Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.|
- micro response at subject level
- micro response at pathogen level
- clinical response at pathogen level
- development of decreased susceptibility
|Study Start Date:||January 2004|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205816
|Heidelberg, Germany, D-69120|
|Gdansk, Poland, 80-952|
|Poznan, Poland, 60-355|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|