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

Sanofi100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Tuberculosis, Pulmonary

Interventions

LevofloxacinDRUG

500-1000 mg once a day daily per os with combination of drugs.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Moscow, Russia

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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