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

Primary Purpose

Abdominal Abscess

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
tigecycline
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Abscess focused on measuring Tigecycline, Complicated intra-abdominal infections, cIAI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2007
Last Updated
July 6, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00488306
Brief Title
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Abscess
Keywords
Tigecycline, Complicated intra-abdominal infections, cIAI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tigecycline
Primary Outcome Measure Information:
Title
The primary efficacy endpoint will be clinical response within the clinically evaluable population at the test-of-cure assessment.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Taiwan, medinfo@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Multiple Cities
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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