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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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.

NCT00228410
Pfizer
Completed
Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections

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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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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