MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
This study has been completed.
Information provided by:
First received: July 2, 2007
Last updated: March 3, 2009
Last verified: June 2008
Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB.
Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Open Non-Comparative Clinical Study to Evaluate the Efficacy and Safety of Three Months TAVANIC Course (Levofloxacin) in Combine Treatment of Multi-Drug-Resistant Tuberculosis (MDR-TB)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Number of patients with bacterioexcretion [ Time Frame: 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
- Dynamics of chest radiograph [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Dynamics of Intoxication [ Time Frame: 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
- All clinical and laboratory adverse events [ Time Frame: from the signature of the Informed Concent Form (ICF) up to the end of the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
500-1000 mg once a day daily per os with combination of drugs.
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