Multi drug resistant tuberculosis (MDR-TB) Infections and Infestations
Conditions
Interventions
TB-CHAMP will compare 24 weeks of daily levofloxacin (15-20 mg/kg, maximum 750 mg) against 24 weeks of daily placebo. All eligible children within the household will be treated with the same drug (eit
Sponsors
Stellenbosch University
Eligibility
Sex/Gender
All
Age
0 Years to 18 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incident TB disease (probable or confirmed) including TB death, by 48 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
South Africa
Contacts
Public ContactEllen;Margaret Owen-Powell;Thomason
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Outcome results
None listed