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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00488761
First received: June 18, 2007
Last updated: December 21, 2007
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Skin Diseases, Infectious
 Drug: Tigecycline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Tigecycline
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Enrollment: 50
Study Start Date: July 2006
Study Completion Date: August 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488761

Locations
Taiwan
Multiple Cities, Taiwan
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Taiwan, medinfo@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00488761     History of Changes
Other Study ID Numbers: 101993
Study First Received: June 18, 2007
Last Updated: December 21, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Tigecycline
cSSSI
complicated skin and skin structure infections

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Tigecycline
 Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013