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Table 5 Study assessments and specimen collection

From: Impact of systematic early tuberculosis detection using Xpert MTB/RIF Ultra in children with severe pneumonia in high tuberculosis burden countries (TB-Speed pneumonia): a stepped wedge cluster randomized trial

  Inclusion (Day 0) Day 3 Discharge 2 Weeks Post-Discharge (Extra visit)i Week 12
STANDARD OF CARE (control and intervention arm)
 WHO Standard of Carea,b X X X X (X) X
 TB clinical assessmentc   (X) (X) (X) (X) (X)
 TB treatment if neededb, d   (X) (X) (X) (X) (X)
TB-SPEED INTERVENTION (intervention arm only)
 Nasopharyngeal aspirate X      
 Stool sample X      
 Xpert MTB/RIF Ultra X      
 Immediate TB treatment initiation if positive Ultra testb X      
 Biobank: NPA and stool leftovers X      
 Tolerability and acceptability of NPA collectionh X      
ADDITIONAL STUDY ASSESSMENT AND PROCEDURES (control and intervention arm)
 Eligibility screening X      
 Clinical evaluatione X X X X (X) X
 Medical history X X X X (X) X
 Digital chest X-Ray X     (X) X
 Safety assessment X X X X (X) X
 TB drug adherence assessment   (X) (X) (X)   (X)
 TB treatment response     X   X
 HIV testf X      
 Malaria test X      
 Complete blood count X      
 Biobank: plasma, whole bloodg X      
  1. WHO World Health Organization, TB tuberculosis, NPA nasopharyngeal aspirate
  2. aSee Table 4
  3. bAccording to national treatment guidelines based on WHO recommendations
  4. cIn children with a clinical suspicion of TB (chronic symptoms, failure to respond to antibiotic treatment or TB exposure), TB will be evaluated using routine procedures. This can include Xpert MTB/RIF or Ultra (depending on local availability) on standard bacteriological samples as usually implemented at the ward
  5. dIn the intervention arm, TB treatment will be initiated immediately in case of a positive Ultra result. In both arms, TB treatment could be initiated in case of a strong clinical suspicion
  6. eContent of clinical evaluation varies with the visit; includes TB exposure and symptoms assessment at inclusion
  7. fPerformed if not available in the patient medical chart. In Côte d’Ivoire, should be discriminant for HIV 1 and 2
  8. gIn children < 18 months weighing < 5 kg, or presenting with signs of severe anaemia (conjunctival or palmar pallor): plasma sample for biobank will not be collected. Overall, volume of blood draw must not exceed 3 ml/kg/visit and 7 ml/kg/6 weeks
  9. hIn a subset of children only
  10. iAn extra TB visit will be performed if the child presents with signs and symptoms in favour of a presumptive TB