We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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

Brief Summary:
In light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.

Condition or disease Intervention/treatment Phase
Abdominal Abscess Drug: tigecycline Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label Study to Evaluate the Efficacy and Safety of Tigecycline to Treat Complicated Intra-Abdominal Infections (cIAI) in Hospitalized Patients
Study Start Date : August 2006
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess
Drug Information available for: Tigecycline
U.S. FDA Resources

Primary Outcome Measures :
  1. The primary efficacy endpoint will be clinical response within the clinically evaluable population at the test-of-cure assessment.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488306

Multiple Cities, Taiwan
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Taiwan, medinfo@wyeth.com

ClinicalTrials.gov Identifier: NCT00488306     History of Changes
Other Study ID Numbers: 3074A1-101994
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Complicated intra-abdominal infections

Additional relevant MeSH terms:
Intraabdominal Infections
Abdominal Abscess
Anti-Bacterial Agents
Anti-Infective Agents