EUCTR2005-003312-29-ES进行中（未招募）不适用
Evaluation of a Moxifloxacin-Based, Isoniazid-Sparing Regimen for Tuberculosis Treatment TBTC/UITB Study 28 - Moxifloxacin for Isoniazid
TB Investigation Unit of Barcelona0 个研究点目标入组 410 人开始时间: 2006年2月16日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 410
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Suspected pulmonary tuberculosis with acid-fast bacilli in a stained sputum smear. Patients whose sputum cultures do not grow M. tuberculosis, and those having an M. tuberculosis isolate resistant to isoniazid, rifampin, fluoroquinolones, or any 2 study drugs will be discontinued from the study, but followed for 14 days to detect late toxicities from study therapy. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment.
- •2. Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 6 months prior to enrollment
- •3. 14 or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding enrollment
- •4. 10 or fewer days of treatment with a fluoroquinolone during the 3 months preceding enrollment
- •5. Age > 18 years
- •6. Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs)
- •7. Signed informed consent
- •8. Women with child bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy.
- •9. Laboratory parameters done at, or < 14 days prior to, screening:
- •? Serum amino aspartate transferase (AST) activity = 3 times the upper limit of normal
- •? Serum total bilirubin level = 2.5 times the upper limit of normal
- •? Serum creatinine level = 2 times the upper limit of normal
- •? Complete blood count with hemoglobin level of at least 7.0 g/dL
- •? Complete blood count with platelet count of at least 50,000/mm3
- •? Serum potassium > 3.0 meq/L
- •? Negative pregnancy test (for women of childbearing potential)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Breast-feeding
- •2. Known intolerance to any of the study drugs
- •3. Known allergy to any fluoroquinolone antibiotic
- •4. Concomitant disorders or conditions for which moxifloxacin, isoniazid, rifampin, pyrazinamide, or ethambutol are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gout.
- •5. Current or planned therapy during the intensive phase of tuberculosis treatment using drugs having unacceptable interactions with rifampin (rifabutin can be substituted for rifampin during the continuation phase of therapy)
- •6. Current or planned antiretroviral therapy during the intensive phase of tuberculosis treatment
- •7. History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during the intensive phase of tuberculosis treatment.
- •8. Pulmonary silicosis
- •9. Central nervous system TB
研究者
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