ISRCTN92634082CompletedPhase 3
A phase III cluster randomised placebo-controlled trial to assess the efficacy of preventive therapy in child and adolescent contacts of multidrug-resistant (MDR) tuberculosis (TB)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Stellenbosch University
- Enrollment
- 922
Study Overview
Brief Summary
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30572905 protocol
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current inclusion criteria as of 17/08/2022:
- •1. Child or adolescent aged <18 years who is a household contact of an adult MDR-TB index case (as stated under adult MDR-TB eligibility criteria). The eligibility criteria would be including diagnosis in the previous 6 months. If =5 years and <18 years of age, the child/adolescent must have a positive IGRA test before enrolment unless HIV positive.
- •2. Primary residence in the household of the adult MDR-TB index case
- •3. Consent from the parent or legal guardian for the child for HIV testing (HIV-infected and uninfected children will be included)
- •4. Consent obtained from the parent or legal guardian for the child to be enrolled
- •Previous inclusion criteria:
- •1. Child <5 years who is a household contact of an enrolled adult MDR-TB index case diagnosed during the previous 6 months
- •2. Primary residence in the household of the adult MDR-TB index case
- •3. Consent from the parent or legal guardian for the child for HIV testing (HIV-infected and uninfected children will be included)
- •4. Consent obtained from the parent or legal guardian for the child to be enrolled
Exclusion Criteria
- •1. TB disease at enrolment
- •2. Currently on INH or a FQN (e.g. LFX, MFX, ofloxacin or ciprofloxacin) for =14 days
- •3. Treated for TB in the previous 12 months
- •4. Known concurrent exposure to an INH-susceptible (including RIF-monoresistant) index case
- •5. Children with myasthenia gravis or Guillain-Barré syndrome
Investigators
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