MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
- Registration Number
- NCT00495339
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Levofloxacin Levofloxacin
- Primary Outcome Measures
Name Time Method Number of patients with bacterioexcretion 1 month, 2 months, 3 months Dynamics of Intoxication 1 month, 2 months, 3 months Dynamics of chest radiograph 3 months All clinical and laboratory adverse events from the signature of the Informed Concent Form (ICF) up to the end of the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis
🇷🇺Moscow, Russian Federation