Status:
COMPLETED
Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Gram-Positive Bacterial Infections
Cross Infection
Eligibility:
All Genders
8+ years
Phase:
PHASE3
Brief Summary
Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT00081744
Start Date
November 1 2002
End Date
August 1 2004
Last Update
February 8 2013
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