MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
|ClinicalTrials.gov Identifier: NCT00495339|
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : March 4, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis, Pulmonary||Drug: Levofloxacin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||June 2007|
|Primary Completion Date :||April 2008|
500-1000 mg once a day daily per os with combination of drugs.
- Number of patients with bacterioexcretion [ Time Frame: 1 month, 2 months, 3 months ]
- Dynamics of chest radiograph [ Time Frame: 3 months ]
- Dynamics of Intoxication [ Time Frame: 1 month, 2 months, 3 months ]
- All clinical and laboratory adverse events [ Time Frame: from the signature of the Informed Concent Form (ICF) up to the end of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495339
|Moscow, Russian Federation|
|Study Director:||Marina Atarshchikova||Sanofi|