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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04876131




Registration number
NCT04876131
Ethics application status
Date submitted
2/05/2021
Date registered
6/05/2021

Titles & IDs
Public title
Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
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
Secondary ID [1] 0 0
72065
Universal Trial Number (UTN)
Trial acronym
CHOICE UTI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complicated Urinary Tract Infection 0 0
Infection 0 0
Pediatric Infectious Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Risk difference between 1 dose and 3 doses IV in the proportion of participants with clinical failure at 72 hours
Timepoint [1] 0 0
72 hours
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
1 month
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
72 hours
Secondary outcome [4] 0 0
Risk difference between 1 dose and 3 doses IV in the proportion of participants with parental reported improvement
Timepoint [4] 0 0
72 hours
Secondary outcome [5] 0 0
Mean difference between 1 dose and 3 doses IV in duration of IV antibiotics usage
Timepoint [5] 0 0
7 days
Secondary outcome [6] 0 0
Mean difference between 1 dose and 3 doses IV in duration of oral antibiotic usage.
Timepoint [6] 0 0
14 days
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
14 days
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
1 month
Secondary outcome [9] 0 0
Risk difference in the proportion of participants with complications within 14 days of initial dose of IV antibiotics
Timepoint [9] 0 0
14 days
Secondary outcome [10] 0 0
Mean difference in the proportion of participants who experience at least one adverse event within 14 days of the initial dose of IV antibiotics
Timepoint [10] 0 0
14 days
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
14 days
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
24 hours
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Day 5 to 7
Secondary outcome [14] 0 0
Mean difference between 1 dose and 3 doses IV in the cost-effectiveness of treatment groups.
Timepoint [14] 0 0
Day 14
Secondary outcome [15] 0 0
Risk difference between the 1 dose and 3 doses IV groups in the proportion of patients with bacterial growth in urine culture (day 0)
Timepoint [15] 0 0
Day 0
Secondary outcome [16] 0 0
Risk difference between the 1 dose and 3 doses IV in the proportion of patients with bacterial growth in urine culture (Day 14)
Timepoint [16] 0 0
Day 14
Secondary outcome [17] 0 0
Risk difference between the 1 dose and 3 doses IV group in the proportion of patients administered antiemetics
Timepoint [17] 0 0
Up to day 3
Secondary outcome [18] 0 0
Risk difference between the 1 dose and 3 doses IV group in the proportion of patients administered antipyretic or analgesia.
Timepoint [18] 0 0
Up to day 3
Secondary outcome [19] 0 0
Risk difference between the 1 dose and 3 doses IV group in the proportion of patients with abnormal imaging.
Timepoint [19] 0 0
Up to1 month

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
Minimum age
3 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/05/2028
Actual
Sample size
Target
452
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Women and Children's Hospital - Adelaide
Recruitment hospital [2] 0 0
Monash Health - Melbourne
Recruitment hospital [3] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [4] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Melbourne
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland Province

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Children's Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Laila Ibrahim
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Laila Ibrahim
Address 0 0
Country 0 0
Phone 0 0
+61401765546
Fax 0 0
Email 0 0
laila.ibrahim@mcri.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified data set collected for this study will be available six months after publication of the results. The study protocol, analysis plan and consent forms will also be available. This will all be available by contacting Murdoch Children's Research Institute.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
6 months after publication of primary outcome
Available to whom?
Prior to this data being made available a data access agreement much be signed between the relevant parties and approval by the trial steering committee. Data will only be shared with recognised research institutions
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04876131