A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.

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.

• Authors: Peter Matthews, Marc Alpert, Galia Rahav, Denise Rill, Edward Zito, David Gardiner, Ron Pedersen, Timothy Babinchak, Paul C McGovern, Tigecycline 900 cSSSI Study Group
• Journal: BMC infectious diseases (BMC Infect Dis) Vol. 12 Pg. 297 (Nov 12 2012) ISSN: 1471-2334 [Electronic] England
• PMID: 23145952 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• sultamicillin
• Tigecycline
• Amoxicillin-Potassium Clavulanate Combination
• Ampicillin
• Minocycline
• Sulbactam

Topics

• Adult
• Aged
• Amoxicillin-Potassium Clavulanate Combination (adverse effects, therapeutic use)
• Ampicillin (adverse effects, therapeutic use)
• Anti-Bacterial Agents (adverse effects, therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Minocycline (adverse effects, analogs & derivatives, therapeutic use)
• Skin Diseases, Bacterial (drug therapy)
• Skin Diseases, Infectious (drug therapy)
• Sulbactam (adverse effects, therapeutic use)
• Tigecycline