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

NCT ID: NCT00488306

Last Updated: 2009-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-08-31

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.

Conditions

Abdominal Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

tigecycline

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Taiwan, medinfo@wyeth.com

Locations

Multiple Cities, , Taiwan

Countries

Taiwan

Other Identifiers

3074A1-101994

Identifier Type: -

Identifier Source: org_study_id