NCT03141060View on ClinicalTrials.gov

Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-Infected and HIV-Uninfected Children With MDR-TB

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

January 30, 2018

Primary Completion Date

April 22, 2025

Study Completion Date

May 29, 2025

Conditions
TuberculosisHIV Infections
Interventions
DRUG

Delamanid

Administered orally; dosing will be based on participants' age and weight.

DRUG

Optimized multidrug background regimen (OBR) for children with 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 DLM for 24 weeks.

Trial Locations (5)

2574

PHRU Matlosana CRS, Klerksdorp

7505

Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town

411001

Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune

Unknown

Sizwe CRS, Johannesburg

Kilimanjaro Christian Medical Centre (KCMC), Moshi

All Listed Sponsors
collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03141060 - Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-Infected and HIV-Uninfected Children With MDR-TB | Biotech Hunter | Biotech Hunter