Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) : Amoxicillin Duration

INTERVENTION: Name: Amoxicillin (250mg/5mL) Dose: 25mg/kg per dose, 3 times per day for participants up to 40kg Duration: 2‐5 days of therapy (Arms 1‐4) Arm 1 ‐ 2 days of therapy Arm 2 ‐ 3 days of therapy Arm 3 ‐ 4 days of therapy Arm 4 ‐ 5 days of therapy (standard of care) Mode: Oral syrup Name: Amoxicillin 500mg capsule Dose: 25mg/kg per dose, 3 times per day for participants over 40kg Duration: 2‐5 days of therapy (Arms 1‐4) Arm 1 ‐ 2 days of therapy Arm 2 ‐ 3 days of therapy Arm 3 ‐ 4 days of therapy Arm 4 ‐ 5 days of therapy (standard of care) Mode: Oral capsules Intervention adherence to the randomised dose will be self‐reported in follow‐up electronic surveys. CONDITION: Acute Respiratory Infection;Community Acquired Pneumonia; ; Acute Respiratory Infection ; Community Acquired Pneumonia Infection ‐ Other infectious diseases Respiratory ‐ Other respiratory disorders / diseases PRIMARY OUTCOME: The primary outcome is the proportion of children with symptom resolution (returning to pre‐morbid health state, as assessed by parents/carers) assessed at 7 days following presentation. The outcome is assessed by parent report using a study specific electronic questionnaire on day 7 post‐intervention commencement.[Day 7 post‐intervention commencement.] SECONDARY OUTCOME: Proportion of children unable to comply with treatment allocation (measured as the proportion of total children in each treatment group whose treatment regime is modified by day 7). ; This outcome will be assessed by parent reported study specific electronic questionnaire on day 7 post intervention commencement. The medical record will be checked for any participant who reports non‐adherence to the treatment allocation on day 7.[Day 7 post‐intervention commencement.] Proportion of children who are free from cough by day 7, 14, 21 and 28 (d7; d14; d21; d28) for children in each treatment group as assessed by parents in electronic questionnaires on day 7, 14, 21 and 28. The Canadian Acute Respiratory Illness and Flu Scale will be used to assess symptoms.[Day 7, 14, 21 and 28 post‐intervention commencement.] Proportion of children who are free from fever by day 7, 14, 21 and 28 (d7; d14; d21; d28) for children in each treatment group. ; This outcome will be assessed by parent report in electronic questionnaires. Parents will be asked if the temperature was measured with a thermometer and to record the measured temperature.[Day 7, 14, 21 and 28 post‐intervention commencement.] Proportion of children who have returned to their pre‐morbid health state by day, 14, 21 and 28 (d14; d21; d28) for children in each treatment group as reported by parents a study specific electronic questionnaires.[Day 7, 14, 21 and 28 post‐intervention commencement.] Time to full recovery of ARI symptoms (measured in days, followed until day 28) for children in each treatment group. ; The outcome is assessed using parent reported outcomes from electronic questionnaires on day 7, 14, 21 and 28 post‐intervention commencement. The Canadian Acute Respiratory Illness and Flu Scale is used to assess symptom recovery.[Number of Days (until day 28). ; The outcome is assessed in a parent reported electronic questionnaire each week (on day 7, 14, 21 and 28 post intervention commencement until the participant is recovered)] Time to return to normal childhood activities defined as: sufficient improvement to return to day‐care; school; playgroups or other social outings (measured in days, followed until day 28) for children in each treatment group. ; This outcome will be assessed with parent report a study specific electronic questionnaire completed on day 7, 14, 21 and 28 post‐intervention commencement.[Number of days (until day 28). ; This outcome will be assessed via parent report captured in a study specific electronic questionnaire on day 7, 14, 21, 28 post intervention commencement. ; Assessed on day 7, 14, 21 and 28 post‐intervention commencement.] Time to seek further healthcare e.g. emergency department or general practice visit (measured in days, followed until day 28) for children in each treatment group. ; The medical record will also be checked for any participant who does not complete the electronic surveys or any participant who indicates they sought further healthcare since the last survey.[Number of days (until day 28). ; This outcome will be assessed via parent report captured in in the electronic questionnaires on day 7, 14, 21, 28 post intervention commencement. ] INCLUSION CRITERIA: 1) Participants must be aged between greater than or equal to 6 months and 15 years. 2) Presence of fever and cough in the past 96 hours. 3) Total duration of symptoms <7 days at the time of enrolment. 4) Physician‐diagnosed pneumonia; OR acute lower respiratory infection where antibiotics would be considered