A phase I/II trial of the pharmacokinetics, safety, tolerability and acceptability of new formulations of clofazimine and moxifloxacin in children treated for rifampicin-resistant tuberculosis - CATALYST

Stellenbosch University0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Confirmed or clinically diagnosed pulmonary or extrapulmonary RR-TB
•2. Routinely treated with both clofazimine and a fluoroquinolone as part of a RR-TB treatment regimen and on treatment for <16 weeks
•3. HIV-infected and -uninfected
•4. Written informed consent (and assent in older children)

•1. Hemoglobin <8.0 g/dL at the time of enrolment
•2. ALT > 5X the upper limit of normal (ULN) at the time of enrolment 3. Body weight <5 kg at the time of enrolment
•4. QTcF >460 ms (value of QT interval, corrected using Fridericaâ??s method) on ECG during screening, history of familial long QT syndrome, or any other clinically significant cardiac or ECG abnormality that the investigator deems may be a risk for QT prolongation
•Note: Participants must be enrolled into the study based on final ECG readings by the protocol cardiologist. The site investigator should also evaluate the ECG and document that assessment in the source documentation and manage the participant clinically in real time based on the local reading
•5. Known intolerance or hypersensitivity to moxifloxacin or clofazimine
•6. A condition such as clinically significant cardiac, renal, liver, neurological, neuropsyschological or any other condition that in the opinion of the site
•7. Use, or anticipated use, of any of the prohibited medications (see Section 5.7) within 3 days of enrolment

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