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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Tuberculosis, Pulmonary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Levofloxacin

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type DRUG

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

Interventions

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Levofloxacin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No