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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Tuberculosis, Pulmonary

Treatments: Drug: Levofloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00495339

LEVOF_L_00972

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

1

Experimental group

Description:

Levofloxacin

Treatment:

Drug: Levofloxacin