The study to determine whether the child friendly formulations for drug resistant tuberculosis are safe, tolerable and acceptable among children below 15 years of age.
- Conditions
- Health Condition 1: A199- Miliary tuberculosis, unspecifiedHealth Condition 2: A159- Respiratory tuberculosis unspecifiedHealth Condition 3: A188- Tuberculosis of other specified organs
- Registration Number
- CTRI/2020/09/027512
- Lead Sponsor
- Stellenbosch University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PKparameters (clearance,volume of distribution,and absorption-related parameters,and AUC, Cmax) of moxifloxacin and clofazimine in children with RR-TB, for the whole group and by age categories (0-2, 2-5and 5-12 years) and weight bands (above and below 15 kg) per formulation (i.e. PK sampling occasion).Timepoint: Measured through Week 24
- Secondary Outcome Measures
Name Time Method