CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 37 enrolled / 37 target
Drug / intervention
Delamanid +1 moredrug
Likely dose
Delamanid 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03141060
NCT03141060Phase 1CompletedUpdate Overdue (0.4/mo)Completion was 14mo ago
CompareCT.gov

A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 4, 2017·Updated Jun 25, 2026

In Brief

A Phase 1 clinical trial evaluating Delamanid and Optimized multidrug background regimen (OBR) for children with MDR-TB for Tuberculosis and HIV Infections. Completed, enrolled 37 participants across 5 sites in 3 countries.

Signals

Enrollment appears stalled

Detailed Summary

This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant tuberculosis (MDR-TB) in children with MDR-TB with and without HIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, HIV Infections
CountriesIndia, South Africa, Tanzania
CollaboratorsOtsuka Pharmaceutical Development & Commercialization, Inc.

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 4, 2017
Enrollment StartFeb 18, 2019
Primary CompletionApr 22, 2025
Study CompletionMay 29, 2025
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 9.2 years ago

Arms & Interventions

Cohort 1 (>=12 to < 18 years)experimental

Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB.

Drug: DelamanidDrug: Optimized multidrug background regimen (OBR) for children with MDR-TB
Cohort 2 (>=6 to < 12 years)experimental

Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB.

Drug: DelamanidDrug: Optimized multidrug background regimen (OBR) for children with MDR-TB
Cohort 3 (>=3 to < 6 years)experimental

Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB.

Drug: DelamanidDrug: Optimized multidrug background regimen (OBR) for children with MDR-TB
Cohort 4 (>=0 to < 3 years)experimental

Participants received delamanid (DLM) twice daily for 24 weeks. Participants also received non-study prescribed OBR for MDR-TB.

Drug: DelamanidDrug: Optimized multidrug background regimen (OBR) for children with MDR-TB

Interventions

Delamaniddrug

Administered orally; dosing based on participants' weight. ≥ 40 kg: 100 mg twice daily (adult formulation); 30 to \< 40 kg: 50 mg twice daily (adult formulation); 15 to \< 30 kg: 25 mg twice daily (pediatric formulation); \< 15 kg: 15 mg twice daily (pediatric formulation)

Optimized multidrug background regimen (OBR) for children with MDR-TBdrug

Non-study prescribed OBR varied according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks.