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)”

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 Type: Interventional

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

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Levofloxacin
  • 500-1000 mg once a day daily per os with combination of drugs.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Levofloxacin

Primary Measures

• Number of patients with bacterioexcretion
  • Time Frame: 1 month, 2 months, 3 months
    Safety Issue?: No
• Dynamics of chest radiograph
  • Time Frame: 3 months
    Safety Issue?: No
• Dynamics of Intoxication
  • Time Frame: 1 month, 2 months, 3 months
    Safety Issue?: No
• All clinical and laboratory adverse events
  • Time Frame: from the signature of the Informed Concent Form (ICF) up to the end of the study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Marina Atarshchikova Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00495339

Study ID Number: LEVOF_L_00972

ClinicalTrials.gov Identifier: NCT00495339

Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation