Status:
COMPLETED
Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB
Lead Sponsor:
Boston University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Centers for Disease Control and Prevention
Conditions:
Tuberculosis, Multidrug-Resistant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around the world. This type of tuberculosis is very difficult to treat, and many patients die from it. Drugs of the ...
Detailed Description
MDR-TB is a growing threat to international health. A recent report from WHO estimated that over 440,000 new cases of MDR-TB occurred in 127 countries in 2008, causing 150,000 deaths; this represents ...
Eligibility Criteria
Inclusion
- Patients with smear-positive, culture positive\* pulmonary TB
- Sputum contains isoniazid\* and rifampin-resistant, Ofloxacin-susceptible MTB, all by MTBDR-sl
- Previously treated or newly diagnosed with tuberculosis
- Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 3 months prior to enrollment.
- Age ≥ 18 years.
- Weight \> 40 Kg
- Karnofsky score of \> 60 (see section 18.1)
- Willingness by the patient to attend scheduled follow-up visits and undergo study assessments.
- Women with child-bearing potential must agree to use birth control if you are having sex with men while participating in this study and for three months afterward.
- Laboratory parameters (performed within 14 days prior to enrollment):
- Estimated Serum creatinine clearance should be \<50, using nomogram78
- Hemoglobin concentration ≥ 9.0 g/dL
- Platelet count of ≥ 80,000/mm3
- Absolute neutrophil count (ANC) \> 1000/ mm3
- Negative pregnancy test (for women of childbearing potential) within 14 days of enrollment
- HIV viral load and CD4 count if HIV infected (within 3 months)
- Serum ALT and total bilirubin \<3 times upper limit of normal
- Able to provide informed consent
- Note: \*Subjects may be enrolled on the basis of a presumption that they will be culture positive at either screening or baseline if they are smear-positive, but they will be excluded from the analysis if cultures are subsequently negative. This will not be deemed a protocol violation. Similarly, subjects with rifampin susceptibility on a DNA-based test may be enrolled on the basis of a presumption that they will also be INH-resistant, but they will be excluded from the analysis if the isolate is subsequently shown to be INH-susceptible. This will also not be deemed a protocol violation.
Exclusion
- Currently breast-feeding or pregnant.
- Known allergy or intolerance to or toxicity from fluoroquinolones or other medications utilized in this study.
- In the judgment of the physician the patient is not expected to survive for 6 months
- Anticipated surgical intervention for the treatment of pulmonary tuberculosis
- Participation in another investigational drug trial within the past 30 days
- Concurrent use of known QT-prolonging drugs: a list of such medications can be found at http://www.azcert.org/medical-pros/drug-lists/printable-drug-list.cfm
- Poorly controlled diabetes
- Known g-6-phosphate dehydrogenase deficiency
- Use of quinolone for 7 days within past 30 days
- QTc interval greater than 450 msec for men or greater than 470 msec for women
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2022
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01918397
Start Date
January 1 2015
End Date
March 29 2022
Last Update
May 24 2023
Active Locations (3)
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1
Partners in Health
Lima, Peru
2
University of Cayetana Heredia
Lima, Peru
3
Stellenbosch University
Cape Town, South Africa