Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

Phase 4

Completed

• Conditions: Skin Diseases, Bacterial
• Interventions: Drug: Tigecycline; Drug: ampicillin-sulbactam

• Registration Number: NCT00368537
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-21
• Study First Submitted QC: 2006-08-23
• Study First Posted: 2006-08-24
• Study Start: 2006-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-30
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-08
• Last Update Submitted: 2012-08-08
• Results First Posted: 2012-08-09
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tigecycline	Arm 1: Tigecycline
2	ampicillin-sulbactam	Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide

Primary Outcome Measures

Name	Time	Method
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit	up to 6 weeks	Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made.

Secondary Outcome Measures

Name	Time	Method
Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit	up to 6 weeks	Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. ME population were subjects who were CE and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. TOC performed 8-50 days after last dose of study drug.
Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit	up to 6 weeks	Microbiological response assessed at patient level. Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for patients with a clinical response of failure; Superinfection=culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.
Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate	up to 6 weeks	In vitro activity of the study drugs against a range of pathogenic bacteria that cause complicated skin and skin structure infection (cSSSI) were analyzed using MIC. MIC 50 and MIC 90 are the lowest concentrations of a drug that inhibit the growth of 50% and 90% of a microorganism, respectively. TOC performed 8-50 days after last dose of study drug.
Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients	up to 6 weeks	Healthcare resource utilization assessment included intensive care unit (ICU) and non-ICU inpatient hospitalization. TOC performed 8-50 days after last dose of study drug.