A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.
BMC Infect Dis
; 12: 297, 2012 Nov 12.
Article
em En
| MEDLINE
| ID: mdl-23145952
ABSTRACT
BACKGROUND:
Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.METHODS:
In 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).RESULTS:
In 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.CONCLUSIONS:
Tigecycline was generally safe and effective in the treatment of cSSSIs. TRIAL REGISTRATION ClinicalTrials.gov NCT00368537.
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Dermatopatias Infecciosas
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Dermatopatias Bacterianas
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Combinação Amoxicilina e Clavulanato de Potássio
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Ampicilina
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Minociclina
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Antibacterianos
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2012
Tipo de documento:
Article