Table 1

Trial events schedule

ProceduresOn-study periodShort term follow-upLong term follow-up
Screening/baseline (day 1)Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day 10Day 30Day 60
Informed consentX
Eligibility assessmentX
Medical historyX
Gastroenteritis symptom historyX
Vaccination history (Australian Childhood Immunisation Register)X
Results from routine laboratory testsX
Stool sampleX
Results from urine sample (if done)X
Trial drug administration (twice daily)XXXX
Overnight nursing assessment of readiness for discharge (once daily)*XXXXXXX
Medical assessment by study doctor/nurse (twice daily)*XXXXXX
Carer diary card†XXXXXXX
Telephone contact†XXXXXXXXX
Medically significant adverse event assessmentXX
Concomitant medicationsXXXXXXX
  • *During the period of hospitalisation.

  • †When participant is discharged.