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

Condition(s) targeted: Tuberculosis, Pulmonary

Intervention: Levofloxacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Marina Atarshchikova, Study Director, Affiliation: Sanofi-Aventis

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.

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Number of patients with bacterioexcretion

Dynamics of chest radiograph

Dynamics of Intoxication

All clinical and laboratory adverse events

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Sanofi-Aventis, Moscow, Russian Federation

Starting date: June 2007
Last updated: June 3, 2008