At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Clinical diagnosis of complicated skin or skin structure infection
- ✓Requires intravenous antibiotic treatment for 4 to 14 days
- ✕Skin infection that can be treated by surgery and wound care alone
- ✕Diabetic foot ulcers or bedsores with infection present longer than 1 week
- ✕Poor circulation likely to result in amputation of the infected site within 1 month
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Open-Label Comparison of the Safety And Efficacy of Tigecycline With That of Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Complicated Skin And Skin Structure Infections
In Brief
A Phase 4 clinical trial evaluating Tigecycline and ampicillin-sulbactam for Skin Diseases, Bacterial. Completed, enrolled 550 participants across 57 sites in 12 countries.
Detailed Summary
The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).
Study Details
Timeline
Interventions
Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs. A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued.