Tuberculosis child and adolescent multidrug-resistant preventive therapy: TB CHAMP trial

Phase 3

Completed

• Conditions: Multi drug resistant tuberculosis (MDR-TB); Infections and Infestations

• Registration Number: ISRCTN92634082
• Lead Sponsor: Stellenbosch University

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30572905 protocol

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-28
• Study Completion: 2023-02-28
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 922

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified