Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI
NCT00488761
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI | ||||||
| Official Title ICMJE | 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 | ||||||
| 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 Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Skin Diseases, Infectious | ||||||
| Intervention ICMJE | Drug: Tigecycline | ||||||
| Study Arms ICMJE | Not Provided | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 50 | ||||||
| Original Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | August 2007 | ||||||
| Primary Completion Date | Not Provided | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Taiwan | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00488761 | ||||||
| Other Study ID Numbers ICMJE | 101993 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Not Provided | ||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Verification Date | December 2007 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||