NCT05586230View on ClinicalTrials.gov

Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

PHASE1RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

October 3, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
TuberculosisRifampicin Resistant Tuberculosis
Interventions
DRUG

Pretomanid

Administered orally based on participant's weight

DRUG

Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)

Non-study prescribed OBR will vary according to local, national and/or international guidelines for treatment of children with MDR-TB. Administered in addition to single dose of Pa.

Trial Locations (6)

2574

ACTIVE_NOT_RECRUITING

Site 31976, PHRU Matlosana CRS, Klerksdorp

Unknown

RECRUITING

Site 5071, Instituto de Puericultura e Pediatria Martagao Gesteira CRS, Rio de Janeiro

NOT_YET_RECRUITING

Site 31441, BJMC CRS, Pune

ACTIVE_NOT_RECRUITING

Site 31790, Desmond Tutu TB Centre (DTTC) CRS, Cape Town

ACTIVE_NOT_RECRUITING

Site 31929, Sizwe CRS, Johannesburg

RECRUITING

Site 5115, Siriraj Hospital, Mahidol University NICHD CRS, Bangkok Noi

All Listed Sponsors
collaborator

Global Alliance for TB Drug Development

OTHER

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH