MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis

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)

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.

Inclusion Criteria:

• Drug-resistant pulmonary tuberculosis laboratory diagnosed

Exclusion Criteria:

• Known hypersensitivity to levofloxacin, other quinolones
• Patient with epilepsy and central nervous system diseases
• Renal insufficiency with serum creatinine lower than 50 ml/min
• Arterial hypertension, ischemic heart disease in acute phase
• Gastro-intestinal diseases, liver diseases in acute phase
• History of drug and alcohol abuse
• Patient with history of tendon disorders related to fluoroquinolone administration
• Pregnancy and breast-feeding women
• Immune system disorders related to chemotherapy, AIDS, long term administration of corticosteroids

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.