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Evaluating 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

NCT03141060 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-06-25

Study results available
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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.

Conditions

Interventions

DRUG

Delamanid

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)

DRUG

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

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.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Anthony Garcia-Prats, MD · University of Wisconsin, Madison

  • Ethel Weld, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-18
Primary Completion
2025-04-22
Completion
2025-05-29
FDA Drug
Yes

Countries

  • India
  • South Africa
  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141060 on ClinicalTrials.gov