MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis, Pulmonary
Intervention: Levofloxacin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Marina Atarshchikova, Study Director, Affiliation: Sanofi
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.
Clinical Details
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)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of patients with bacterioexcretionDynamics of chest radiograph Dynamics of Intoxication All clinical and laboratory adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sanofi-Aventis, Moscow, Russian Federation
Additional Information
Starting date: June 2007
Last updated: March 3, 2009
|