Completed

A Multicenter, Double-Blind, Randomized Comparison Study Of the Efficacy and Safety of Tigecycline to Imipenem/ Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects

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What is being tested

Data Collection

Who is being recruted

Bacterial Infections and Mycoses
+7

+ Bacterial Infections
+ Communicable Diseases
Over 8 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2002
See protocol details

Summary

Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2002Actual date on which the first participant was enrolled.

Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

Official TitleA Multicenter, Double-Blind, Randomized Comparison Study Of the Efficacy and Safety of Tigecycline to Imipenem/ Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects 
NCT00081744
Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
850 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 8 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bacterial Infections and Mycoses
Bacterial Infections
Communicable Diseases
Cross Infection
Iatrogenic Disease
Infections
Pathologic Processes
Gram-Positive Bacterial Infections
Disease Attributes
Intraabdominal Infections
Criteria

Inclusion Criteria: * Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms * Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline * Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics Exclusion Criteria: * Subjects who are moribund with an expected survival of less than 2 weeks. * Subjects who have been designated as "Do Not Resuscitate", unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy * Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers
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