The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB) (index cases). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
INDEX CASE
* Men and women age greater than or equal to 18 years.
* Pulmonary MDR-TB defined as:
* Confirmation of rifampin/rifampicin (RIF) resistance and INH resistance by
* adequate source documentation (including date of testing, test methodology, and test results) of RIF and INH resistance from a licensed/nationally approved\* referral program, OR
* if either or both results are unknown or not adequately documented (as noted above), then confirmation must be obtained using a DAIDS-approved laboratory that operates according to Good Clinical Laboratory Practices (GCLP) guidelines and participates in an appropriate external quality assurance (EQA) program.
* \*NOTE: The term "licensed/nationally approved" refers to a laboratory that has been certified or licensed by an oversight body within that country and approved for RIF and/or INH resistance testing.
* NOTE: Pre-XDR and XDR TB are not exclusionary. See the A5300B/I2003B/PHOENIx MOPS for study-approved molecular and phenotypic methods.
* Started MDR-TB treatment within the past 90 days.
* Ability and willingness of the index case to provide informed consent to access the HH and approach HH members for evaluation.
* HH of index case has at least one reported HHC.
HOUSEHOLD CONTACTS
If any member(s) of the HH is/are not eligible or do not want to participate, all other eligible TB contacts within the HH can still participate.
* Currently lives or lived in the same dwelling unit or plot …
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
1
Percent of participants with confirmed or probable active TB at any time between Day 0 and the week 96 study visit
Timeframe: Measured through Week 96
2
Percent of participants who permanently discontinue randomized study drug (DLM or INH) due to a treatment-related adverse event
Timeframe: Measured through Week 96
Trial details
NCT IDNCT03568383
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)