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)

Stellenbosch University0 sites922 target enrollmentApril 28, 2016

Overview

Registry

who.int

Start Date

April 28, 2016

End Date

February 28, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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

•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