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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 6 February 2017
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:  http://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: Margaret    Thomason
Address:  MRC Clinical Trials Unit at UCL Institute of Clinical Trials & Methodology Aviation House 125 Kingsway WC2B 6NH London United Kingdom
Telephone:
Email:
Affiliation: 
Name: Ellen    Owen-Powell
Address:  MRC Clinical Trials Unit at UCL Institute of Clinical Trials & Methodology Aviation House 125 Kingsway WC2B 6NH London United Kingdom
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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