Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections
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|ClinicalTrials.gov Identifier: NCT00228410|
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : February 8, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Skin Diseases, Infectious||Drug: Tigecycline Drug: vancomycin with aztreonam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||503 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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.|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||December 2003|
|Actual Study Completion Date :||December 2003|
- The primary efficacy endpoint was the clinical response in the co-primary populations of the clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) subjects at the test-of-cure assessment.
- Safety assessments included a physical examination and daily recording of vital signs (temperature, heart rate, blood pressure).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228410
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|
|Responsible Party:||Wyeth is now a wholly owned subsidiary of Pfizer|
|Other Study ID Numbers:||
|First Posted:||September 28, 2005 Key Record Dates|
|Last Update Posted:||February 8, 2013|
|Last Verified:||February 2013|
Skin Diseases, Infectious
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action