Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI

NCT00488761

Last updated date
Study Location
Multiple Cities, , , Taiwan
Contact
1-800-718-1021

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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

- Hospitalized male and female patients, 18 years of age or older.

- Anticipated need for intravenous antibiotic therapy of 5 days or longer.

- Patients known or suspected to have a complicated skin and skin structure infection.

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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI
Official Title  ICMJE A Multicenter, Open Label Study to Evaluate the Safety and Efficacy of Tigecycline to Treat Complicated Skin and Skin Structure Infections (cSSSI) in Hospitalized Patients
Brief Summary Tigecycline's activity against resistant organisms, as well as significant coverage of both gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in treating patients with complicated skin and/or skin structure infections.
Detailed Description To evaluate the safety and the efficacy of tigecycline in treating hospitalized patients with complicated skin and/or skin structure infections.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Skin Diseases, Infectious
Intervention  ICMJE Drug: Tigecycline
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: June 18, 2007)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hospitalized male and female patients, 18 years of age or older.
  • Anticipated need for intravenous antibiotic therapy of 5 days or longer.
  • Patients known or suspected to have a complicated skin and skin structure infection.

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.
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 Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00488761
Other Study ID Numbers  ICMJE 101993
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
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
Principal Investigator:Trial ManagerFor Taiwan, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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