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

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Alpert M., Rahav G., Rill D., Zito E., Gardiner D., Pedersen R., ...Daha Fazla

BMC Infectious Diseases, cilt.12, 2012 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 12
  • Basım Tarihi: 2012
  • Doi Numarası: 10.1186/1471-2334-12-297
  • Dergi Adı: BMC Infectious Diseases
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Anahtar Kelimeler: Tigecycline, Glycylcycline, cSSSI, Skin and skin structure infection, SOFT-TISSUE INFECTIONS, STAPHYLOCOCCUS-AUREUS, IN-VITRO, ANTIMICROBIAL AGENTS, VANCOMYCIN-AZTREONAM, PRACTICE GUIDELINES, DISEASES SOCIETY, GAR-936, EFFICACY, PHASE-3
  • Dokuz Eylül Üniversitesi Adresli: Evet

Özet

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.