The pharmacokinetics, safety and acceptability of new child-friendly formulations of clofazimine and moxifloxacin in children routinely treated for rifampicin-resistant (RR-TB) tuberculosis.

Stellenbosch University0 sites36 target enrollmentAugust 28, 2020

Overview

No summary available.

Registry

who.int

Start Date

August 28, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.0 to \<15 years of age
•2\.Confirmed or clinically diagnosed pulmonary or extrapulmonary RR\-TB
•Confirmed with RR\-TB
•\-A diagnosis of TB based on a combination of the presence of symptoms consistent with TB (pulmonary or extrapulmonary) and/or a chest radiograph (or other radiological investigation) considered suggestive of TB
•\-Microbiological confirmation of M. tuberculosis from any clinical specimen by either culture or molecular methods (including Xpert MTB/RIF or Xpert MTB/RIF Ultra and/or other approved molecular tests);
•\-Rifampicin resistance demonstrated by genotypic (molecular) or phenotypic methods;
•\-A clinical decision has been made to treat the child for RR\-TB
•Clinically diagnosed with RR\-TB
•\-A presumptive diagnosis of TB based on a combination of the presence of symptoms consistent with TB (pulmonary or extrapulmonary) and/or a chest radiograph (or other radiological investigation) considered suggestive of TB
•\-Documented exposure to a source case with bacteriologically confirmed intrathoracic, rifampicin\-resistant TB\*;

•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 \<2\.5 kg at the time of enrolment
•4\.QTcF \>460 ms (corrected mean value of QT interval, corrected using Friderica’s method), 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 in real time based on the local read
•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 investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
•7\.Use, or anticipated use, of any of the prohibited medications (see Section 5\.7\) within 3 days of enrolment