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

Tuberculosis, Pulmonary Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00495339
• Other study ID #: LEVOF_L_00972
• Status: Completed
• Phase: Phase 4
• First received: July 2, 2007
• Last updated: March 3, 2009
• Start date: June 2007

Study information

• Verified date: June 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Multidrug-Resistant
• Tuberculosis, Pulmonary

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Sanofi-Aventis	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with bacterioexcretion		1 month, 2 months, 3 months	No
Primary	Dynamics of chest radiograph		3 months	No
Primary	Dynamics of Intoxication		1 month, 2 months, 3 months	No
Primary	All clinical and laboratory adverse events		from the signature of the Informed Concent Form (ICF) up to the end of the study	Yes