Back to resultsIndividualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infection
Primary Purpose
Febrile Urinary Tract Infection
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Individualized antibiotic therapy
Standard antibiotic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Febrile Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria:
- Clinical suspicion of febrile (≥38 °C) urinary tract infection.
Positive urine culture of uropathogenic bacteria obtained by either suprapubic bladder aspiration, sterile intermittent catheterization, or midstream urine.
- Suprapubic bladder aspiration: any growth of bacteria.
- Sterile intermittent catheterization: monoculture with ≥10^3 cfu/ml.
- Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10^4 cfu/ml.
- Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10^5 cfu/ml in one test and 10^3 cfu/ml in another test.
- Midstream urine x 1 (≥10 years of age): Monoculture with ≥10^5 cfu/ml.
- 3 months to 13 years of age (corrected age in case of premature birth).
- Parents fluent in Danish or English.
- Informed consent both parents.
All children who do not receive any empirical antibiotic therapy but have a positive urine culture (approximately 48 hours after urine sample collection) can be included if fever (≥ 38.0 °C) is present and the child is initiated with relevant antibiotic therapy. ¨
Children can be included regardless of whether intravenous or oral antibiotics were given as empirical therapy.
Exclusion Criteria:
- Non-Danish civil registration number.
- Not resident in the Capital Region or Region Zealand in Denmark at primary visit.
- Previous inclusion in the trial.
- History of febrile (≥38 °C) urinary tract infection in the last 28 days before the primary visit.
- Antibiotic treatment in the last two weeks before the primary visit.
- Three or more episodes with febrile (≥38 °C) urinary tract infection within one year of the primary visit (including the current episode).
- Previous complicated episode of febrile (≥38 °C) urinary tract infection (e.g., renal abscess or urosepticemia)
- Non-compliance ≥3 doses of antibiotics during empirical therapy.
- Elevated creatinine.
- Prophylactic antibiotic treatment.
- Known urogenital abnormalities (i.e., obstructing uropathies; vesicoureteral reflux; multicystic dysplasia; renal dysplasia; renal hypoplasia; renal agenesis; duplex kidney; polycystic kidney disease; neurogenic bladder dysfunction; hypospadias).
- Septic.
- Positive blood culture (if contamination is not suspected).
- Immune deficiency.
- Systemic immunosuppressive therapy.
Sites / Locations
- Copenhagen University Hospital RigshospitaletRecruiting
- Copenhagen University Hospital HerlevRecruiting
- Copenhagen University Hospital HillerødRecruiting
- Copenhagen University Hospital HolbækRecruiting
- Copenhagen University Hospital HvidovreRecruiting
- Copenhagen University Hospital Nykøbing FalsterRecruiting
- Copenhagen University Hospital RoskildeRecruiting
- Copenhagen University Hospital SlagelseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Individual group
Standard group
Arm Description
In the individual group, the participants receive individualized antibiotic therapy.
In the standard group, the participants receive standard antibiotic therapy as defined by the national guideline.
Outcomes
Primary Outcome Measures
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Number of days with antibiotic therapy
Secondary Outcome Measures
Number of days with absence from school or daycare due to illness
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Full Information
NCT ID
NCT05301023
First Posted
March 11, 2022
Last Updated
March 12, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05301023
Brief Title
Individualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infection
Official Title
Individualized Antibiotic Therapy Versus Standard Care in Children With Febrile Urinary Tract Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Hvidovre University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An investigator-initiated, open-label, multi-center, randomized, non-inferiority trial of children aged 3 months to 13 years with acute uncomplicated febrile urinary tract infection. The primary objective is to determine whether individualized antibiotic therapy based on an algorithm (experimental arm) versus standard antibiotic therapy of 10 days (control arm) can reduce the number of days with antibiotic therapy within 28 days after treatment initiation without increasing the risk of recurrent urinary tract infection regardless of the pathogen or death of any cause within 28 days after end of treatment. Children will be randomized 1:1. The medical treatments received are identical in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Urinary Tract Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
408 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individual group
Arm Type
Experimental
Arm Description
In the individual group, the participants receive individualized antibiotic therapy.
Arm Title
Standard group
Arm Type
Active Comparator
Arm Description
In the standard group, the participants receive standard antibiotic therapy as defined by the national guideline.
Intervention Type
Other
Intervention Name(s)
Individualized antibiotic therapy
Intervention Description
Individualized antibiotic therapy is based on the duration of illness after treatment initiation, as the antibiotic therapy can be stopped three days after the participant has become healthy. The participant is classified as healthy if he/she is afebrile (<38.0 °C), has experienced significant clinical improvement, and have no flank pains or dysuria.
Intervention Type
Other
Intervention Name(s)
Standard antibiotic therapy
Intervention Description
Standard antibiotic therapy is 10 days of antibiotic therapy regardless of the duration of illness after treatment initiation.
Primary Outcome Measure Information:
Title
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Time Frame
within 28 days after end of treatment
Title
Number of days with antibiotic therapy
Time Frame
within 28 days after treatment initiation
Secondary Outcome Measure Information:
Title
Number of days with absence from school or daycare due to illness
Time Frame
within 28 days after randomization
Title
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Time Frame
within 100 days after end of treatment
Other Pre-specified Outcome Measures:
Title
Number of hospital days related to urinary tract infection symptoms
Time Frame
within 28 days after end of treatment
Title
Number of days with a physical or virtual (phone or online) consultation
Time Frame
From date of randomization until the date of treatment stop for the baseline infection, assessed up to 14 days
Title
Proportion of participants with recurrent infection with a bacterium resistant to the antibiotic given for the primary infection
Time Frame
within 100 days after end of treatment
Title
Proportion of participants with a serious adverse event
Description
Defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, or jeopardizes the patient
Time Frame
within 100 days after randomization
Title
Proportion of participants with an antibiotic-related non-serious adverse event
Time Frame
within 28 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical suspicion of febrile (≥38 °C) urinary tract infection.
Positive urine culture of uropathogenic bacteria obtained by either suprapubic bladder aspiration, sterile intermittent catheterization, or midstream urine.
Suprapubic bladder aspiration: any growth of bacteria.
Sterile intermittent catheterization: monoculture with ≥10^3 cfu/ml.
Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10^4 cfu/ml.
Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10^5 cfu/ml in one test and 10^3 cfu/ml in another test.
Midstream urine x 1 (≥10 years of age): Monoculture with ≥10^5 cfu/ml.
3 months to 13 years of age (corrected age in case of premature birth).
Parents fluent in Danish or English.
Informed consent both parents.
All children who do not receive any empirical antibiotic therapy but have a positive urine culture (approximately 48 hours after urine sample collection) can be included if fever (≥ 38.0 °C) is present and the child is initiated with relevant antibiotic therapy. ¨
Children can be included regardless of whether intravenous or oral antibiotics were given as empirical therapy.
Exclusion Criteria:
Non-Danish civil registration number.
Not resident in the Capital Region or Region Zealand in Denmark at primary visit.
Previous inclusion in the trial.
History of febrile (≥38 °C) urinary tract infection in the last 28 days before the primary visit.
Antibiotic treatment in the last two weeks before the primary visit.
Three or more episodes with febrile (≥38 °C) urinary tract infection within one year of the primary visit (including the current episode).
Previous complicated episode of febrile (≥38 °C) urinary tract infection (e.g., renal abscess or urosepticemia)
Non-compliance ≥3 doses of antibiotics during empirical therapy.
Elevated creatinine.
Prophylactic antibiotic treatment.
Known urogenital abnormalities (i.e., obstructing uropathies; vesicoureteral reflux; multicystic dysplasia; renal dysplasia; renal hypoplasia; renal agenesis; duplex kidney; polycystic kidney disease; neurogenic bladder dysfunction; hypospadias).
Septic.
Positive blood culture (if contamination is not suspected).
Immune deficiency.
Systemic immunosuppressive therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naqash Sethi, MD
Phone
+4528405083
Email
naqash.javaid.sethi.02@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrikka Nygaard, Ass. prof, Ph.D.
Phone
+4535459761
Email
ulrikka.nygaard@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naqash Sethi, MD
Organizational Affiliation
Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrikka Nygaard, Ass. prof, Ph.D.
Organizational Affiliation
Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Copenhagen University Hospital Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Line Sehested, MD
Phone
+4523236326
Email
line.thousig.sehested.01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Ida Schmidt, Ph.D.
Phone
+4535450616
Email
ida.maria.schmidt@regionh.dk
First Name & Middle Initial & Last Name & Degree
Line Sehested, MD
First Name & Middle Initial & Last Name & Degree
Ida Schmidt, Ph.D.
First Name & Middle Initial & Last Name & Degree
Ulrikka Nygaard, Ass. prof., Ph.D.
Facility Name
Copenhagen University Hospital Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Christensen, MD
Phone
+4538685379
Email
mette.marie.christensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Mette Christensen, MD
Facility Name
Copenhagen University Hospital Hillerød
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Kai, Ph.D.
Phone
+4548296836
Email
claudia.mau.kai.03@regionh.dk
First Name & Middle Initial & Last Name & Degree
Claudia Kai, Ph.D.
Facility Name
Copenhagen University Hospital Holbæk
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe Sønderkær, MD
Phone
+4520875537
Email
ssok@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Signe Sønderkær, MD
Facility Name
Copenhagen University Hospital Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Cortes, Prof., DSMc
Phone
+4538626602
Email
dina.cortes@regionh.dk
First Name & Middle Initial & Last Name & Degree
Simone Markøw, MD
Phone
+4521574782
Email
mailto:simone.markoew@regionh.dk
First Name & Middle Initial & Last Name & Degree
Dina Cortes, Prof., DSMc
First Name & Middle Initial & Last Name & Degree
Simone Markøw, MD
Facility Name
Copenhagen University Hospital Nykøbing Falster
City
Nykøbing Falster
ZIP/Postal Code
4800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatjana Zaharov, MD
Phone
+4556515030
Email
tza@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Tatjana Zaharov, MD
Facility Name
Copenhagen University Hospital Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Jensen, MD, Ass. prof.
Phone
+4547324255
Email
lihje@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Maria Antonova, MD, ass. prof, Ph.D.
Phone
+4526802372
Email
maant@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Lise Jensen, MD, Ass. prof.
First Name & Middle Initial & Last Name & Degree
Maria Antonova, MD, ass. prof, Ph.D.
Facility Name
Copenhagen University Hospital Slagelse
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Line Wilms, Ass. prof., Ph.D.
Phone
+4530334330
Email
lkwl@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Maren Rytter, Ass. prof., Ph.D.
Phone
+4527280484
Email
mjry@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Line Wilms, Ass. prof., Ph.D.
First Name & Middle Initial & Last Name & Degree
Maren Rytter, Ass. prof., Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol and statistical analysis plan will be shared. Individual participant data (IPD) will be shared to facilitate the conduction of systematic reviews with meta-analysis of individual participant data.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Primarily for the conduction of individual participant data meta-analysis.
Learn more about this trial
Individualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infection
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