Back to resultsMDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
Primary Purpose
Tuberculosis, Pulmonary
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Levofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis, Pulmonary
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Levofloxacin
Outcomes
Primary Outcome Measures
Number of patients with bacterioexcretion
Dynamics of chest radiograph
Dynamics of Intoxication
All clinical and laboratory adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00495339
Brief Title
MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
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 Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Levofloxacin
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
500-1000 mg once a day daily per os with combination of drugs.
Primary Outcome Measure Information:
Title
Number of patients with bacterioexcretion
Time Frame
1 month, 2 months, 3 months
Title
Dynamics of chest radiograph
Time Frame
3 months
Title
Dynamics of Intoxication
Time Frame
1 month, 2 months, 3 months
Title
All clinical and laboratory adverse events
Time Frame
from the signature of the Informed Concent Form (ICF) up to the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Atarshchikova
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
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