Risk difference between 1 dose and 3 doses IV in the proportion of participants readmitted or attending the ED within 14 days of the initial dose of IV antibiotic.
Proportion of readmissions within 14 days of the initial dose of IV antibiotics due to persistent fever, vomiting, rigors, or clinical deterioration (eg poor feeding, dehydration) that can be attributable to the UTI
Risk difference between 1 dose and 3 doses IV in the proportion of participants readmitted or attending the ED within 1 month of the initial dose of IV antibiotics
Proportion of readmission within 1 month of the initial dose of IV antibiotics due to persistent fever, vomiting, rigors, or clinical deterioration (eg poor feeding, dehydration) that can be attributable to the UTI.
Risk difference between 1 dose and 3 doses IV in proportion of participants transferred from HITH or ambulatory care to ward care within 72 hours of initial dose of IV antibiotics.
Proportions of participants transferred from HITH or ambulatory care to ward care within 72 hours of initial dose of IV antibiotics.
Risk difference between 1 dose and 3 doses IV in the proportion of participants with parental reported improvement
Proportion of patients who are reported as 'generally improved/better' at 72 hours of the initial IV antibiotic dose. This will be reported via the daily diary completed by the parent on day 1, 2 and 3.
Mean difference between 1 dose and 3 doses IV in duration of IV antibiotics usage
Mean difference between 1 dose and 3 doses IV group in duration (number of days up to 1 decimal point) of IV antibiotics, i.e. mean time difference from first dose of IV antibiotics to last dose of IV antibiotics
Mean difference between 1 dose and 3 doses IV in duration of oral antibiotic usage.
Mean difference between 1 dose and 3 doses IV in the duration (number of days up to 1 decimal point) of oral antibiotics administered to patients, i.e mean time difference between last dose of IV antibiotics and the last dose of oral antibiotics.
Risk difference between 1 dose and 3 doses IV in the proportion of participants with recurrence of UTI symptoms within 14 days of initial dose of IV antibiotics
Risk difference between 1 dose and 3 doses IV in the proportion of participants with recurrence of UTI symptoms within 14 days of the first dose of IV antibiotics. Recurrence of symptoms depends on what symptoms the patient initially presented with but may be classified as recurrence of fever, vomiting, rigors or tachycardia.
Risk difference between 1 dose and 3 doses IV in the proportion of participants with recurrence of UTI symptoms within 1 month of initial dose of IV antibiotics
Risk difference between 1 dose and 3 doses IV in the proportion of participants with recurrence of UTI symptoms within 1 month of initial dose of IV antibiotics. Recurrence of symptoms depends on what symptoms the patient initially presented with but may be classified as recurrence of fever, vomiting, rigors or tachycardia.
Risk difference in the proportion of participants with complications within 14 days of initial dose of IV antibiotics
Risk difference in the proportion of participants with complications within 14 days of initial dose of IV antibiotics. Complications are defined as abscess, sepsis, meningitis from the initial IV antibiotics dose to 14 days after the initial dose that are attributable to the UTI as judged by a clinician.
Mean difference in the proportion of participants who experience at least one adverse event within 14 days of the initial dose of IV antibiotics
Mean difference in the proportion of participants who experience at least one adverse event within 14 days of the initial dose of IV antibiotics. An adverse event is described as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Risk difference between the 1 dose and 3 doses IV groups in the proportion of participants who experience an allergic reaction attributable to the antibiotics administered within 14 days of the initial dose of IV antibiotics
Risk difference in the proportion of participants who experience an allergic reaction attributable to the antibiotics administered within 14 days of the initial dose of IV antibiotics. An allergic reaction is classified as an overreactive immune system to a harmless substance known as an allergen in this case a medicinal (investigational) product.
Mean difference between 1 dose and 3 doses IV on the weighted total score of the Child Health Utility instrument administered within 24 hours after initial dose of IV antibiotics.
The Child Health Utility instrument is a 9 item parent-rated, preference-weighted measure used to calculate quality adjusted life years for children. This survey consist of 9 questions asking how the child is feeling and questions about their activity levels. The minimum score is zero and the maximum score for this survey is 1 which indicates optimal health. This should be completed within 24 hours of initial IV antibiotics
Mean difference between 1 dose and 3 doses IV on the weighted total score of the Child Health Utility instrument administered between day 5-7 of initial dose of IV antibiotics
The Child Health Utility instrument is a 9 item parent-rated, preference-weighted measure used to calculate quality adjusted life years for children. This survey consist of 9 questions asking how the child is feeling and questions about their activity levels. The minimum score is zero and the maximum score for this survey is 1 which indicates optimal health. This should be completed between day 5 to 7 after initial IV antibiotics
Mean difference between 1 dose and 3 doses IV in the cost-effectiveness of treatment groups.
Mean difference between 1 dose and 3 doses IV in the cost-effectiveness of treatment. As judged by survey provided to the families asking about their out of pocket expenses or loss of productive work hours.
Risk difference between the 1 dose and 3 doses IV groups in the proportion of patients with bacterial growth in urine culture (day 0)
Risk difference between the 1 dose and 3 doses IV groups in the proportion of patients with bacterial growth: for example E.Coli, Enterococcus.
Risk difference between the 1 dose and 3 doses IV in the proportion of patients with bacterial growth in urine culture (Day 14)
Risk difference between the 1 dose and 3 doses IV groups in the proportion of patients with bacterial growth: for example E.Coli, Enterococcus.
Risk difference between the 1 dose and 3 doses IV group in the proportion of patients administered antiemetics
Risk difference between the 1 dose and 3 doses IV in the proportion of patients administered antiemetics (commonly used antiemetics in children are metoclopramide, domperidone, ondansetron and prochlorperazine). As determined by parent reported diary, completed daily for the first 3 days after enrolment.
Risk difference between the 1 dose and 3 doses IV group in the proportion of patients administered antipyretic or analgesia.
Risk difference between the 1 dose and 3 doses IV group in the proportion of patients administered antipyretic or analgesia (commonly used antipyretics and analgesia in children are paracetamol, ibuprofen, naproxen). As determined by parent reported diary, completed daily for the first 3 days after enrolment.
Risk difference between the 1 dose and 3 doses IV group in the proportion of patients with abnormal imaging.
Risk difference between the 1 dose and 3 doses IV group in the proportion of patients with Ultrasound reported abnormalities of the renal tract.