Tuberculosis, Pulmonary
Conditions
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.
Interventions
DRUGLevofloxacin
500-1000 mg once a day daily per os with combination of drugs.
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with bacterioexcretion | 1 month, 2 months, 3 months |
| Dynamics of chest radiograph | 3 months |
| Dynamics of Intoxication | 1 month, 2 months, 3 months |
| All clinical and laboratory adverse events | from the signature of the Informed Concent Form (ICF) up to the end of the study |
Countries
Russia
Outcome results
None listed