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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Levofloxacin; Ofloxacin

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.