Tuberculosis child multidrug-resistant preventive therapy: TB CHAMP trial

• Register: ISRCTN
• Last refreshed on: 22 January 2024
• Main ID: ISRCTN92634082
• Date of registration: 28/04/2016
• Prospective Registration: Yes
• Primary sponsor: Stellenbosch University
• Public title: Tuberculosis child multidrug-resistant preventive therapy: TB CHAMP trial
• Scientific title: A phase III cluster randomised placebo-controlled trial to assess the efficacy of preventive therapy in child contacts of multidrug-resistant (MDR) tuberculosis (TB)
• Date of first enrolment: 01/10/2016
• Target sample size: 1556
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN92634082
• Study type: Interventional
• Study design: Parallel group 2 arm,cluster randomised double blind placebo-controlled trial (Prevention)
• Phase: Phase III

Countries of recruitment

South Africa

Contacts

• Name: Ellen Owen-Powell

• Name: Margaret Thomason

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Multi drug resistant tuberculosis (MDR-TB)
Infections and Infestations

Intervention(s)

TB-CHAMP will compare 24 weeks of daily levofloxacin against 24 weeks of daily placebo. All eligible children within the household will be treated with the same drug (either all levofloxacin or all placebo). Households will be randomised (allocated by chance) to be in either the levofloxacin or placebo group. This allocation is carried out by a computer, and the households have an equal chance of being in either group.

This is a “double blind” study, which means that neither the children (or their family) or the researchers will know whether the tablets each child is taking are levofloxacin or placebo.

Children who participate in the study will undergo approximately ten study visits over two years. Enough tablets will be prescribed for the child to take daily until they are seen at their next clinic visit. Visits will be monthly whilst taking the study drugs, and then every three months. At each visit details of the child’s health, height and weight will be recorded, as well as information about how well they take their medicines and if there are any particular problems taking them. The study tests to be done on the children (investigation for TB, blood tests, etc.) are part of routine recommended clinical care in children exposed to MDR-TB. At some visits some additional blood and urine samples will be collected for storage and future testing.

Primary Outcome(s)

Incident TB disease (probable or confirmed) including TB death, by 48 weeks post-randomisation

Secondary Outcome(s)

1. Mortality (all cause, non-traumatic, and TB related)
2. Adverse events = grade 3 (at least possibly associated) during 24 weeks of treatment
3. Percentage of levofloxacin or levofloxacin-placebo doses ingested and retained over 24 weeks
4. TB disease over 96 weeks
5. Incidence of levofloxacin resistant TB disease

Secondary ID(s)

MR/M007340/1

Source(s) of Monetary Support

Joint Global Health Trials Scheme of the Department for International Development (UK), Wellcome Trust, Medical Research Council, South African Medical Research Council

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 1. Stellenbosch University HREC, 13/05/2016, ref: M16/02/009 2. Medicines Control Council of South Africa (MCC), 08/12/2016, ref: 20160128

Results

• Results available: Yes
• Date Completed: 28/02/2023