Urinary Tract Infections in ChildrenNCT05819229
Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection
An observational study of Urinary Tract Infections in Children, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
Trial summary
The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection. Read more about this study
- Who is it for?
- Ages 4 weeks to 2 months
- Conditions the study is for
- Urinary Tract Infections in Children
- What is being tested?
- Oral antibiotic therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 125 participants
- Where
- 4 sitesDenmark
- Study dates
- 27 Feb 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 2 months
- All sexes
- No healthy volunteers
- Child
Study population: All children aged 4 weeks to 2 months who are referred by their primary physician or the medical helpline 1813 (outside the work hours of their primary physician) to one of four pediatric emergency departments in the Capital Region of Denmark with suspected urinary tract infection.
Who may be able to join
- Clinical suspicion of urinary tract infection irrespective of the presence of fever.
- Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal).
- 4 weeks to 2 months of age (corrected age, if premature).
- All children who do not receive any empirical antibiotic therapy but have a positive urine culture can be included if the clinical suspicion of urinary tract infection persists.
- A positive urine culture is defined as:
- Suprapubic bladder aspiration: any growth of bacteria.
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- Sterile intermittent catheterization: monoculture with ≥10^3 colony forming units per milliliter (cfu/ml).
- Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10^4 cfu/ml.
- Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10^5 cfu/ml in one test and 10^3 cfu/ml in another test.
Who cannot join
- Non-Danish civil registration number.
- High-risk medical history.
- Previous urinary tract infection.
- Prophylactic antibiotic treatment.
- Known urogenital abnormality (i.e., hydronephrosis (pyelectasis ≥10 mm or/and caliectasis ≥5 mm); hydroureter; vesicoureteral reflux; multicystic dysplasia; renal dysplasia; renal hypoplasia; renal agenesis; duplex kidney; ectopic placed kidneys; polycystic kidney disease; neurogenic bladder dysfunction; and hypospadias).
- Previous hospitalization needing antibiotic therapy.
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- Markedly elevated c-reactive protein indicating bacteremia.
- Elevated creatinine.
- Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites, 4 recruiting
- Recruiting
Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Line Sehested, MD, 35455220, line.thousig.sehested.01@regionh.dk
- Recruiting
Copenhagen University Hospital Herlev
Herlev, 2730
Mette Christensen, MD, +4538685379, mette.marie.christensen@regionh.dk
- Recruiting
Copenhagen University Hospital Hillerød
Hillerød, 3400
Claudia Kai, Ph.D., +4548296836, claudia.mau.kai.03@regionh.dk
- Recruiting
Copenhagen University Hospital Hvidovre
Hvidovre, 2650
Dina Cortes, Prof., DSMc, +4538626602, dina.cortes@regionh.dk
About this study
Official title: Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Suspected or Confirmed Uncomplicated Urinary Tract Infection. A Single-arm Multicenter Prospective Observational Study.
The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.
Read the detailed description
All children aged 4 weeks to 2 months with a suspected urinary tract infection will be observed and examined by physicians and nurses as recommended by current guidelines. Children needing empirical antibiotic therapy will be admitted. The remaining will be contacted by phone if the urine culture is positive, and antibiotic therapy will be initiated if a urinary tract infection is still suspected due to persistent symptoms.
Clinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy. As empirical oral therapy, amoxicillin-clavulanic acid 50 mg/kg/day divided into 3 doses will be used. If the sensitivity pattern is available, a smaller-spectrum antibiotic can be used instead. If these children at any time point become clinically unstable or have a positive blood culture without suspected contamination, parenteral antibiotic therapy will be initiated. As empirical parenteral therapy, gentamicin 5 mg/kg once daily and ampicillin 100 mg/kg/day divided into 3 doses will be used. If the sensitivity pattern is available, another parenteral antibiotic regime can be used instead.
Admitted children can be sent home when they have clinically improved (judged by the physician) and have been hospitalized at least until the ward round the following day. Parents will be informed to contact the pediatric emergency department immediately if the child worsens or does not tolerate the antibiotics.
A physical or virtual follow-up will be conducted on day 3 (approximately 72 hours after treatment initiation) to ensure clinical improvement and treatment adherence. If needed, antibiotic therapy will be changed according to the sensitivity pattern. Children with a negative urine culture will be informed to stop antibiotic therapy.
The duration of antibiotic therapy will be 10 days. All children will undergo a renal ultrasound within the treatment period.
The above recommendations has been implemented as routine care. Hence, no parental consent is needed.
- Conditions
- Urinary Tract Infections in Children
- Being tested
- Oral antibiotic therapy
- Keywords
- Antibiotic therapy, Urinary tract infection, Children
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral antibiotic therapyDrug
Empirical choice: amoxicillin-clavulanic acid 50 mg/kg/day divided into three doses.
If the sensitivity pattern is available, another oral antibiotic, preferably smaller-spectrum, can be used instead.
Total duration of antibiotic therapy will be 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Oral antibiotic therapy | Clinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy. Receives: Drug: Oral antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Measured: Within 28 days after end of treatment
Number of days admitted related to urinary tract symptoms
Measured: Within 28 days after treatment initiation
Secondary outcomes (3)
Number of days with antibiotic-related non-serious adverse events.
Data on diarrhea, loss of appetite, and vomiting will be included.
Measured: From date of treatment initiation until the date of treatment stop for the baseline infection, assessed up to 14 days
Proportion of participants with a recurrent urinary tract infection regardless of the pathogen or death of any cause.
Measured: Within 100 days after end of treatment
Proportion of participants with a recurrent infection with a bacterium resistant to the antibiotic given for the baseline infection or an opportunistic infection
Measured: Within 100 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start27 Feb 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infections in ChildrenStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Ulrikka Nygaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Naqash Sethi, MD, Principal investigator, Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, DenmarkUlrikka Nygaard, Ass. prof, Ph.D., Study chair, Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819229
- Sponsor's protocol ID
- PO AB UTI
- Status last verified
- Jul 2024
- First submitted
- 22 Feb 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan will be shared. Individual participant data will be shared to facilitate the conduction of research or quality improvement projects.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Suspected or Confirmed Uncomplicated Urinary Tract Infection. A Single-arm Multicenter Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05819229
- Acronym / sponsor ID
- PO AB UTI
- Conditions
- Urinary Tract Infections in Children
- Keywords
- Antibiotic therapy, Urinary tract infection, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.
Detailed description
All children aged 4 weeks to 2 months with a suspected urinary tract infection will be observed and examined by physicians and nurses as recommended by current guidelines. Children needing empirical antibiotic therapy will be admitted. The remaining will be contacted by phone if the urine culture is positive, and antibiotic therapy will be initiated if a urinary tract infection is still suspected due to persistent symptoms.
Clinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy. As empirical oral therapy, amoxicillin-clavulanic acid 50 mg/kg/day divided into 3 doses will be used. If the sensitivity pattern is available, a smaller-spectrum antibiotic can be used instead. If these children at any time point become clinically unstable or have a positive blood culture without suspected contamination, parenteral antibiotic therapy will be initiated. As empirical parenteral therapy, gentamicin 5 mg/kg once daily and ampicillin 100 mg/kg/day divided into 3 doses will be used. If the sensitivity pattern is available, another parenteral antibiotic regime can be used instead.
Admitted children can be sent home when they have clinically improved (judged by the physician) and have been hospitalized at least until the ward round the following day. Parents will be informed to contact the pediatric emergency department immediately if the child worsens or does not tolerate the antibiotics.
A physical or virtual follow-up will be conducted on day 3 (approximately 72 hours after treatment initiation) to ensure clinical improvement and treatment adherence. If needed, antibiotic therapy will be changed according to the sensitivity pattern. Children with a negative urine culture will be informed to stop antibiotic therapy.
The duration of antibiotic therapy will be 10 days. All children will undergo a renal ultrasound within the treatment period.
The above recommendations has been implemented as routine care. Hence, no parental consent is needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral antibiotic therapy | – | Drug: Oral antibiotic therapyClinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy. |
Who may qualify
- Ages
- 4 weeks to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children aged 4 weeks to 2 months who are referred by their primary physician or the medical helpline 1813 (outside the work hours of their primary physician) to one of four pediatric emergency departments in the Capital Region of Denmark with suspected urinary tract infection.
Key inclusion criteria (9 listed)
- Clinical suspicion of urinary tract infection irrespective of the presence of fever.
- Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal).
- 4 weeks to 2 months of age (corrected age, if premature).
- All children who do not receive any empirical antibiotic therapy but have a positive urine culture can be included if the clinical suspicion of urinary tract infection persists.
- Suprapubic bladder aspiration: any growth of bacteria.
Key exclusion criteria (9 listed)
- Non-Danish civil registration number.
- High-risk medical history.
- Markedly elevated c-reactive protein indicating bacteremia.
- Elevated creatinine.
- Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral antibiotic therapyEmpirical choice: amoxicillin-clavulanic acid 50 mg/kg/day divided into three doses. If the sensitivity pattern is available, another oral antibiotic, preferably smaller-spectrum, can be used instead. Total duration of antibiotic therapy will be 10 days. | Drug | Oral antibiotic therapy |
Primary outcome
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
Number of days admitted related to urinary tract symptoms
Time frame: Within 28 days after treatment initiation
3 secondary outcomes
Number of days with antibiotic-related non-serious adverse events.
Time frame: From date of treatment initiation until the date of treatment stop for the baseline infection, assessed up to 14 days
Proportion of participants with a recurrent urinary tract infection regardless of the pathogen or death of any cause.
Time frame: Within 100 days after end of treatment
Proportion of participants with a recurrent infection with a bacterium resistant to the antibiotic given for the baseline infection or an opportunistic infection
Time frame: Within 100 days after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan will be shared. Individual participant data will be shared to facilitate the conduction of research or quality improvement projects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naqash Sethi, MD principal investigator
Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
Ulrikka Nygaard, Ass. prof, Ph.D. study chair
Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections in Children, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naqash Sethi, MD (+4528405083, naqash.javaid.sethi.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.