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

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)

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 Overview

• Status: Completed
• Conditions: Tuberculosis, Pulmonary
• Intervention / Treatment: Drug: Levofloxacin

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Levofloxacin	Drug: Levofloxacin; 500-1000 mg once a day daily per os with combination of drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with bacterioexcretion	1 month, 2 months, 3 months
Dynamics of chest radiograph	3 months
Dynamics of Intoxication	1 month, 2 months, 3 months
All clinical and laboratory adverse events	from the signature of the Informed Concent Form (ICF) up to the end of the study

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Marina Atarshchikova, Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: July 2, 2007
• First Submitted That Met QC Criteria: July 2, 2007
• First Posted (Estimate): July 3, 2007

Study Record Updates

• Last Update Posted (Estimate): March 4, 2009
• Last Update Submitted That Met QC Criteria: March 3, 2009
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: LEVOF_L_00972

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No