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Trial record 1 of 1 for:    NCT00488306
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Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI

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ClinicalTrials.gov Identifier: NCT00488306
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : July 7, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE June 18, 2007
First Posted Date  ICMJE June 20, 2007
Last Update Posted Date July 7, 2009
Study Start Date  ICMJE August 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2007)
The primary efficacy endpoint will be clinical response within the clinically evaluable population at the test-of-cure assessment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00488306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2007)
microbiological response (eradicated, persistence, superinfection, or indeterminate) at the patient level, microbiological response (eradicated, persistence, or indeterminate) at the pathogen level (overall and resistant pathogens) clinical
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI
Official Title  ICMJE A Multicenter, Open Label Study to Evaluate the Efficacy and Safety of Tigecycline to Treat Complicated Intra-Abdominal Infections (cIAI) in Hospitalized Patients
Brief Summary In light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.
Detailed Description To evaluate the efficacy and safety of tigecycline to treat complicated intra-abdominal infections in hospitalized patients. Both the clinical response profile and the microbiological response profile will be assessed. The primary endpoint will be clinical response within the microbiological evaluable population at the test-of-cure assessment.
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 Abdominal Abscess
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 or female patients greater than or equal to 18 years of age.
  • Patients must be a candidate for or have had a laparotomy, or laparoscopy of an intra-abdominal abscess.
  • Patients with a complicated intra-abdominal infection such as:

    • an intra-abdominal abscess;
    • an intra-abdominal abscess (including liver and spleen) that develops in a post-operative patient after receiving > 48 hours and less than or equal to 5 days of a non-study antibiotic. An intra-abdominal culture must be obtained from the infected site.
    • appendicitis complicated by perforation (grossly visible) and abscess and/or periappendiceal abscess;
    • perforated diverticulitis complicated by abscess formation or fecal contamination;
    • complicated cholecystitis with evidence of perforation or empyema;
    • perforation of the large or small intestine with abscess, or fecal contamination;
    • purulent peritonitis or peritonitis associated with fecal contamination;
    • gastric or duodenal ulcer perforation with symptoms lasting at least 24 hours prior to operation;
    • traumatic bowel perforation with symptoms lasting at least 12 hours prior to operation.

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 or follow-up visits could be completed.
  • Active or treated leukemia or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the past 3 months, or any metastatic malignancy to the abdomen with life expectancy less than 6 months.
  • Anticipated length of antibiotic therapy less than 5 days.
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 NCT00488306
Other Study ID Numbers  ICMJE 3074A1-101994
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 Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Taiwan, medinfo@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

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