MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
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|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|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495339
|Moscow, Russian Federation|
|Study Director:||Marina Atarshchikova||Sanofi|