Phase 4
N=550
Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections
Skin Diseases, Bacterial
Bottom Line
View on ClinicalTrials.gov: NCT00368537 ↗Enrolled (actual)
550
Serious AEs
12.6%
Results posted
Aug 2012
Primary outcome: Primary: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit — 162; 152 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tigecycline (Drug); ampicillin-sulbactam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit |
162; 152 | — |
| SECONDARY Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit |
96; 77 | — |
| SECONDARY Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit |
95; 76; 25; 23; 2; 1 | — |
| SECONDARY Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate |
0.12; 1.00; 0.25; 1.00; 0.25; 8.00 | — |
| SECONDARY Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients |
6; 9; 268; 263 | 0.444 |
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).
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of complicated skin or skin structure infection
- Male or female, 18 years or older
- Need for intravenous treatment for 4 to 14 days
Exclusion Criteria
- Skin infection that can be treated by surgery & wound care alone
- Diabetic foot ulcers or bedsores where the infection is present longer than 1 week
- Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply
Data sourced from ClinicalTrials.gov (NCT00368537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.