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

NCT00228410

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infectious Skin Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Infectious Skin DiseasesStudy Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections NCT00228410
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Advanced Information
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
  • Drug: Tigecycline
  • Drug: vancomycin with aztreonam
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
 (submitted: February 7, 2013)
503
Original Enrollment  ICMJE
 (submitted: September 26, 2005)
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:

  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
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