Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections
NCT00228410
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- Anticipated need for intravenous antibiotic therapy of 5 days or longer.
- Patients known or suspected to have a complicated skin and skin structure infection. Complicated skin/skin structure infection includes infections either involving deeper soft tissue or requiring significant surgical intervention or a significant underlying disease state (such as diabetes mellitus, peripheral vascular disease, peripheral neuropathy, lower venous insufficiency) that complicates response to treatment.
Other inclusion applies
- 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.
- Necrotizing fasciitis or gangrene.
Other exclusion applies.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections | |||
| Official Title ICMJE | A Multicenter, Randomized, Double-Blind Comparison of the Safety and Efficacy of Tigecycline With Those of Vancomycin With Aztreonam to Treat Complicated Skin and Skin Structure Infections in Hospitalized Patients. | |||
| Brief Summary | To compare the safety and the efficacy of tigecycline to vancomycin with aztreonam in treating hospitalized patients with complicated skin and/or skin structure infections. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Skin Diseases, Infectious | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Teras J, Gardovskis J, Vaasna T, Kupcs U, Pupelis G, Dukart G, Dartois N, Jouve S, Cooper A; 305 Study Group. Overview of tigecycline efficacy and safety in the treatment of complicated skin and skin structure infections - a European perspective. J Chemother. 2008 Oct;20 Suppl 1:20-7. | |||
* 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 | 503 | |||
| Original Enrollment ICMJE | 557 | |||
| Actual Study Completion Date ICMJE | December 2003 | |||
| Actual Primary Completion Date | December 2003 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Other inclusion applies Exclusion Criteria:
Other exclusion applies. | |||
| 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 | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00228410 | |||
| Other Study ID Numbers ICMJE | 3074A1-305 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| 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 | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||