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1.
Am J Respir Crit Care Med ; 198(2): 256-263, 2018 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-29546996

RESUMO

Pneumonia is a complex pulmonary disease in need of new clinical approaches. Although triggered by a pathogen, pneumonia often results from dysregulations of host defense that likely precede infection. The coordinated activities of immune resistance and tissue resilience then dictate whether and how pneumonia progresses or resolves. Inadequate or inappropriate host responses lead to more severe outcomes such as acute respiratory distress syndrome and to organ dysfunction beyond the lungs and over extended time frames after pathogen clearance, some of which increase the risk for subsequent pneumonia. Improved understanding of such host responses will guide the development of novel approaches for preventing and curing pneumonia and for mitigating the subsequent pulmonary and extrapulmonary complications of pneumonia. The NHLBI assembled a working group of extramural investigators to prioritize avenues of host-directed pneumonia research that should yield novel approaches for interrupting the cycle of unhealthy decline caused by pneumonia. This report summarizes the working group's specific recommendations in the areas of pneumonia susceptibility, host response, and consequences. Overarching goals include the development of more host-focused clinical approaches for preventing and treating pneumonia, the generation of predictive tools (for pneumonia occurrence, severity, and outcome), and the elucidation of mechanisms mediating immune resistance and tissue resilience in the lung. Specific areas of research are highlighted as especially promising for making advances against pneumonia.


Assuntos
Suscetibilidade a Doenças/fisiopatologia , Interações entre Hospedeiro e Microrganismos/fisiologia , Pulmão/fisiopatologia , Pneumonia/fisiopatologia , Relatório de Pesquisa , Síndrome do Desconforto Respiratório/fisiopatologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Infecções Bacterianas/fisiopatologia , Congressos como Assunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , National Heart, Lung, and Blood Institute (U.S.) , Estados Unidos , Viroses/fisiopatologia
2.
Transplant Cell Ther ; 29(2): 123.e1-123.e10, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36442769

RESUMO

Allogeneic hematopoietic cell transplantation is a curative procedure for hematologic malignancies but is associated with a significant risk of non-relapse mortality (NRM). The Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) is a prognostic tool that discriminates this risk in all age groups. A recent survey of transplant physicians demonstrated that 79% of pediatric providers used the HCT-CI infrequently, and most reported concerns about its applicability in the younger population. We conducted a retrospective study using the Center for International Blood and Marrow Transplant Research database to examine the impact of expanded HCT-CI definitions on NRM in pediatric and young adult patients with hematologic malignancies. We included 5790 patients <40 years old receiving allogeneic transplants between 2008 and 2017 to examine broader definitions of comorbidities in the HCT-CI, including history of mechanical ventilation and fungal infection, estimated glomerular filtration rate, and body mass index (BMI) percentiles. Multivariable Fine-Gray models were created to determine the effect of each HCT-CI defining comorbidity and its modification on NRM and were used to develop 2 novel risk scores. We next developed the expanded HCT-CI for children and young adults (youth with malignancies; expanded ymHCT-CI), where 23% patients had an increased comorbidity score, compared to the HCT-CI. Comorbidities with hazard ratio < 1.2 were then removed to create the simplified HCT-CI for children and young adults (youth with malignancies; simplified ymHCT-CI), which demonstrated higher scores corresponded to a greater risk of NRM (P < .001). These novel comorbidity indexes with broader definitions are more relevant to pediatric and young adult patients, and prospective studies are needed to validate these in the younger patient population. It remains to be seen whether the development of these pediatric-specific and practical risk indexes increases their use by the pediatric transplant community.


Assuntos
Neoplasias Hematológicas , Transplante de Células-Tronco Hematopoéticas , Humanos , Adolescente , Adulto Jovem , Criança , Adulto , Estudos Retrospectivos , Transplante Homólogo , Recidiva Local de Neoplasia , Transplante de Células-Tronco Hematopoéticas/métodos , Neoplasias Hematológicas/terapia , Neoplasias Hematológicas/epidemiologia
3.
Ann Am Thorac Soc ; 18(7): 1087-1097, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34242148

RESUMO

Pneumonia causes a significant burden of disease worldwide. Although all populations are at risk of pneumonia, those at extremes of age and those with immunosuppressive disorders, underlying respiratory disease, and critical illness are particularly vulnerable. Although clinical practice guidelines addressing the management and treatment of pneumonia exist, few of the supporting studies focus on the crucial contributions of the host in pneumonia pathogenesis and recovery. Such essential considerations include the host risk factors that lead to susceptibility to lung infections; biomarkers reflecting the host response and the means to pursue host-directed pneumonia therapy; systemic effects of pneumonia on the host; and long-term health outcomes after pneumonia. To address these gaps, the Pneumonia Working Group of the Assembly on Pulmonary Infection and Tuberculosis led a workshop held at the American Thoracic Society meeting in May 2018 with overarching objectives to foster attention, stimulate research, and promote funding for short-term and long-term investigations into the host contributions to pneumonia. The workshop involved participants from various disciplines with expertise in lung infection, pneumonia, sepsis, immunocompromised patients, translational biology, data science, genomics, systems biology, and clinical trials. This workshop report summarizes the presentations and discussions and important recommendations for future clinical pneumonia studies. These recommendations include establishing consensus disease and outcome definitions, improved phenotyping, development of clinical study networks, standardized data and biospecimen collection and protocols, and development of innovative trial designs.


Assuntos
Pneumonia , Consenso , Estado Terminal , Humanos , Hospedeiro Imunocomprometido , Pneumonia/terapia , Relatório de Pesquisa , Estados Unidos
4.
JAMA Netw Open ; 3(1): e1918668, 2020 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-31913492

RESUMO

Importance: Patients undergoing hematopoietic stem cell transplant (HSCT) are at risk for bloodstream infection (BSI) secondary to translocation of bacteria through the injured mucosa, termed mucosal barrier injury-laboratory confirmed bloodstream infection (MBI-LCBI), in addition to BSI secondary to indwelling catheters and infection at other sites (BSI-other). Objective: To determine the incidence, timing, risk factors, and outcomes of patients who develop MBI-LCBI in the first 100 days after HSCT. Design, Setting, and Participants: A case-cohort retrospective analysis was performed using data from the Center for International Blood and Marrow Transplant Research database on 16 875 consecutive pediatric and adult patients receiving a first allogeneic HSCT from January 1, 2009, to December 31, 2016. Patients were classified into 4 categories: MBI-LCBI (1481 [8.8%]), MBI-LCBI and BSI-other (698 [4.1%]), BSI-other only (2928 [17.4%]), and controls with no BSI (11 768 [69.7%]). Statistical analysis was performed from April 5 to July 17, 2018. Main Outcomes and Measures: Demographic characteristics and outcomes, including overall survival, chronic graft-vs-host disease, and transplant-related mortality (only for patients with malignant disease), were compared among groups. Results: Of the 16 875 patients in the study (9737 [57.7%] male; median [range] age, 47 [0.04-82] years) 13 686 (81.1%) underwent HSCT for a malignant neoplasm, and 3189 (18.9%) underwent HSCT for a nonmalignant condition. The cumulative incidence of MBI-LCBI was 13% (99% CI, 12%-13%) by day 100, and the cumulative incidence of BSI-other was 21% (99% CI, 21%-22%) by day 100. Median (range) time from transplant to first MBI-LCBI was 8 (<1 to 98) days vs 29 (<1 to 100) days for BSI-other. Multivariable analysis revealed an increased risk of MBI-LCBI with poor Karnofsky/Lansky performance status (hazard ratio [HR], 1.21 [99% CI, 1.04-1.41]), cord blood grafts (HR, 2.89 [99% CI, 1.97-4.24]), myeloablative conditioning (HR, 1.46 [99% CI, 1.19-1.78]), and posttransplant cyclophosphamide graft-vs-host disease prophylaxis (HR, 1.85 [99% CI, 1.38-2.48]). One-year mortality was significantly higher for patients with MBI-LCBI (HR, 1.81 [99% CI, 1.56-2.12]), BSI-other (HR, 1.81 [99% CI, 1.60-2.06]), and MBI-LCBI plus BSI-other (HR, 2.65 [99% CI, 2.17-3.24]) compared with controls. Infection was more commonly reported as a cause of death for patients with MBI-LCBI (139 of 740 [18.8%]), BSI (251 of 1537 [16.3%]), and MBI-LCBI plus BSI (94 of 435 [21.6%]) than for controls (566 of 4740 [11.9%]). Conclusions and Relevance: In this cohort study, MBI-LCBI, in addition to any BSIs, were associated with significant morbidity and mortality after HSCT. Further investigation into risk reduction should be a clinical and scientific priority in this patient population.


Assuntos
Bacteriemia/epidemiologia , Infecção Hospitalar/epidemiologia , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Mucosa/lesões , Adulto , Bacteriemia/sangue , Infecções Relacionadas a Cateter/epidemiologia , Infecções Relacionadas a Cateter/microbiologia , Infecção Hospitalar/microbiologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Mucosa/microbiologia , Estudos Retrospectivos , Fatores de Risco
5.
Int J Infect Dis ; 10(2): 136-47, 2006 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-16183318

RESUMO

OBJECTIVES: A pooled analysis of 14 Phase III studies was performed to establish the clinical and bacteriologic efficacy of telithromycin 800 mg once daily in the treatment of pneumococcal community-acquired respiratory tract infections (RTIs). METHODS: Data were examined from 5534 adult/adolescent patients with community-acquired pneumonia (CAP), acute exacerbations of chronic bronchitis (AECB), or acute bacterial sinusitis, who had received telithromycin for 5-10 days or a comparator antibacterial. RESULTS: Streptococcus pneumoniae was identified in 704/2060 (34.2%) bacteriologically evaluable patients. The respective per-protocol clinical cure rates for telithromycin and comparators were 94.3% and 90.0% (CAP); 81.5% and 78.9% (AECB); 90.1% and 87.5% (acute sinusitis); 92.7% and 87.6% (all indications). Clinical cure rates were 28/34 (82.4%) and 5/7, respectively, for penicillin-resistant infections, and 44/52 (84.6%) and 11/14, respectively, for erythromycin-resistant infections. Of 82 patients with pneumococcal bacteremia, 74 (90.2%) were clinically cured after telithromycin treatment, including 5/7 and 8/10 with penicillin- or erythromycin-resistant strains, respectively. Adverse events considered possibly related to study medication were reported by 1071/4045 (26.5%) telithromycin and 505/1715 (29.4%) comparator recipients. These events were generally of mild/moderate severity, and mainly gastrointestinal in nature. CONCLUSIONS: As S. pneumoniae is the leading bacterial cause of community-acquired RTIs, and antibacterial resistance is increasing among this species, these findings support the use of telithromycin as first-line therapy in this setting.


Assuntos
Antibacterianos/uso terapêutico , Infecções Comunitárias Adquiridas/tratamento farmacológico , Cetolídeos/uso terapêutico , Infecções Pneumocócicas/tratamento farmacológico , Infecções Respiratórias/tratamento farmacológico , Adolescente , Adulto , Idoso , Antibacterianos/administração & dosagem , Ensaios Clínicos Fase III como Assunto , Feminino , Seguimentos , Humanos , Cetolídeos/administração & dosagem , Masculino , Testes de Sensibilidade Microbiana , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Streptococcus pneumoniae/efeitos dos fármacos , Streptococcus pneumoniae/isolamento & purificação , Resultado do Tratamento
6.
Chest ; 128(4): 1980-8, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16236845

RESUMO

STUDY OBJECTIVES: To demonstrate equivalence in the clinical efficacy of telithromycin vs clarithromycin treatment of outpatients with acute exacerbations of chronic bronchitis (AECB), and to compare the tolerability and respiratory-related health-care resource utilization associated with these treatment regimens. DESIGN AND PATIENTS: A randomized, double-blind, multicenter, clinical study was conducted at 105 centers in 14 countries. Adult outpatients (age > or = 30 years) received oral telithromycin, 800 mg qd for 5 days (n = 270), or oral clarithromycin, 500 mg bid for 10 days (n = 282), for the treatment of AECB. Clinical and bacteriologic outcomes were assessed at the posttherapy/test-of-cure (TOC) visit (days 17 to 24; per-protocol population). Health-care resource utilization data were collected for each patient by investigators blinded to study medication up to the late posttherapy visit (days 31 to 36). RESULTS: Clinical cure rates at the posttherapy/TOC visit were comparable between the groups (telithromycin, 193 of 225 patients [85.8%]; clarithromycin, 206 of 231 patients [89.2%]); bacteriologic outcome was satisfactory for 59 of 72 telithromycin-treated patients (81.9%) vs 63 of 76 clarithromycin-treated patients (82.9%). Health-care resource utilization assessed up to the late posttherapy visit was lower in the telithromycin treatment group than the clarithromycin treatment group, with significantly fewer hospitalizations for respiratory-related causes (one hospitalization vs eight hospitalizations for a total of 4 inpatient days vs 39 inpatient days, respectively), significantly fewer AECB-related emergency department visits (0 vs 8), and fewer unscheduled outpatient visits (11 vs 18). Fewer telithromycin-treated patients reported days lost from work (21 of 91 patients [23.1%]; 133 days) compared with those receiving clarithromycin (30 of 98 patients [30.6%]; 141 days). Telithromycin was well tolerated; adverse events considered possibly related to study medication were reported by 61 of 269 patients (22.7%) and 100 of 280 patients (35.7%) receiving telithromycin and clarithromycin, respectively. CONCLUSIONS: In this study, 5-day telithromycin treatment was as effective and well tolerated as 10-day clarithromycin treatment for patients with AECB, and was associated with a reduced utilization of health-care resources.


Assuntos
Bronquite/tratamento farmacológico , Claritromicina/uso terapêutico , Cetolídeos/uso terapêutico , Doença Aguda , Adulto , Idoso , Doença Crônica , Claritromicina/administração & dosagem , Progressão da Doença , Método Duplo-Cego , Esquema de Medicação , Feminino , Volume Expiratório Forçado , Alocação de Recursos para a Atenção à Saúde , Humanos , Cetolídeos/administração & dosagem , Masculino , Pessoa de Meia-Idade , Método Simples-Cego , Fumar , Capacidade Vital
7.
Diagn Microbiol Infect Dis ; 52(1): 45-52, 2005 May.
Artigo em Inglês | MEDLINE | ID: mdl-15878442

RESUMO

The pharmacodynamics of telithromycin, a new ketolide antibacterial, was examined in 115 patients with community-acquired pneumonia (CAP). Patients received telithromycin 800 mg qd for 7-10 days. Pharmacokinetic parameters were determined, and exposure was linked to microbiological outcome using logistic regression analysis. A breakpoint for increased probability of microbiological eradication was developed and was found to be the ratio of area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC) of 3.375. The final logistic regression model of microbiological outcome included body weight and AUC/MIC ratio breakpoint. This model was found in analyses of the entire population and when Streptococcus pneumoniae and Haemophilus influenzae were examined separately. The AUC/MIC ratio target attainment rate is expected to be >99.9% for S. pneumoniae and Moraxella catarrhalis and 93.1% for H. influenzae. This study demonstrated a relationship between telithromycin drug exposure and microbiological outcome. Telithromycin is expected to achieve the drug exposure breakpoint for the majority of isolates causing CAP.


Assuntos
Antibacterianos , Infecções Comunitárias Adquiridas/tratamento farmacológico , Cetolídeos , Pneumonia Bacteriana/tratamento farmacológico , Antibacterianos/administração & dosagem , Antibacterianos/farmacocinética , Antibacterianos/uso terapêutico , Infecções Comunitárias Adquiridas/microbiologia , Haemophilus influenzae/efeitos dos fármacos , Humanos , Cetolídeos/administração & dosagem , Cetolídeos/farmacocinética , Cetolídeos/uso terapêutico , Testes de Sensibilidade Microbiana , Moraxella catarrhalis/efeitos dos fármacos , Pneumonia Bacteriana/microbiologia , Streptococcus pneumoniae/efeitos dos fármacos , Resultado do Tratamento
8.
Curr Med Res Opin ; 20(5): 749-56, 2004 May.
Artigo em Inglês | MEDLINE | ID: mdl-15140342

RESUMO

AIMS: To compare the impact on hospitalization rates and the clinical efficacy of oral telithromycin and clarithromycin treatment in patients with community-acquired pneumonia (CAP). PATIENTS AND METHODS: Outpatients aged >or= 18 years (n = 448) with CAP were enrolled in a randomized, double-blind, multinational study and received telithromycin 800 mg once daily (n = 224) or clarithromycin 500 mg twice daily (n = 224) for 10 days. The primary outcome measure was clinical efficacy at post-therapy/test of cure (Days 17-24) in the per-protocol population. Frequency of CAP-related hospitalizations, physician visits/tests/procedures, and additional respiratory tract infection-related antibacterial use were compared by treatment group (intent to treat population) up to the late post-therapy visit (Days 31-36). Study investigators who were blinded to the treatment arm assessed whether hospital admissions were CAP related or not. Hospitalization costs (USdollars) associated with telithromycin and clarithromycin treatment were compared. RESULTS: Per-protocol clinical cure rates for telithromycin and clarithromycin were statistically reduced number of hospitalizations/days required equivalent (88.3% [143/162] vs 88.5% [138/156] - difference: -0.2%; 95% CI: -7.8, 7.5). There were four CAP-related hospitalizations (1.8 events/100 patients) among patients treated with telithromycin vs eight (3.6 events/100 patients) among clarithromycin patients (p = 0.281). Total CAP-related hospitalization costs for telithromycin and clarithromycin patients were $25 360 vs $70 567, respectively (difference: -20 182 per 100 patients; 95% CI: -49 531; 9168) [corrected]. CONCLUSIONS: This study demonstrates that telithromycin is an effective therapy for outpatients with CAP. There were no significant differences in hospitalization rates between treatments; however, a tendency towards a numerically in hospital among telithromycin patients was observed. This could potentially translate into reduced hospitalization costs for telithromycin vs clarithromycin in the treatment of CAP.


Assuntos
Antibacterianos/uso terapêutico , Claritromicina/uso terapêutico , Infecções Comunitárias Adquiridas/tratamento farmacológico , Hospitalização/estatística & dados numéricos , Cetolídeos , Macrolídeos/uso terapêutico , Pneumonia/tratamento farmacológico , Administração Oral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Antibacterianos/administração & dosagem , Claritromicina/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Macrolídeos/administração & dosagem , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
9.
Curr Med Res Opin ; 20(7): 969-80, 2004 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15265241

RESUMO

AIMS: To compare hospitalization rates among patients with community-acquired pneumonia (CAP) treated with oral telithromycin and clarithromycin, based on pooled data from two randomized, double-blind, multinational clinical trials. PATIENTS AND METHODS: Adult patients with CAP eligible for oral therapy (Study 1, n = 448; Study 2, n = 575) received telithromycin 800 mg once daily for 10 (Study 1, 2-arms), 5 or 7 (Study 2, 3-arms) days, or clarithromycin 500 mg twice daily for 10 days. Frequency of CAP-related hospitalizations, physician visits/tests/procedures, and additional respiratory tract infection-related antibacterial use, as well as CAP-related length of hospital stay and hospitalization costs, were compared by treatment group (intent to treat populations) up until the late post-therapy visit (Days 31-36). Study investigators blinded to treatment regimen assessed whether hospital admissions were CAP related. RESULTS: Despite equivalent clinical efficacy for telithromycin vs clarithromycin in the clinically evaluable per-protocol populations (n = 784) (88.8% [428/482] vs 90.1% [272/302]--difference: -1.3%; 95% CI: -6.0, 3.4), telithromycin treatment for 5, 7, or 10 days was associated with significantly fewer CAP-related hospitalizations (p = 0.023) and CAP-related hospital days (p = 0.025) vs clarithromycin (reduction of 2.3 hospitalizations and 23.4 hospital days per 100 patients). Accordingly, estimated CAP-related hospitalization costs were significantly lower (p = 0.025) for telithromycin recipients (30,231 US dollars less per 100 patients). CAP-related hospitalizations, duration of hospital stay, and hospitalization costs for 7- to 10-day telithromycin--the approved dosing regimen for CAP--were significantly lower (p = 0.023, 0.025, and 0.025, respectively) than for clarithromycin. CONCLUSIONS: Data from this study indicate that telithromycin 800 mg once daily for 5, 7, or 10 days provides an effective therapy for patients with CAP, and may be associated with fewer CAP-related hospitalizations and hospital days than clarithromycin 500 mg twice daily for 10 days. Treatment with telithromycin could, therefore, potentially translate into cost savings in the management of CAP.


Assuntos
Antibacterianos/uso terapêutico , Claritromicina/uso terapêutico , Infecções Comunitárias Adquiridas/tratamento farmacológico , Hospitalização/estatística & dados numéricos , Cetolídeos/uso terapêutico , Pneumonia Bacteriana/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Feminino , Hospitalização/tendências , Humanos , Macrolídeos/uso terapêutico , Masculino , Pessoa de Meia-Idade
10.
J Infect ; 49(2): 115-25, 2004 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-15236918

RESUMO

OBJECTIVES: To investigate the correlation between in vitro susceptibility of isolates and clinical outcomes with telithromycin in respiratory tract infections. METHODS: The activity of telithromycin was determined by in vitro susceptibility testing of key respiratory tract pathogens isolated from patients with community-acquired pneumonia, acute exacerbations of chronic bronchitis or acute maxillary sinusitis enrolled in 14 Phase III/IV clinical trials evaluating the clinical efficacy of telithromycin. RESULTS: In this pooled analysis, telithromycin mode minimum inhibitory concentration (MIC) and MIC90, respectively, were: 0.016 and 0.03 mg/l against Streptococcus pneumoniae (n=626); 0.03 and 0.5 mg/l for penicillin-resistant S. pneumoniae (n=56); 0.03 and 1 mg/l for erythromycin-resistant S. pneumoniae (n=81); 2 and 4 mg/l against Haemophilus influenzae (including beta-lactamase producers; n=627); both 0.12 mg/l for Moraxella catarrhalis (n=159) and both 0.25 mg/l for Staphylococcus aureus (n=124). Telithromycin (5 or 7-10 days) resulted in overall clinical and bacteriologic success rates of 88.1% (1593/1808) and 89% (1593/1789), respectively. CONCLUSIONS: High levels of in vitro susceptibility to telithromycin are paralleled by high rates of clinical cure and bacteriologic eradication.


Assuntos
Bactérias/efeitos dos fármacos , Bronquite/tratamento farmacológico , Infecções Comunitárias Adquiridas/tratamento farmacológico , Cetolídeos , Macrolídeos/farmacologia , Pneumonia/tratamento farmacológico , Sinusite/tratamento farmacológico , Doença Aguda , Adolescente , Adulto , Bronquite/microbiologia , Doença Crônica , Ensaios Clínicos Fase III como Assunto , Ensaios Clínicos Fase IV como Assunto , Infecções Comunitárias Adquiridas/microbiologia , Feminino , Humanos , Técnicas In Vitro , Masculino , Testes de Sensibilidade Microbiana , Pneumonia/microbiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Sinusite/microbiologia
11.
South Med J ; 98(9): 863-8, 2005 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-16217977

RESUMO

OBJECTIVE: Telithromycin, the first approved ketolide antibiotic, was developed to treat community-acquired respiratory tract infections, including acute bacterial maxillary sinusitis (ABMS). A previously published study showed that a 5-day course of 800 mg telithromycin once daily is as effective as a 10-day course in the treatment of ABMS. MATERIALS AND METHODS: Data were pooled from two controlled, multinational, prospective, randomized, double-blinded ABMS trials comparing 5-day telithromycin (800 mg once daily) with 10-day amoxicillin-clavulanate (500/125 mg 3 times daily) and cefuroxime axetil (250 mg twice daily). Clinical cure and bacteriologic eradication rates were compared by means of descriptive statistics. RESULTS: The clinical cure rate for telithromycin was 80.9% versus 77.4% for comparators; bacteriologic eradication rate for telithromycin was 84.9% versus 81.7% for comparators. Most adverse events were mild to moderate in intensity and, most commonly, gastrointestinal in nature. CONCLUSIONS: These results support the conclusion that 5 days of treatment with telithromycin is as safe and effective in patients with ABMS as a 10-day course of treatment with amoxicillin-clavulanate or cefuroxime axetil.


Assuntos
Antibacterianos/uso terapêutico , Cetolídeos/uso terapêutico , Sinusite Maxilar/tratamento farmacológico , Doença Aguda , Adolescente , Adulto , Idoso , Combinação Amoxicilina e Clavulanato de Potássio/uso terapêutico , Cefuroxima/análogos & derivados , Cefuroxima/uso terapêutico , Método Duplo-Cego , Esquema de Medicação , Feminino , Haemophilus influenzae/isolamento & purificação , Humanos , Masculino , Sinusite Maxilar/microbiologia , Pessoa de Meia-Idade , Moraxella catarrhalis/isolamento & purificação , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Staphylococcus aureus/isolamento & purificação , Streptococcus pneumoniae/isolamento & purificação
12.
J Infect ; 51(3): 201-5, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16230216

RESUMO

The efficacy of oral telithromycin 800mg once daily for 7 days was evaluated in a multicentre, multinational study in patients with community-acquired pneumonia caused by Streptococcus pneumoniae resistant to penicillin and/or erythromycin. Per-protocol clinical and bacteriological outcomes were assessed 10-17 days post-therapy. Of the 129 patients with S. pneumoniae infection, 16 were infected with strains resistant to penicillin and/or erythromycin. Fifteen of these 16 patients (93.8%) were assessed as clinically and bacteriologically cured at the post-therapy visit.


Assuntos
Infecções Comunitárias Adquiridas/tratamento farmacológico , Farmacorresistência Bacteriana , Cetolídeos/uso terapêutico , Pneumonia Pneumocócica/tratamento farmacológico , Administração Oral , Adulto , Idoso , Antibacterianos/administração & dosagem , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Infecções Comunitárias Adquiridas/microbiologia , Eritromicina/farmacologia , Feminino , Humanos , Cetolídeos/administração & dosagem , Masculino , Testes de Sensibilidade Microbiana , Pessoa de Meia-Idade , Resistência às Penicilinas , Penicilinas/farmacologia , Pneumonia Pneumocócica/microbiologia , Resultado do Tratamento
13.
J Antimicrob Chemother ; 54(2): 515-23, 2004 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-15269191

RESUMO

OBJECTIVES: This study was conducted to investigate the potential equivalence in clinical efficacy and assess safety of a 5 or 7 day regimen of oral telithromycin (800 mg once daily) and a 10 day regimen of oral clarithromycin (500 mg twice daily) in treating community-acquired pneumonia (CAP). Bacteriological efficacy was also compared. METHODS: This was a multicentre, randomized, double-blind, active-controlled study. Patients with mild to moderate CAP received telithromycin 800 mg once a day for 5 (n=193) or 7 (n=195) days or clarithromycin 500 mg twice a day for 10 days (n=187). In these groups, 159, 161 and 146 patients, respectively, completed the study. RESULTS: At the post-therapy/test-of-cure evaluation, clinical cure rates (per-protocol clinical population) were 89.3% (5 days) and 88.8% (7 days) for telithromycin, and 91.8% for clarithromycin 10 days. Satisfactory bacteriological outcome rates (per-protocol bacteriological population) were 87.7% and 80.0% for 5 and 7 days of telithromycin, respectively, and 83.3% for 10 days of clarithromycin. Bacteriological eradication rates in the respective treatment groups were, for Streptococcus pneumoniae, 95.8% (23/24), 96.7% (29/30) and 88.5% (23/26); for Haemophilus influenzae, 88.0% (22/25), 84.0% (21/25) and 88.2% (15/17) and for Moraxella catarrhalis, 1/1, 4/5 and 3/4. Both telithromycin regimens demonstrated clinical efficacy against pneumococcal bacteraemia (19/19), atypical pathogens (9/9) and erythromycin-resistant S. pneumoniae isolates (5/5). Most treatment-emergent adverse events were mild to moderate in intensity with most commonly reported adverse events involving the gastrointestinal system. CONCLUSIONS: Telithromycin 800 mg administered once a day for 5 or 7 days was as effective and safe as clarithromycin 500 mg administered twice a day for 10 days in treating patients with CAP caused by common respiratory pathogens, including macrolide-resistant isolates, and pneumococcal bacteraemia.


Assuntos
Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Claritromicina/administração & dosagem , Claritromicina/uso terapêutico , Infecções Comunitárias Adquiridas/tratamento farmacológico , Cetolídeos , Macrolídeos/administração & dosagem , Macrolídeos/uso terapêutico , Pneumonia/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/efeitos adversos , Infecções Comunitárias Adquiridas/microbiologia , Método Duplo-Cego , Farmacorresistência Bacteriana , Eletrocardiografia/efeitos dos fármacos , Indução Enzimática/efeitos dos fármacos , Feminino , Haemophilus influenzae/efeitos dos fármacos , Humanos , Testes de Função Hepática , Macrolídeos/efeitos adversos , Masculino , Pessoa de Meia-Idade , Moraxella catarrhalis/efeitos dos fármacos , Pneumonia/microbiologia , Tamanho da Amostra , Escarro/microbiologia , Streptococcus pneumoniae/efeitos dos fármacos , Resultado do Tratamento
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