PACTR202008476090763已完成1 期
Evaluating the pharmacokinetics and acceptability of 100 mg dispersible compared to 250 mg non-dispersible tablets of levofloxacin in children with multidrug-resistant tuberculosis exposure
Stellenbosch University Tygerberg Hospital0 个研究点目标入组 24 人开始时间: 2020年7月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- 年龄范围
- 0 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1. HIV-uninfected
- •2. Age < 6 years at enrolment
- •3. Started on MDR-TB preventive therapy including levofloxacin by the routine TB program for significant exposure to an MDR-TB source case
- •4. Receiving levofloxacin for at least 14 days prior to enrolment
- •5. Written informed consent including for HIV testing if HIV status is unknown
排除标准
- •1. TB disease
- •2. HIV infection
- •3. Laboratory-documented anaemia (Hb <8 g/dl) (enrollment may be deferred until anaemia improves)
- •4. Body weight <3 kg (enrollment may be deferred until weight increases) and = 30 kg
- •5. Serious chronic illness, such as clinically significant structural cardiac disease, chronic lung, renal or liver disease
- •6. Known hypersensitivity or intolerance to levofloxacin
- •7. Grade 2 or higher abnormality of any of the following at the time of screening or known within 14 days prior to enrollment, according to the DAIDS Table of Grading Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017(3): ALT, total bilirubin, or creatinine.
- •8. Total bilirubin 1.5 X the upper limit of normal accompanied by Grade 2 or higher elevated ALT
研究者
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