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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00228410
First Posted: September 28, 2005
Last Update Posted: February 8, 2013
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.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
September 26, 2005
September 28, 2005
February 8, 2013
November 2002
December 2003   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00228410 on ClinicalTrials.gov Archive Site
Safety assessments included a physical examination and daily recording of vital signs (temperature, heart rate, blood pressure).
Same as current
Not Provided
Not Provided
 
Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Skin Diseases, Infectious
  • Drug: Tigecycline
  • Drug: vancomycin with aztreonam
Not Provided
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.
 
Completed
503
December 2003
December 2003   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00228410
3074A1-305
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP