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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00228410
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Primary Completion Date : December 2003
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 Measures :
  1. Safety assessments included a physical examination and daily recording of vital signs (temperature, heart rate, blood pressure).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00228410     History of Changes
Other Study ID Numbers: 3074A1-305
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Skin Infections
Skin Disease

Additional relevant MeSH terms:
Infection
Skin Diseases
Communicable Diseases
Skin Diseases, Infectious
Vancomycin
Tigecycline
Minocycline
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents