Back to resultsStudy Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI
Primary Purpose
Skin Diseases, Infectious
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Tigecycline
Sponsored by
About this trial
This is an interventional treatment trial for Skin Diseases, Infectious focused on measuring Tigecycline, cSSSI, complicated skin and skin structure infections
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
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
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
Full Information
NCT ID
NCT00488761
First Posted
June 18, 2007
Last Updated
December 21, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00488761
Brief Title
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI
Official Title
A Multicenter, Open Label Study to Evaluate the Safety and Efficacy of Tigecycline to Treat Complicated Skin and Skin Structure Infections (cSSSI) in Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Infectious
Keywords
Tigecycline, cSSSI, complicated skin and skin structure infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tigecycline
Primary Outcome Measure Information:
Title
The primary efficacy endpoint will be the clinical response for all clinically evaluable patients (primary population) at the test-of-cure visit
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Taiwan, medinfo@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Multiple Cities
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI
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