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Table 2 Inclusions and exclusion criteria for adult index cases and child trial participants

From: Levofloxacin versus placebo for the prevention of tuberculosis disease in child contacts of multidrug-resistant tuberculosis: study protocol for a phase III cluster randomised controlled trial (TB-CHAMP)

Adult index case inclusion criteria Child participant inclusion criteria Child participant exclusion criteria
1. Age ≥ 18 years
2. Bacteriologically confirmed pulmonary TB diagnosed from a sputum sample within the preceding 6 months
3. Genotypic and/or phenotypic resistance to isoniazid and rifampicina
4. Written informed consent to provide routine TB episode data
5. At least 1 child household contact aged < 5 years reported to have been residing in the same household as the adult index case in the previous 6 months
1. Child aged < 5 years who is a household contact of an enrolled adult MDR-TB index case diagnosed during the previous 6 monthsb
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 testingc
4. Consent obtained from the parent or legal guardian for the child to be enrolled in the study
1. TB disease at enrolment
2. Currently on isoniazid or a fluoroquinoloned for ≥ 14 days
3. Treated for TB in the previous 12 months
4. Known concurrent exposure to an isoniazid-susceptible (including rifampicin-monoresistant) index casee
5. Children with myasthenia gravis or Guillain–Barré syndrome
  1. aIf only tested by Xpert MTB/RIF or other approved molecular tests, the index case can be included if rifampicin-resistant, without other confirmed DST. Rates of rifampicin-resistant, isoniazid-susceptible TB are very low in this context [58]. Samples found to be rifampicin-resistant will subsequently be confirmed by other molecular testing and/or by phenotypic DST
  2. bChildren aged < 5 years who are identified as having been living in the same household as an enrolled adult MDR-TB index case at any point during the preceding 6 months are eligible, if the exposure has lasted > 2 weeks
  3. cHIV-infected and uninfected children will be included
  4. dLevofloxacin, moxifloxacin, ofloxacin or ciprofloxacin
  5. eAny child found to have been in contact with an index case who has isoniazid- or rifampicin-susceptible TB will be referred to the local clinic to access preventive therapy, as per WHO guidelines