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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04876131
Registration number
NCT04876131
Ethics application status
Date submitted
2/05/2021
Date registered
6/05/2021
Date last updated
22/03/2024
Titles & IDs
Public title
Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
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Scientific title
CHOICE UTI - Clinical Efficacy of Single Dose (Daily) IV Antibiotics Followed by 2 Days Oral Antibiotics Compared to 3 Doses (Daily) IV Antibiotics for Children With Complicated Urinary Tract Infections: a Multicentre Randomised Trial
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Secondary ID [1]
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72065
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Universal Trial Number (UTN)
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Trial acronym
CHOICE UTI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Complicated Urinary Tract Infection
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Infection
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Pediatric Infectious Disease
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Benzylpenicillin - single dose
Treatment: Drugs - Benzylpenicillin - three days
Treatment: Drugs - Gentamicin - single dose
Treatment: Drugs - Gentamicin - three days
Treatment: Drugs - Cefalexin - post single dose of IV antibiotics for the remaining two days
Experimental: Arm 1, 1 dose - Single dose IV to cover Gram negative bacteria followed by 2 days of oral antibiotics
Single dose IV to cover Enterococcus spp
IV antibiotics are as per local institutional guidelines and microbiology eg: IV gentamicin with or without IV benzylpenicillin. Gentamicin is used when Gram Negative coverage is appropriate, benzylpenicillin is also used when Enterococcus coverage is appropriate, depending on local microbiology data. Once the IV component is complete the patient will be given an oral antibiotic (cefalexin) on day 2 and 3 of the study.
Active Comparator: Arm 2, 3 doses - 3 doses IV to cover Gram negative bacteria
3 days IV antibiotics to cover Enterococcus spp
IV antibiotics are as per local institutional guidelines and microbiology eg: IV gentamicin with or without IV benzylpenicillin. Gentamicin is used when Gram Negative coverage is appropriate, benzylpenicillin is also used when Enterococcus coverage is appropriate, depending on local microbiology data.
Treatment: Drugs: Benzylpenicillin - single dose
Participants will receive a single dose of IV antibiotic (benzylpenicillin).
Benzylpenicillin dosing: 1 month - 18 years, IV or Intramuscular (IM) 30 mg/kg (maximum 1.2 g) every 6 hours.
Treatment: Drugs: Benzylpenicillin - three days
Participants will receive three days of this IV antibiotic (benzylpenicillin).
Benzylpenicillin dosing: 1 month - 18 years, IV or Intramuscular (IM) 30 mg/kg (maximum 1.2 g) every 6 hours. For severe infections, use up to 60 mg/kg (maximum 2.4 g) every 4-6 hours.
Treatment: Drugs: Gentamicin - single dose
Participants will receive a single dose of IV antibiotic (gentamicin).
Gentamicin dosing: Children =10 years old: 7.5 mg/kg (maximum dose 320 mg) Children >10 years old: 6-7 mg/kg (maximum dose 560 mg)
Treatment: Drugs: Gentamicin - three days
Participants will receive three days of this IV antibiotic (gentamicin).
Gentamicin dosing: Children =10 years old: 7.5 mg/kg (maximum dose 320 mg) Children >10 years old: 6-7 mg/kg (maximum dose 560 mg)
Treatment: Drugs: Cefalexin - post single dose of IV antibiotics for the remaining two days
Oral antibiotic will be as per local guidelines. i.e. Cefalexin 25mg/kg (maximum dosage 500mg) 4 times a day or 33mg/kg (maximum dosage 500mg) 3 times a day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Risk difference between 1 dose and 3 doses IV in the proportion of participants with clinical failure at 72 hours
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Assessment method [1]
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Clinical failure is defined as persistence of baseline symptoms (fever, vomiting or rigors) or development of new symptoms (fever, vomiting or rigors) attributable to UTI at 72 hours. Assessment of clinical failure to be conducted at least 6 hours after antipyretic. Presence of fever, vomiting, or rigors reported by parents within 6 hours of assessment will be recorded as present at assessment.
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Timepoint [1]
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72 hours
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Secondary outcome [1]
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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.
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Assessment method [1]
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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
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Timepoint [1]
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14 days
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Secondary outcome [2]
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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
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Assessment method [2]
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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.
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Timepoint [2]
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1 month
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Secondary outcome [3]
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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.
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Assessment method [3]
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Proportions of participants transferred from HITH or ambulatory care to ward care within 72 hours of initial dose of IV antibiotics.
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Timepoint [3]
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72 hours
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Secondary outcome [4]
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Risk difference between 1 dose and 3 doses IV in the proportion of participants with parental reported improvement
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Assessment method [4]
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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.
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Timepoint [4]
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72 hours
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Secondary outcome [5]
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Mean difference between 1 dose and 3 doses IV in duration of IV antibiotics usage
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Assessment method [5]
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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
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Timepoint [5]
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7 days
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Secondary outcome [6]
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Mean difference between 1 dose and 3 doses IV in duration of oral antibiotic usage.
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Assessment method [6]
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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.
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Timepoint [6]
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14 days
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Secondary outcome [7]
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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
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Assessment method [7]
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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.
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Timepoint [7]
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14 days
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Secondary outcome [8]
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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
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Assessment method [8]
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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.
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Timepoint [8]
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1 month
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Secondary outcome [9]
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Risk difference in the proportion of participants with complications within 14 days of initial dose of IV antibiotics
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Assessment method [9]
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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.
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Timepoint [9]
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14 days
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Secondary outcome [10]
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Mean difference in the proportion of participants who experience at least one adverse event within 14 days of the initial dose of IV antibiotics
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Assessment method [10]
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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.
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Timepoint [10]
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14 days
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Secondary outcome [11]
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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
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Assessment method [11]
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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.
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Timepoint [11]
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14 days
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Secondary outcome [12]
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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.
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Assessment method [12]
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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
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Timepoint [12]
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24 hours
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Secondary outcome [13]
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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
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Assessment method [13]
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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
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Timepoint [13]
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Day 5 to 7
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Secondary outcome [14]
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Mean difference between 1 dose and 3 doses IV in the cost-effectiveness of treatment groups.
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Assessment method [14]
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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.
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Timepoint [14]
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Day 14
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Secondary outcome [15]
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Risk difference between the 1 dose and 3 doses IV groups in the proportion of patients with bacterial growth in urine culture (day 0)
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Assessment method [15]
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Risk difference between the 1 dose and 3 doses IV groups in the proportion of patients with bacterial growth: for example E.Coli, Enterococcus.
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Timepoint [15]
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Day 0
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Secondary outcome [16]
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Risk difference between the 1 dose and 3 doses IV in the proportion of patients with bacterial growth in urine culture (Day 14)
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Assessment method [16]
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Risk difference between the 1 dose and 3 doses IV groups in the proportion of patients with bacterial growth: for example E.Coli, Enterococcus.
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Timepoint [16]
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Day 14
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Secondary outcome [17]
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Risk difference between the 1 dose and 3 doses IV group in the proportion of patients administered antiemetics
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Assessment method [17]
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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.
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Timepoint [17]
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Up to day 3
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Secondary outcome [18]
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Risk difference between the 1 dose and 3 doses IV group in the proportion of patients administered antipyretic or analgesia.
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Assessment method [18]
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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.
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Timepoint [18]
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Up to day 3
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Secondary outcome [19]
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Risk difference between the 1 dose and 3 doses IV group in the proportion of patients with abnormal imaging.
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Assessment method [19]
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Risk difference between the 1 dose and 3 doses IV group in the proportion of patients with Ultrasound reported abnormalities of the renal tract.
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Timepoint [19]
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Up to1 month
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Eligibility
Key inclusion criteria
3 months (corrected age) to 18 years
- 2 or more of the following present: Fever (must be present), Vomiting, Rigors, History
of recurrent UTI, Urological abnormalities, Tachycardia
- Urine sample available (Urine culture must have been collected prior to antibiotic
treatment, either at the GP or ED - in order to assess urine culture as per below).
- Abnormal urinary dipstick leucocyte esterase >1+ or nitrite positive OR =5 White Blood
Cells (WBCs) per high-power field in centrifuged urine OR= 10 White Blood Cells (WBCs)
per mm3 in uncentrifuged urine and bacteriuria with any bacteria per high-power field
- ED clinician determines the child requires treatment with IV antibiotics
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Minimum age
3
Months
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Maximum age
18
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Sepsis (requiring inotropic support or more than 20ml/kg of fluid bolus in Emergency
Department)
- Known allergy to all once daily study drug options (gentamicin or ceftriaxone or
amikacin)
- If the patient has another co-existing condition which requires (based on established
evidence-based guidelines) more than 1 dose of IV antibiotics eg meningitis
- Known impaired renal function (renal transplant patients or a 10% increase in measured
expected creatinine for age/height at ED presentation )
- Unrepaired posterior urethral valves
- Indwelling stent and fever
- Previously enrolled participants in the CHOICE UTI trial.
- No available oral antibiotic option for this UTI: urine culture result already
available and multi-resistant organism with susceptibility only to IV antibiotics;
previous UTI with multi-resistant organism not an exclusion
- Previous IV antibiotics for same UTI episode eg interhospital transfer whereby
significant time has passed since first dose IV
- Patients with clinically suspected renal abscess e.g., extreme renal tenderness, out
of keeping with pyelonephritis (clinically determined).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
16/05/2028
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Actual
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Sample size
Target
452
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Women and Children's Hospital - Adelaide
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Recruitment hospital [2]
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Monash Health - Melbourne
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Recruitment hospital [3]
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Royal Children's Hospital - Parkville
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Recruitment hospital [4]
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Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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3168 - Melbourne
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment postcode(s) [4]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland Province
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Royal Children's Hospital
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Urinary tract infections (UTI) are commonly encountered in children, with 7% diagnosed with
at least one UTI by the age of 19 years. The evidence for treatment of uncomplicated UTI is
clear; oral antibiotics are as good as intravenous (IV) antibiotics, usually for a total of 7
days. Complicated UTIs (cUTIs) on the other hand, are common reasons for hospital admissions
for IV antibiotics and constitute a major burden for healthcare systems. There is
considerable variation in care for children who present with UTI and have complicating
features such as vomiting, dehydration, urological abnormalities or have a previous history
of UTI. Australian and international guidelines lack clear, evidence-based recommendations to
guide treatment in this group. Without gold standard evidence, these children will continue
to receive unnecessary IV antibiotics, longer hospital stays and poorer health outcomes.
This multicentre, non-inferiority randomised trial will investigate if One dose - single dose
of IV followed by 2 days oral antibiotics is as non-inferior to Three doses for children with
UTI and co-existing complicating factors presenting to the Emergency Department (ED). In
other words, this study will compare if a single dose of IV antibiotics plus two days oral
antibiotics is as clinically effective as 3 doses antibiotics in resolving UTI symptoms at 72
hours after the first dose of IV antibiotics, for complicated UTIs in children presenting to
the ED. All participants will receive a total of 7 days of antibiotics for the complicated
urinary tract infection. If 1 dose IV and 2 days oral antibiotics is found to be as good as 3
days, the duration of IV antibiotics for complicated UTI can be reduced along with avoidance
of the inherent risks of unnecessary hospital admission by administering a single IV dose in
an outpatient/ED setting. On the other hand if a single IV dose results in prolonged symptoms
or treatment failure, this will inform practice for the proportion of children who have a
single dose of IV antibiotics in the ED and are sent home on oral antibiotics. Regardless of
the outcome, this trial will inform clinical practice for complicated UTI to improve health
outcomes for this group.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04876131
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Laila Ibrahim
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Address
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Murdoch Children's Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Laila Ibrahim
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Address
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Country
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Phone
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+61401765546
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04876131
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