ISRCTN26467068进行中（未招募）2 期
Pilot Phase II trial to optimise pharmacometric assessments in Chagas disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult volunteers with chronic T. cruzi infection, a blood-stage parasite density of at least 2 parasite equivalents per mL, with or without end-organ involvement and:
- •1.1. Participant is willing and able to give informed consent for participation in the study.
- •1.2. Adult patients, male or female, aged over 18 years and less than 99 years.
- •1.3. Lives in the Belo Horizonte metropolitan area and can comply with study procedures.
- •1.4. Circulating parasitaemia greater or equal to 2 parasites equivalent per mL.
排除标准
- •1. Has received prior treatment with benznidazole, nifurtimox or posaconazole (either completely or incompletely).
- •2. History of hypersensitivity, allergic, or serious adverse reactions to any nitroimidazole compound, posaconazole and/or its components.
- •3. Inability to attend follow-up visits on the stipulated dates.
- •4. Acute or chronic health problems that, in the opinion of the principal investigator, may interfere with study completion.
- •5. Alcohol or drug dependence.
- •6. HIV infection or is immunocompromised.
- •7. Pregnant or breastfeeding.
- •8. Patients taking any immunosuppressant drugs.
- •9. QT prolongation (>450 ms for males; >470 ms for females).
- •10. Basic laboratory parameters outside the normal range or that are considered clinically relevant by the physician responsible for the patient.
- •10.1. Total white blood cell counts outside the normal range, as defined by an acceptable margin of +/- 5% (3,800 - 10,500 / mm3);
- •10.2. Transaminases (ALT and AST) outside the normal range, as defined by 25% above the upper limit of normal (ULN, > 1.25 x ULN).
- •11. Therapy with drugs metabolized by CYP3A4, such as terfenadine, astemizole, pimozide, halofantrine or quinidine, and HMG-CoA reductase inhibitors (simvastatin, lovastatin, and atorvastatin).
- •12. Patients receiving treatment with proton pump inhibitors or H2 receptor antagonists, phenytoin, efavirenz, and rifabutin, or who cannot discontinue it during the study period.
- •13. Patients receiving any drugs known to prolong the QT interval significantly.
研究者
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