PROSPECTIVE, RANDOMIZED, BLINDED PHASE 2 PHARMACOKINETIC/PHARMACODYNAMIC STUDY OF THE EFFICACY AND TOLERABILITY OF LEVOFLOXACIN IN COMBINATION WITH OPTIMIZED BACKGROUND REGIMEN (OBR) FOR THE TREATMENT OF MDR-TB

IVERSIDAD PERUANA CAYETANO HEREDIA,0 个研究点目标入组 63 人开始时间: 2014年6月26日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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 <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
•11.Able to provide informed consent

•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

发起方

IVERSIDAD PERUANA CAYETANO HEREDIA,