A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections
Matthews, P Alpert, M Rahav, G
Matthews, P
Alpert, M
Rahav, G
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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. © 2012 Matthews et al.; licensee BioMed Central Ltd.
Keywords
amoxicillin plus clavulanic acid, sultamicillin, tigecycline, vancomycin, abdominal pain, adult, anemia, antibiotic sensitivity, anxiety, article, cellulitis, comparative study, constipation, controlled study, debridement, diarrhea, dizziness, drug efficacy, drug safety, dyspepsia, Enterobacter cloacae, Enterococcus, eradication therapy, Escherichia coli, female, fever, headache, human, hypertension, hypokalemia, insomnia, intention to treat analysis, Klebsiella pneumoniae, major clinical study, male, methicillin resistant Staphylococcus aureus, microbiological examination, minimum inhibitory concentration, nausea, open study, pain, phase 3 clinical trial, phase 4 clinical trial, Proteus, pruritus, Pseudomonas aeruginosa, randomized controlled trial, side effect, skin infection, soft tissue infection, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus anginosus, Streptococcus pyogenes, surgical drainage, thorax pain, treatment outcome, vomiting, Adult, Aged, Amoxicillin-Potassium Clavulanate Combination, Ampicillin, Anti-Bacterial Agents, Female, Humans, Male, Middle Aged, Minocycline, Skin Diseases, Bacterial, Skin Diseases, Infectious, Sulbactam
Source Title
BMC Infectious Diseases
Publisher
Series/Report No.
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Rights
Attribution 4.0 International
Date
2012
DOI
10.1186/1471-2334-12-297
Type
Article