CompletedPhase 1/2

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

India, South Africa, Tanzania37 participantsStarted 2019-02-18

Plain-language 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.

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Peripheral TB lymphadenitis
. Pleural effusion or fibrotic pleural lesions
. Stage 1 TB meningitis
. Miliary and abdominal TB

Exclusion criteria

. Peripheral TB lymphadenitis
. Pleural effusion or fibrotic pleural lesions
. Stage 1 TB meningitis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Adverse Events of ≥ Grade 3 Severity

Timeframe: Measured from entry through Week 24

Percentage of Participants With Adverse Events of ≥ Grade 3 Assessed by the Core Team to be at Least Possibly Related to the Study Drug

Timeframe: Measured from entry through Week 24

Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event

Timeframe: Measured from entry through Week 24

Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec

Timeframe: Entry, weeks 2, 8, 12, 16, 20, and 24

Percentage of Participants Who Died Through Week 24

Timeframe: Measured from entry through Week 24

Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h) DLM

Timeframe: Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose

Trial details

NCT IDNCT03141060

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-04-22

Results submitted2026-04-17

View on ClinicalTrials.gov More Tuberculosis trials

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Peripheral TB lymphadenitis
. Pleural effusion or fibrotic pleural lesions
. Stage 1 TB meningitis
. Miliary and abdominal TB

Exclusion criteria

. Peripheral TB lymphadenitis
. Pleural effusion or fibrotic pleural lesions
. Stage 1 TB meningitis

What they're measuring

Percentage of Participants With Adverse Events of ≥ Grade 3 Severity

Timeframe: Measured from entry through Week 24

Percentage of Participants With Adverse Events of ≥ Grade 3 Assessed by the Core Team to be at Least Possibly Related to the Study Drug

Timeframe: Measured from entry through Week 24

Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event

Timeframe: Measured from entry through Week 24

Percentage of Participants With Absolute Corrected QT Interval by Fridericia (QTcF) ≥ 500 Msec

Timeframe: Entry, weeks 2, 8, 12, 16, 20, and 24

Percentage of Participants Who Died Through Week 24

Timeframe: Measured from entry through Week 24

Geometric Mean of Area Under the Concentration Versus Time Curve (AUC0-24h) DLM

Timeframe: Approximately day 10 (Week 2) at pre-dose, and 2, 4, and hours post dose