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Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin Diseases, Infectious

Intervention: Tigecycline (Drug); vancomycin with aztreonam (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Safety assessments included a physical examination and daily recording of vital signs (temperature, heart rate, blood pressure).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 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.

- Necrotizing fasciitis or gangrene.

Other exclusion applies.

Locations and Contacts

Additional Information

Starting date: November 2002
Last updated: February 7, 2013

Page last updated: August 23, 2015

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