Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI

Phase 4

Completed

• Conditions: Skin Diseases, Infectious

• Registration Number: NCT00488761
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Tigecycline's activity against resistant organisms, as well as significant coverage of both gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in treating patients with complicated skin and/or skin structure infections.

Detailed Description

To evaluate the safety and the efficacy of tigecycline in treating hospitalized patients with complicated skin and/or skin structure infections.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-06-18
• Study First Submitted QC: 2007-06-18
• Study First Posted: 2007-06-20
• Study Completion: 2007-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-21
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Hospitalized male and female patients, 18 years of age or older.
• Anticipated need for intravenous antibiotic therapy of 5 days or longer.
• Patients known or suspected to have a complicated skin and skin structure infection.

Exclusion Criteria

• Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
• Patients with severely impaired arterial blood supply and insufficiency such that the likelihood of amputation of the infected anatomical site within one month is likely.
• Infected diabetic foot ulcers or decubitus ulcers where the infection is present for greater than one week's duration or chronically infected decubitus ulcers in patients who can not be compliant with measures necessary for chronic wound healing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint will be the clinical response for all clinically evaluable patients (primary population) at the test-of-cure visit

Secondary Outcome Measures

Name	Time	Method
microbiological response at the patient level microbiological response at the pathogen level clinical cure rates by baseline pathogen response rates for patients with polymicrobial and monomicrobial infections