Status:
COMPLETED
Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Bacterial Infections
Eligibility:
All Genders
8+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations. The secondary objective is to evaluate the safety and efficacy of tige...
Eligibility Criteria
Inclusion
- Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.
- Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.
- Patient must give informed consent.
Exclusion
- Patients with an expected survival of less than 2 weeks.
- Patients who have been designated as "Do Not Resuscitate".
- Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents.
- Pregnant women or nursing mothers.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00205816
Start Date
January 1 2004
End Date
November 1 2005
Last Update
February 8 2013
Active Locations (3)
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1
Heidelberg, Germany, D-69120
2
Gdansk, Poland, 80-952
3
Poznan, Poland, 60-355