season. METHODS: This study was designed to assess the acceptability of intradermal vaccination with Intanza 9 µg in routine clinical practice by adult vaccinees and their prescribers. Prescribers and healthy adults 18 to 59 years old in Australia and Argentina who had elected to be vaccinated with Intanza 9 µg during the 2010 southern hemisphere influenza season were recruited to complete surveys about their opinions of influenza vaccination and acceptance of the intradermal vaccination. RESULTS: 1402 vaccinees and 30 prescribers in Australia, and 264 vaccinees and 16 prescribers in Argentina responded to surveys. In both countries, 98% of vaccinees were satisfied or very satisfied with Intanza 9 µg. The main reasons for satisfaction were that the injection was considered minimally painful and that the vaccination was quickly administered. Most (95%) vaccinees reported that they would prefer to receive the same vaccination next year. Furthermore, 85% of prescribers were satisfied or very satisfied with the intradermal vaccine. CONCLUSION: Intradermal vaccination for seasonal influenza using Intanza 9 µg is well accepted both by adult vaccinees and prescribers. By providing an additional, well-accepted method, Intanza 9 µg might help increase seasonal influenza vaccination rates in adults.

[Efficacy of five disinfectants to reduce bacterial load in the household]. / Eficacia de cinco desinfectantes para la reducción bacteriana doméstica.

The proper use of products containing sodium hypochlorite,ammonium salts and triclosan has proved to be effective in the elimination of infectious agents in the household environment. Our objective was to evaluate the immediate, one-week and one-month efficacy of controlled use of five products containing these components, compared to other commonly used products. Within a six month period, thirty two middle-class homes from Buenos Aires City and suburbs were included in this open-label, randomized, parallel-group intervention study. Sixteen homes were randomized to use products containing sodium hypochlorite, ammonia and triclosan in the kitchen and bathroom during one month. The remaining maintained usual practices for domestic cleaning. Bacterial counts and identification were performed from samples taken from each study site. Baseline samples (no group discrimination) contained a mean bacterial count in kitchen of 66.0 CFU/cm2, and in bathroom 40.1 CFU/cm2. Samples taken immediately after-cleaning (no group discrimination) contained: kitchen 0.8 CFU/cm2; bathroom < 1 CFU/cm2. After one week (intervention group vs. control group) contained: kitchen 18.0 vs. 32.5 CFU/cm2; bathroom 12.7 vs. 7.7 CFU/cm2. After one month (intervention group vs. control group): kitchen 60.1 vs. 62.1 CFU/cm2; bathroom 37.0 vs. 42.0 CFU/cm2. A remarkable decrease of bacterial load was observed in both groups, which suggests that not only product quality but also education for suitable use plays a key role in successful house disinfection. This approach could be an important tool for improving prevention of foodborne infections since fecal coliforms widely predominated in all analyzed samples.

Eficacia de cinco desinfectantes para la reducción bacteriana doméstica / Efficacy of five disinfectants to reduce bacterial load in the household

El uso adecuado de hipoclorito de sodio, sales de amonio cuaternario y triclosán ha demostrado ser eficaz para eliminar gérmenes dentro del hogar. Nuestro objetivo fue evaluar la eficacia inmediata, a la semana y al mes del uso controlado de cinco productos con estos componentes, comparados con otros productos de uso habitual. Se incluyeron 32 hogares de clase media de la Ciudad de Buenos Aires y la periferia en un estudio con intervención, abierto, aleatorizado, y de grupos paralelos, durante 6 meses. La mitad de los hogares fue seleccionada para usar hipoclorito de sodio, sales de amonio cuaternario y triclosán en la cocina y el baño durante un mes. El grupo control mantuvo prácticas habituales de limpieza doméstica. Se tomaron muestras para recuento y tipificación bacteriana de los sitios estudiados: muestras basales (sin discriminación de grupo) en cocina, que presentaron recuento bacteriano promedio de 66.0 UFC/cm²; baño: 40.1 UFC/cm². Las muestras inmediatas a la limpieza (sin discriminación de grupo): en cocina: 0.8 UFC/cm²; baño: <1 UFC/cm². A la semana (grupo intervenido vs. grupo control): cocina 18.0 vs. 32.5 UFC/cm²; baño 12.7 vs. 7.7 UFC/cm². Al mes (intervenido vs. control): cocina: 60.1 vs. 62.1 UFC/cm²; baño: 37.0 vs. 42.0 UFC/cm². Se observó una notable disminución de la carga bacteriana en ambos grupos, lo que sugiere que no sólo la calidad de los productos sino también la educación en el uso desempeñan un papel clave en la desinfección del hogar. Este enfoque podría ser una herramienta importante para prevenir infecciones transmitidas por alimentos, dado que los coliformes fecales predominaron ampliamente en todas las muestras tipificadas.

The proper use of products containing sodium hypochlorite, ammonium salts and triclosan has proved to be effective in the elimination of infectious agents in the household environment. Our objective was to evaluate the immediate, one-week and one-month efficacy of controlled use of five products containing these components, compared to other commonly used products. Within a six month period, thirty two middle-class homes from Buenos Aires City and suburbs were included in this open-label, randomized, parallel-group intervention study. Sixteen homes were randomized to use products containing sodium hypochlorite, ammonia and triclosan in the kitchen and bathroom during one month. The remaining maintained usual practices for domestic cleaning. Bacterial counts and identification were performed from samples taken from each study site. Baseline samples (no group discrimination) contained a mean bacterial count in kitchen of 66.0 CFU/cm², and in bathroom 40.1 CFU/cm². Samples taken immediately after-cleaning (no group discrimination) contained: kitchen 0.8 CFU/cm²; bathroom < 1 CFU/ cm². After one week (intervention group vs. control group) contained: kitchen 18.0 vs. 32.5 CFU/cm²; bathroom 12.7 vs. 7.7 CFU/cm². After one month (intervention group vs. control group): kitchen 60.1 vs. 62.1 CFU/cm²; bathroom 37.0 vs. 42.0 CFU/cm². A remarkable dicrease of bacterial load was observed in both groups, which suggests that not only product quality but also education for suitable use plays a key role in successful house disinfection. This approach could be an important tool for improving prevention of foodborne infections since fecal coliforms widely predominated in all analyzed samples.

Reproducción asistida en hombres infectados con el virus de VIH / Assisted reproduction in HIV positive men

Objetivo: Describir un programa de procreación responsable en parejas donde el varón está infectado con el VIH organizado en un centro ambulatorio infectológico de la ciudad de Bs. As. y llevado a cabo por un equipo interdisciplinario conformado por Infectólogos, Bioquímicos, Ginecólogos y Biólogos. Comentar algunas revisiones de la literatura que avalan la evidencia cientifica para realizar estos procedimientos. Métodos: las parejas serodiscordantes son candidatas para este programa si el varón tiene seguimiento infectológico, los estudios de esperma demuestran carga viral (CV) indetectable y DNA proviral de VIH negativo, y, la mujer tiene ADN proviral de VIH negativo en sangre, en el ciclo en el cual se realizará el procedimiento de fertilización asistida. Se realiza en la mujer pesquisa de infecciones connatales. Las muestras de esperma son procesadas con técnicas de lavado, swim up y swim down, y congeladas. Después de cada procedimiento de fertilización asistida la mujer es controlada controlada con estudios serológicos para anticuerpos (VIH ELISA) periódicos. Los recién nacidos son evaluados a través de ADN proviral de VIH en el 1er mes de vida, o, durante los primeros 6 meses de vida a través de anticuerpos (VIH ELISA). Resultadaos: desde 12/2000 y hasta mayo 2009 se incluyeron 165 parejas serodiscordantes. 147 pacientes VIH (+) realizaron estudios de muestras de esperma, 26, tuvieron muestras con estudios microbiológicos positivos (23, CV detectable, y 3, ADN proviral de VIH positivo). En 123 parejas se realizaron: 329 inseminaciones, 55 ICSI y 28 FIV. Se concretron 44 embarazos y nacieron 51 bebés. Todos los estudios realizados a las mujeres y recién nacidos mostraron resultados negativos. Conclusiones: este programa logró resultados satisfactorios en la prevención de infecciones por VIH y connatales.

Objective: to describe the data obtained during the development of an assisted reproduction program for couples where the man is HIV - Infected organized by an ambulatory infectologist center in BsAs city. a multidisciplinary team with infectious disease MD, biochemists, ginecologists and bilogist collaborate in the follow-up of the patients. Methods: couples seeking reproductive counseling were eligible for this programme if: the HIV positive male partner adhered to an infectious disease follow-up, he has undetectable viral load in the fresh sperm sample and is negative for HIV proviral DNA in the swim-up material after sperm washing, the female partner is negative for HIV proviral DNA immediately beforme each assisted reproduction attempt. Procedures comprised intrauterine insemination, intracytoplasmic sperm injection and in vitro fertilization accordin to gynecologist indication. After each procedure, women were tested for indication. After each procedure, women were tested for HIV antibodies periodically. Newborns were tested for HIV proviral DNA at one month of age or HE during the first six months. Results: One hundred and sixty five couples were assessed, semen analyses results were obtained from 147 HIV positive men, 23 had detectable viral load, 3 had positive HIV proviral DNA in swim up. One hundred and twenty three couples undervent AR procedures: 329 intrauterine inseminations, 55 intracytoplasmic sperm injections, and 28 in-vitro fertilizations. Forty four pregnancies resulted in fifty one live Births. All HE and HDP tests performed in women and new-borns were negative. Conclusions: This programme achieved satisfactory results in prevention of HIV and congenital infections.

Indications of a new antibiotic in clinical practice: results of the tigecycline initial use registry.

Tigecycline is the first of a new class of antibiotics named glycylcyclines and it was approved for the treatment of complicated intra-abdominal infections and complicated skin and skin structure infections. Notwithstanding this, tigecycline's pharmacological and microbiological profile which includes multidrug-resistant pathogens encourages physicians' use of the drug in other infections. We analyzed, during the first months after its launch, the tigecycline prescriptions for 113 patients in 12 institutions. Twenty-five patients (22%) received tigecycline for approved indications, and 88 (78%) for "off label" indications (56% with scientific support and 22% with limited or without any scientific support). The most frequent "off label" use was ventilator associated pneumonia (VAP) (63 patients). The etiology of infections was established in 105 patients (93%). MDR-Acinetobacter spp. was the microorganism most frequently isolated (50% of the cases). Overall, attending physicians reported clinical success in 86 of the 113 patients (76%). Our study shows that the "off label" use of tigecycline is frequent, especially in VAP. due to MDR-Acinetobacter spp., where the therapeutic options are limited (eg: colistin). Physicians must evaluate the benefits/risks of using this antibiotic for indications that lack rigorous scientific support.