Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.
Phase 3
Completed
- Conditions
- Bacterial Infections
- Registration Number
- NCT00205816
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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 tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method response
- Secondary Outcome Measures
Name Time Method development of decreased susceptibility micro response at subject level micro response at pathogen level clinical response at pathogen level