Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection
NCT ID: NCT05819229
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
125 participants
OBSERVATIONAL
2023-02-27
2025-05-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Oral antibiotic therapy
Clinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy.
Oral antibiotic therapy
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.
Interventions
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Oral antibiotic therapy
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.
Eligibility Criteria
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Inclusion Criteria
2. Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal).
3. 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.
* 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.
Exclusion Criteria
2. High-risk medical history.
1. Previous urinary tract infection.
2. Prophylactic antibiotic treatment.
3. 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).
4. Previous hospitalization needing antibiotic therapy.
3. Markedly elevated c-reactive protein indicating bacteremia.
4. Elevated creatinine.
5. Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).
4 Weeks
2 Months
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Ulrikka Nygaard
Principal investigator
Principal Investigators
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Naqash Sethi, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
Ulrikka Nygaard, Ass. prof, Ph.D.
Role: STUDY_CHAIR
Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
Locations
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Copenhagen University Hospital Rigshospitalet
Copenhagen, , Denmark
Copenhagen University Hospital Herlev
Herlev, , Denmark
Copenhagen University Hospital Hillerød
Hillerød, , Denmark
Copenhagen University Hospital Hvidovre
Hvidovre, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PO AB UTI
Identifier Type: -
Identifier Source: org_study_id
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