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)
NCT number | NCT00495339 |
Other study ID # | LEVOF_L_00972 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | July 2, 2007 |
Last updated | March 3, 2009 |
Start date | June 2007 |
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 |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | Sanofi-Aventis | Moscow |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Russian Federation,
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 |
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