None listed
Conditions
Interventions
Enrolled participants will receive 250 mg tablets of Levofloxacin orally and will be randomized to doses of 11 mg/kg, 14 mg/kg, 17 mg/kg and 20 mg/kg which are the equivalent for their weight to 750mg
Sponsors
UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with smear-positive, culture positive* pulmonary TB 2. sputum contains isoniazid* and rifampin-resistant, Ofloxacin-susceptible MTB, all by MTBDR-sl 3. Previously treated or newly diagnosed with tuberculosis 4. 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. 5. Age ≥ 18 years. 6. Weight > 40 Kg 7. Karnofsky score of > 60 (see section 18.1) 8. Willingness by the patient to attend scheduled follow-up visits and undergo study assessments. 9. Women with child-bearing potential must agree to practice an adequate barrier method of birth control or to abstain from heterosexual intercourse during study regimen. 10. Laboratory parameters (performed within 14 days prior to enrollment): • Estimated Serum creatinine clearance should be 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 11. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Currently breast-feeding or pregnant. 2. Known allergy or intolerance to or toxicity from fluoroquinolones or other medications utilized in this study. 3. In the judgment of the physician the patient is not expected to survive for 6 months 4. Anticipated surgical intervention for the treatment of pulmonary tuberculosis 5. Participation in another investigational drug trial within the past 30 days 6. 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 7. Poorly controlled diabetes 8. known g-6-phosphate dehydrogenase deficiency 9. Use of quinolone for 7 days within past 30 days 10. QTc interval greater than 450 msec for men or greater than 470 msec for women
Countries
Peru, South Africa
Contacts
Public ContactCarlos Zamudio
UNIVERSIDAD PERUANA CAYETANO HEREDIA
Outcome results
None listed