Trial events schedule
| Procedures | On-study period | Short term follow-up | Long term follow-up | |||||||||
| Screening/baseline (day 1) | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 30 | Day 60 | |
| Informed consent | X | |||||||||||
| Eligibility assessment | X | |||||||||||
| Demographics | X | |||||||||||
| Medical history | X | |||||||||||
| Gastroenteritis symptom history | X | |||||||||||
| Vaccination history (Australian Childhood Immunisation Register) | X | |||||||||||
| Results from routine laboratory tests | X | |||||||||||
| Stool sample | X | |||||||||||
| Results from urine sample (if done) | X | |||||||||||
| Randomisation | X | |||||||||||
| Trial drug administration (twice daily) | X | X | X | X | ||||||||
| Overnight nursing assessment of readiness for discharge (once daily)* | X | X | X | X | X | X | X | |||||
| Medical assessment by study doctor/nurse (twice daily)* | X | X | X | X | X | X | ||||||
| Carer diary card† | X | X | X | X | X | X | X | |||||
| Telephone contact† | X | X | X | X | X | X | X | X | X | |||
| Medically significant adverse event assessment | X | X | ||||||||||
| Concomitant medications | X | X | X | X | X | X | X | |||||
*During the period of hospitalisation.
†When participant is discharged.