A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infectionsReportar como inadecuado




A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Infectious Diseases

, 12:297

Bacterial and fungal diseases

Abstract

BackgroundComplicated skin and skin structure infections cSSSIs frequently result in hospitalization with significant morbidity and mortality.

MethodsIn this phase 3b-4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline 100 mg initial dose, then 50 mg intravenously every 12 hrs or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus MRSA was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable CE population at the test-of-cure TOC visit. Microbiologic response and safety were also assessed. The modified intent-to-treat mITT population comprised 531 subjects tigecycline, n = 268; comparator, n = 263 and 405 were clinically evaluable tigecycline, n = 209; comparator, n = 196.

ResultsIn the CE population, 162-209 77.5% tigecycline-treated subjects and 152-196 77.6% comparator-treated subjects were clinically cured difference 0.0; 95% confidence interval CI: -8.7, 8.6. The eradication rates at the subject level for the microbiologically evaluable ME population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group difference 2.4; 95% CI: -9.6, 14.4 at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group.

ConclusionsTigecycline was generally safe and effective in the treatment of cSSSIs.

Trial registrationClinicalTrials.gov NCT00368537

KeywordsTigecycline Glycylcycline cSSSI Skin and skin structure infection Electronic supplementary materialThe online version of this article doi:10.1186-1471-2334-12-297 contains supplementary material, which is available to authorized users.

Download fulltext PDF



Autor: Peter Matthews - Marc Alpert - Galia Rahav - Denise Rill - Edward Zito - David Gardiner - Ron Pedersen - Timothy Babinchak

Fuente: https://link.springer.com/







Documentos relacionados