Clofazimine and moxifloxacin PK, safety, and AccepTAbiLitY for paediatric TB treatment (CATALYST)

Not Applicable

• Conditions: Tuberculosis

• Registration Number: PACTR202012756409365
• Lead Sponsor: Stellenbosch University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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
AND
-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);
AND
-Rifampicin resistance demonstrated by genotypic (molecular) or phenotypic methods;
AND
-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
AND
-Documented exposure to a source case with bacteriologically confirmed intrathoracic, rifampicin-resistant TB*;
AND
-A clinical decision has been made to treat the child for RR-TB

A TB source case with microbiologically confirmed intrathoracic TB is defined as a person (case) with intrathoracic TB, with or without extrapulmonary TB, with 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 with rifampicin drug resistance demonstrated by genotypic (molecular) or phenotypic methods, who is suspected to be responsible for transmitting M. tuberculosis to the potential participant. Documentation of source case details is expected to be available in the child’s medical records and relevant eligibility criteria will be based on review of the child’s medical records only

3.Routinely treated with both clofazimine and a fluoroquinolone as part of a RR-TB treatment regimen and on treatment for <16 weeks
4.HIV-infected

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified