RESUMO
Lactoferrin (LF) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to determine the effect of bovine lactoferrin (bLF) in the prevention of SARS-CoV-2 infection in health care personnel. A randomized, double-blinded, placebo-controlled clinical trial was conducted in two tertiary hospitals that provide care to patients with SARS-CoV-2 infection in Lima, Peru. Daily supplementation with 600 mg of enteral bLF versus placebo for 90 days was compared. Participants were weekly screened for symptoms suggestive of SARS-CoV-2 infection and molecular testing was performed on suspected episodes. A serological test was obtained from all participants at the end of the intervention. The main outcome included symptomatic and asymptomatic cases. A sub-analysis explored the time to symptomatic infection. Secondary outcomes were the severity, frequency, and duration of symptomatic infection. The study was prematurely cancelled due to the availability of vaccines against SARS-CoV-2 in Peru. 209 participants were enrolled and randomized, 104 received bLF and 105 placebo. SARS-CoV-2 infection occurred in 11 (10.6%) participants assigned to bLF and in 9 (8.6%) participants assigned to placebo without significant differences (Incidence Rate Ratio = 1.23, 95%CI 0.51-3.06, p-value = 0.64). There was no significant effect of bLF on time to symptomatic infection (Hazard Ratio = 1.61, 95%CI 0.62-4.19, p-value = 0.3). There were no significant differences in secondary outcomes. A significant effect of bLF in preventing SARS-CoV-2 infection was not proven. Further studies are needed to assess the effect of bLF supplementation on SARS-CoV-2 infection.Clinical trial registration ClinicalTrials.gov Identifier: NCT04526821, https://clinicaltrials.gov/ct2/show/NCT04526821?term=LACTOFERRIN&cond=COVID-19&cntry=PE&city=Lima&draw=2&rank=1 .
Assuntos
COVID-19 , Lactoferrina , Humanos , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Atenção à Saúde , Hidroxicloroquina/uso terapêutico , Lactoferrina/uso terapêutico , SARS-CoV-2RESUMO
OBJECTIVE: To describe the genotypes of the carbapenemases reported from microbiological isolates of patients in Peru. METHODS: A systematic search of the biomedical literature about carbapenemases with genotypic confirmation was carried out. It included literature published from 1 January 2000 through 15 September 2019 in the PubMed, SCOPUS, Virtual Health Library, CONCYTEC Virtual Library, and Google Scholar databases, and other sources for the publication of abstracts or posters from national or international meetings. Two reviewers carried out the data selection and extraction. RESULTS: Fourteen studies, which carried out the genotypic characterization of 313 carbapenemases, were included. Of the total 313 reports, 103 analyzed enterobacteria: 74 were of Klebsiella pneumoniae, 11 of Proteus mirabilis, 7 of Enterobacter cloacae, and 11 of other enterobacteria; and 61 corresponded to bla NDM , 39 to bla KPC, and 3 to bla IMP . According to their molecular structure, 64 were metallo-ß-lactamases and 39 were serine-ß-lactamases. Of the total reports, 84 analyzed Pseudomonas aeruginosa: 79 corresponded to bla IMP , 4 to bla VIM , and 1 to bla GES. Of the total reports, 126 analyzed Acinetobacter baumannii: 55 corresponded to bla OXA-23 , 66 to bla OXA-24 , 3 to bla NDM, and 2 to bla OXA-143 . CONCLUSIONS: There is a limited number of publications about carbapenemases among patients in Peru. The genotype reports come primarily from hospitals in the country's capital. This is the first review that aims to identify the types of carbapenemases reported in enterobacteria, P. aeruginosa, and A. baummani.
OBJETIVO: Descrever os genótipos das carbapenemases relatadas a partir de isolados microbiológicos de pacientes no Peru. MÉTODOS: Fizemos uma pesquisa sistemática da literatura biomédica publicada de 1º de janeiro de 2000 a 15 de setembro de 2019 nas bases de dados PubMed, SCOPUS, Biblioteca Virtual de Saúde, Biblioteca Virtual CONCYTEC, Google Scholar e outras fontes de publicações de resumos ou pôsteres em conferências nacionais ou internacionais sobre carbapenemases com confirmação genotípica; a seleção e extração de dados foi feita por pares. RESULTADOS: Incluímos 14 estudos nos quais foi feita a caracterização genotípica de 313 carbapenemases. Ao todo, 103 destes relatos vieram de testes efetuados em enterobactérias; destes, 74 foram em Klebsiella pneumoniae, 11 em Proteus mirabilis, 7 em Enterobacter cloacae e 11 em outros organismos. Destes 103 relatos, 61 correspondem a bla NDM, 39 a bla KPC e 3 a bla IMP. Segundo a estrutura molecular, 64 foram metalo-betalactamases e 39 foram serino-betalactamases. Foram incluídos 84 relatos sobre Pseudomonas aeruginosa, dos quais 79 corresponderam a bla IMP, 4 a bla VIM e 1 a bla GES. Também houve 126 relatos sobre Acinetobacter baumannii, dos quais 55 corresponderam a bla OXA-23, 66 a bla OXA-24, 3 a bla NDM e 2 a bla OXA-143. CONCLUSÕES: Existem poucas publicações sobre carbapenemases em pacientes no Peru; os relatos genotípicos provêm, em sua maioria, de hospitais da capital do país. Esta é a primeira revisão que procura estabelecer os tipos de carbapenemases relatadas em enterobactérias, P. aeruginosa e A. baumannii.
RESUMO
OBJECTIVES: To standardize and validate an in-house RT-LAMP test for the detection of SARS-CoV-2, based on laboratory and field assays using samples from COVID-19 suspected patients. MATERIALS AND METHODS: An in-house SARS-CoV-2 RT-LAMP molecular test was standardized, establishing the detection limit with Vero cells of isolated Peruvian strains of SARS-CoV-2, and the robustness to various concentrations of primers. The laboratory validation was performed with 384 nasal and pharyngeal swab samples (UFH) obtained between March and July 2020. The field validation was performed with 383 UFH obtained from COVID-19 suspected symptomatic cases. All samples were tested by RT-LAMP and RT-qPCR. The RT-qPCR was considered as the reference standard test. The concordance measures and diagnostic performance were calculated. RESULTS: The detection limit was consistent in cases with Ct <30 in both tests, showing efficiency to detect up to 1000 copies/µL of the target gene. Robustness was evidenced with half of the primer concentrations and 20 µL of final volume. Absence of amplification was identified for other HCoVs. Concordance showed a kappa index of 0.88 (95% CI: 0.83-0.93) and 0.89 (95% CI: 0.84 - 0.94) in laboratory and field settings, respectively. The sensitivity value in the laboratory was 87.4% (95% CI: 80.8 - 92.4) and 88.1% in the field (95% CI: 81.6 - 92.9). The specificity value in both settings was 98.8% (95% CI: 96.4-99.7). CONCLUSIONS: The in-house SARS-CoV-2 RT-LAMP test was successfully validated based on its adequate robustness, no cross-reactions, good concordance, and diagnostic performance compared to RT-qPCR.
OBJETIVOS: Estandarizar una prueba RT-LAMP in house para la detección de SARS-CoV-2 y validarla con muestras de laboratorio y de campo en pacientes con sospecha clínica de COVID-19. MATERIALES Y MÉTODOS: Se estandarizó una prueba molecular RT-LAMP in house para la detección de SARS-CoV-2 estableciéndose el límite de detección con células Vero de cepas peruanas aisladas de SARS-CoV-2. Se validó la prueba en laboratorio con 384 muestras de hisopado nasal y faríngeo (HNF) obtenidas entre marzo y julio de 2020. Para la validación de campo se obtuvieron muestras de HNF de 383 casos sintomáticos sospechosos de COVID-19. Todas las muestras fueron evaluadas por RT-LAMP y RT-qPCR. Para la validación de laboratorio y de campo se consideró como estándar de referencia al RT-qPCR, se calcularon medidas de concordancia y rendimiento diagnóstico. RESULTADOS: El límite de detección fue consistente en los casos con umbral de ciclo (Ct) Ct < 30 en ambas pruebas, mostrando eficiencia para detectar hasta 1000 copias/µL del gen diana. Se evidenció robustez con la mitad de las concentraciones de cebadores y 20 µL de volumen final. Se identificó ausencia de amplificación para otros coronavirus humanos. La concordancia en laboratorio obtuvo un Kappa de 0,88 (IC 95%: 0,83-0,93) y en campo fue de 0,89 (IC 95%: 0,84−0,94); la sensibilidad en laboratorio fue de 87,4% (IC 95%: 80,8−92,4) y en campo fue de 88,1% (IC 95%: 81,6−92,9), la especificidad en ambos escenarios fue de 98,8% (IC 95%: 96,4−99,7). CONCLUSIONES: La prueba RT-LAMP in house fue validada por presentar una adecuada robustez, sin reacciones cruzadas, buena concordancia y rendimiento diagnóstico comparado con el RT-qPCR.
Assuntos
COVID-19 , SARS-CoV-2 , Animais , Chlorocebus aethiops , Humanos , Técnicas de Diagnóstico Molecular , Técnicas de Amplificação de Ácido Nucleico , RNA Viral , Padrões de Referência , Sensibilidade e Especificidade , Células VeroRESUMO
La mucormicosis es una enfermedad oportunista causada por un grupo de hongos filamentosos del subfilo Mucormycotina, tiene una presentación clínica variada: rino-orbito-cerebral, pulmonar, cutánea, gastrointestinal, diseminada y de sitios poco frecuentes. La mucormicosis cutánea se presenta en el 19% de los casos. Se presenta un caso de mucormicosis cutánea extensa en un paciente adulto joven, luego de quemadura por sustancia desconocida y aplicación de emplastos medicinales herbales. Tras recibir curaciones en varias oportunidades en un establecimiento de salud fue referido a un hospital de nivel 3 donde se le realizó limpieza quirúrgica y administración de antibióticos por vía endovenosa, sin mejoría clínica. Se le realizó estudio histológico de la piel afectada, cuyo informe fue inflamación intensa mixta a nivel del tejido subcutáneo, con moderado predominio de granulocitos, focos de necrosis grasa en parches, con variable inflamación. En el interior de los adipocitos necróticos, se observaron algunas estructuras con morfología de hifas fúngicas anchas, de contorno irregular morfológicamente consistentes con mucor. El paciente recibió antifúngicos combinados con curas quirúrgicas del tejido afectado en varias oportunidades, sin detener progresión de la infección. El paciente falleció.
SUMMARY Mucormycosis is an opportunistic disease caused by a group of filamentous fungi of the subphylum Mucormycotina, it has a varied clinical presentation: rhino-orbito-cerebral, pulmonary, cutaneous, gastrointestinal, disseminated and with infrequent sites. Cutaneous mucormycosis occurs in 19% of cases. A case of extensive cutaneous mucormycosis is presented in a young adult patient, after a burn caused by an unknown substance and the application of herbal medicinal plasters. After receiving cures on several occasions in a health facility, he was referred to a level 3 hospital where he underwent surgical cleaning plus administration of intravenous antibiotics, without clinical improvement; A histological study of the affected skin was performed, where intense mixed inflammation is reported at the subcutaneous tissue level, with a moderate predominance of granulocytes; as well as foci of fat necrosis in patches, with variable inflammation. Inside the necrotic adipocytes, there are some structures with wide fungal hyphae morphology, with an irregular contour morphologically consistent with mucor. The patient received antifungals combined with surgical cures of the affected tissue on several occasions, without stopping the progression of the infection; patient dies.
RESUMO
RESUMEN Objetivos: Estandarizar una prueba RT-LAMP in house para la detección de SARS-CoV-2 y validarla con muestras de laboratorio y de campo en pacientes con sospecha clínica de COVID-19. Materiales y métodos: Se estandarizó una prueba molecular RT-LAMP in house para la detección de SARS-CoV-2 estableciéndose el límite de detección con células Vero de cepas peruanas aisladas de SARS-CoV-2. Se validó la prueba en laboratorio con 384 muestras de hisopado nasal y faríngeo (HNF) obtenidas entre marzo y julio de 2020. Para la validación de campo se obtuvieron muestras de HNF de 383 casos sintomáticos sospechosos de COVID-19. Todas las muestras fueron evaluadas por RT-LAMP y RT-qPCR. Para la validación de laboratorio y de campo se consideró como estándar de referencia al RT-qPCR, se calcularon medidas de concordancia y rendimiento diagnóstico. Resultados: El límite de detección fue consistente en los casos con umbral de ciclo (Ct) Ct < 30 en ambas pruebas, mostrando eficiencia para detectar hasta 1000 copias/µL del gen diana. Se evidenció robustez con la mitad de las concentraciones de cebadores y 20 µL de volumen final. Se identificó ausencia de amplificación para otros coronavirus humanos. La concordancia en laboratorio obtuvo un Kappa de 0,88 (IC 95%: 0,83-0,93) y en campo fue de 0,89 (IC 95%: 0,84−0,94); la sensibilidad en laboratorio fue de 87,4% (IC 95%: 80,8−92,4) y en campo fue de 88,1% (IC 95%: 81,6−92,9), la especificidad en ambos escenarios fue de 98,8% (IC 95%: 96,4−99,7). Conclusiones: La prueba RT-LAMP in house fue validada por presentar una adecuada robustez, sin reacciones cruzadas, buena concordancia y rendimiento diagnóstico comparado con el RT-qPCR.
ABSTRACT Objectives: To standardize and validate an in-house RT-LAMP test for the detection of SARS-CoV-2, based on laboratory and field assays using samples from COVID-19 suspected patients. Materials and methods: An in-house SARS-CoV-2 RT-LAMP molecular test was standardized, establishing the detection limit with Vero cells of isolated Peruvian strains of SARS-CoV-2, and the robustness to various concentrations of primers. The laboratory validation was performed with 384 nasal and pharyngeal swab samples (UFH) obtained between March and July 2020. The field validation was performed with 383 UFH obtained from COVID-19 suspected symptomatic cases. All samples were tested by RT-LAMP and RT-qPCR. The RT-qPCR was considered as the reference standard test. The concordance measures and diagnostic performance were calculated. Results: The detection limit was consistent in cases with Ct <30 in both tests, showing efficiency to detect up to 1000 copies/μL of the target gene. Robustness was evidenced with half of the primer concentrations and 20 μL of final volume. Absence of amplification was identified for other HCoVs. Concordance showed a kappa index of 0.88 (95% CI: 0.83-0.93) and 0.89 (95% CI: 0.84 - 0.94) in laboratory and field settings, respectively. The sensitivity value in the laboratory was 87.4% (95% CI: 80.8 - 92.4) and 88.1% in the field (95% CI: 81.6 - 92.9). The specificity value in both settings was 98.8% (95% CI: 96.4-99.7). Conclusions: The in-house SARS-CoV-2 RT-LAMP test was successfully validated based on its adequate robustness, no cross-reactions, good concordance, and diagnostic performance compared to RT-qPCR.
Assuntos
Padrões de Referência , Técnicas de Diagnóstico Molecular , Diagnóstico , SARS-CoV-2 , Pacientes , Reação em Cadeia da Polimerase , Valor Preditivo dos Testes , Curva ROC , Sensibilidade e Especificidade , Reações Cruzadas , COVID-19RESUMO
RESUMEN Objetivos: Estandarizar una prueba RT-LAMP in house para la detección de SARS-CoV-2 y validarla con muestras de laboratorio y de campo en pacientes con sospecha clínica de COVID-19. Materiales y métodos: Se estandarizó una prueba molecular RT-LAMP in house para la detección de SARS-CoV-2 estableciéndose el límite de detección con células Vero de cepas peruanas aisladas de SARS-CoV-2. Se validó la prueba en laboratorio con 384 muestras de hisopado nasal y faríngeo (HNF) obtenidas entre marzo y julio de 2020. Para la validación de campo se obtuvieron muestras de HNF de 383 casos sintomáticos sospechosos de COVID-19. Todas las muestras fueron evaluadas por RT-LAMP y RT-qPCR. Para la validación de laboratorio y de campo se consideró como estándar de referencia al RT-qPCR, se calcularon medidas de concordancia y rendimiento diagnóstico. Resultados: El límite de detección fue consistente en los casos con umbral de ciclo (Ct) Ct < 30 en ambas pruebas, mostrando eficiencia para detectar hasta 1000 copias/µL del gen diana. Se evidenció robustez con la mitad de las concentraciones de cebadores y 20 µL de volumen final. Se identificó ausencia de amplificación para otros coronavirus humanos. La concordancia en laboratorio obtuvo un Kappa de 0,88 (IC 95%: 0,83-0,93) y en campo fue de 0,89 (IC 95%: 0,84−0,94); la sensibilidad en laboratorio fue de 87,4% (IC 95%: 80,8−92,4) y en campo fue de 88,1% (IC 95%: 81,6−92,9), la especificidad en ambos escenarios fue de 98,8% (IC 95%: 96,4−99,7). Conclusiones: La prueba RT-LAMP in house fue validada por presentar una adecuada robustez, sin reacciones cruzadas, buena concordancia y rendimiento diagnóstico comparado con el RT-qPCR.
ABSTRACT Objectives: To standardize and validate an in-house RT-LAMP test for the detection of SARS-CoV-2, based on laboratory and field assays using samples from COVID-19 suspected patients. Materials and methods: An in-house SARS-CoV-2 RT-LAMP molecular test was standardized, establishing the detection limit with Vero cells of isolated Peruvian strains of SARS-CoV-2, and the robustness to various concentrations of primers. The laboratory validation was performed with 384 nasal and pharyngeal swab samples (UFH) obtained between March and July 2020. The field validation was performed with 383 UFH obtained from COVID-19 suspected symptomatic cases. All samples were tested by RT-LAMP and RT-qPCR. The RT-qPCR was considered as the reference standard test. The concordance measures and diagnostic performance were calculated. Results: The detection limit was consistent in cases with Ct <30 in both tests, showing efficiency to detect up to 1000 copies/μL of the target gene. Robustness was evidenced with half of the primer concentrations and 20 μL of final volume. Absence of amplification was identified for other HCoVs. Concordance showed a kappa index of 0.88 (95% CI: 0.83-0.93) and 0.89 (95% CI: 0.84 - 0.94) in laboratory and field settings, respectively. The sensitivity value in the laboratory was 87.4% (95% CI: 80.8 - 92.4) and 88.1% in the field (95% CI: 81.6 - 92.9). The specificity value in both settings was 98.8% (95% CI: 96.4-99.7). Conclusions: The in-house SARS-CoV-2 RT-LAMP test was successfully validated based on its adequate robustness, no cross-reactions, good concordance, and diagnostic performance compared to RT-qPCR.
Assuntos
Estudo de Validação , Técnicas de Diagnóstico Molecular , SARS-CoV-2 , Laboratórios , Pacientes , Reação em Cadeia da Polimerase , Valor Preditivo dos Testes , Curva ROC , Sensibilidade e Especificidade , Reações Cruzadas , Diagnóstico , COVID-19RESUMO
Resumen Objetivo: Describir la respuesta clínica y mortalidad general de Colistina en infecciones por Pseudomonas XDR y Acinetobacter XDR en el Hospital Nacional Arzobispo Loayza in Lima, Peru. Métodos: Estudio observacional, descriptivo y retrospectivo. Se incluyeron los registros de pacientes > 18 años, desde junio del 2014 a junio del 2016, que tuvieron infección por Pseudomonas XDR o Acinetobacter XDR confirmada por cultivo, y que recibieron colistina. Se realizó análisis univariado de las características generales de los pacientes; un análisis bivariado con test de Chi2 , t-student o ANOVA según corresponda, y además se describió los factores asociados a mortalidad. Resultados. Se incluyeron 56 registros de pacientes, la mediana de la edad fue 46,5 [31,5 a 63,5]. El 48,2% tuvo un cultivo positivo para Pseudomonas XDR y el 51,8% para Acinetobacter XDR. La respuesta clínica favorable fue 85,7% a los 15 días y de 78,6% a los 30 días. La mortalidad intrahospitalaria a los 30 días fue 21,4%, la mortalidad en UCI fue de 30,8% y la nefrotoxicidad fue de 5,4%. Conclusiones. Colistina combinada con otro antimicrobiano tuvo una respuesta clínica favorable en infección por Pseudomonas XDR o Acinetobacter XDR.
Abstract Objective: To describe the clinical response and overall mortality of Colistin in infections by Pseudomonas XDR and Acinetobacter XDR at the Hospital Nacional Arzobispo Loayza in Lima, Peru. Methods: Observational, descriptive, retrospective study. Records of all patients > 18 years old, from June 2014 to June 2016, who had infection by Pseudomonas XDR or Acinetobacter XDR confirmed by culture, and who received colistin, were included. A univariate analysis of the general characteristics of the patients was performed; a bivariate analysis with a Chi2, t-student or ANOVA test as appropriate, and the factors associated with mortality were also determined. Results: 56 patient records were included; the median age was 46,5 [31,5 to 63,5]. The Culture was positive for Pseudomonas XDR in 48,2% and for Acinetobacter XDR in 51,8%. The favorable clinical response was 85,7% at 15 days and 78,6% at 30 days. In-hospital mortality at 30 days was 21,4%, ICU mortality was 30,8% and nephrotoxicity was 5,4%. Conclusions: Colistin combined with another antimicrobial had a favorable clinical response in infection with Pseudomonas XDR and Acinetobacter XDR.