Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

Summary

Participation Requirements

Description

Study design: An open label, multi-centre, pragmatic, non-inferiority randomised controlled trial (RCT). It will incorporate a two-arm, non-inferiority design with parallel groups and 1:1 allocation of children with ?3 complicated features of UTI presenting to the ED in whom clinicians deem parenter...

Study design: An open label, multi-centre, pragmatic, non-inferiority randomised controlled trial (RCT). It will incorporate a two-arm, non-inferiority design with parallel groups and 1:1 allocation of children with ?3 complicated features of UTI presenting to the ED in whom clinicians deem parenteral antibiotics are required. Primary objective: The primary objective of this trial is to compare whether Early switch - single dose of IV plus 2 days oral antibiotics is as clinically effective (non-inferior) in resolving UTI symptoms at 72 hours after the first IV dose, as 3 days IV for complicated urinary tract infections presenting to the ED. Definition: Early switch: Single dose IV to cover Gram negative bacteria followed by 2 days oral antibiotics with or without Single dose IV to cover Enterococcus spp followed by 2 days oral antibiotics 3-days IV: 3 days IV to cover Gram negative bacteria with or without 3 days IV antibiotics to cover Enterococcus spp Actual antibiotics used will be based on individual sites, local microbiology and antibiotic susceptibility data and clinical context. Empiric antibiotics used will cover Gram negative organisms with or without Enterococcus cover. Secondary objective: The secondary objectives of this trial are to compare the following between the Early switch and the 3-days IV arms: Readmission rates due to persistent fever, vomiting, rigors, or clinical deterioration (eg poor feeding, dehydration) within 14 days of the initial dose of IV antibiotics Readmission rates due to persistent fever, vomiting, rigors, or clinical deterioration (eg poor feeding, dehydration) within 1 month of the initial dose of IV antibiotics Transfer rate from Hospital in the Home (HITH)/ambulatory care to ward care during admission within 72 hours of the initial dose of IV antibiotics Time to resolution of fever, vomiting, rigors within 72 hours of the initial dose of IV antibiotics as reported by parents/guardian Improvement as determined by parents/guardian at 72 hours after the first IV dose Antiemetic use for 72 hours from the initial IV antibiotic dose Duration of IV antibiotics (actually received by patient) from the first dose of IV antibiotics to last dose of IV antibiotics Duration of oral antibiotics (actually received by patient) from the first dose of oral antibiotics (after IV antibiotics started) to last dose of IV antibiotics Total duration of antibiotics: sum of duration of IV antibiotics and oral antibiotics Recurrence of UTI within 14 days from the first dose of IV antibiotics Recurrence of UTI within 1 month from the first dose of IV antibiotics Complications of UTI from the initial IV antibiotics dose to 14 days after the initial dose. Adverse events from the initial IV antibiotics dose to 14 days after the initial dose. Quality of life (QoL) indicators on Day 1 of IV antibiotics (within 24 hours of initial IV antibiotics) and after Day 4 (72 hours up to Day 7) Cost-effectiveness Follow up microbiological urine culture after commencing IV antibiotics Intervention: Patients who are eligible for the study will be randomised to receive 1 dose of IV antibiotics (and 2 days oral antibiotics) or 3 days of IV antibiotics. All participants will receive a total of 7 days treatment with antibiotics for the complicated urinary tract infection. Study methodology: Enrolment and randomisation: During ED assessment, clinicians will identify patients with a suspected UTI and screen patients against eligibility criteria. The relevant clinical team at each site will receive standardised, study specific education based on centrally developed study education materials. Presence of the following symptoms/sign will be recorded at baseline (fever, vomiting, rigors, tachycardia). Participants will be randomised to one of the 2 arms after written informed consent is obtained. Intervention Day 1: The first dose of the antibiotics will be commenced in the ED. Care of the patient will be as per routine clinical care. Decision for admission to hospital and location of treatment (ambulatory/Hospital-in-the-Home care) will be determined by the treating clinician as per routine clinical care. Parents will be provided with a thermometer and a diary to record a daily assessment of their child (fever, rigors, vomiting). Intervention Day 4: 72 hours after the first dose of IV antibiotics, a research nurse will conduct an assessment over phone or telehealth to obtain the primary outcome data: Persistence of baseline symptoms (fever, vomiting, rigors) or development of these symptoms (if not previously present) since baseline will be documented. Any ambiguity with regards to symptoms being attributable to UTI will be judged by a blinded clinician external to the research team. Follow up Day 14: 14 days after the first dose of IV antibiotics, a research nurse will conduct an assessment over phone or telehealth for follow up data including whether General Practitioner (GP) or ED visit or readmission occurred for UTI and total duration of antibiotics taken by the patient. Follow up 1 month: 1 month after the first dose of IV antibiotics, a research nurse will conduct an assessment over phone or telehealth for follow up data including whether GP or ED visit or readmission occurred for UTI, total duration of antibiotics taken by the patient.

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