Oral antibiotics for young children with urinary tract infections
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.
This study is testing if giving oral antibiotics alone is safe and effective for young children with urinary tract infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 4 Weeks to 2 Months |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 4 sites (Copenhagen and 3 other locations) |
| Trial ID | NCT05819229 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and feasibility of using oral antibiotic therapy alone in clinically stable children aged 4 weeks to 2 months who have a suspected or confirmed urinary tract infection. Children will be monitored by healthcare professionals according to established guidelines, and those requiring empirical antibiotic treatment will be admitted for observation. If a urinary tract infection is confirmed, oral antibiotics will be initiated, while ensuring that any deterioration in the child's condition will prompt a switch to parenteral therapy. The study will help determine the effectiveness of oral antibiotics in this young population.
Who should consider this trial
Good fit: Ideal candidates for this study are clinically stable infants aged 4 weeks to 2 months with a suspected urinary tract infection and no high-risk medical history.
Not a fit: Patients with a high-risk medical history or those who are clinically unstable will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify the treatment of urinary tract infections in young children, reducing the need for hospitalization and intravenous antibiotics.
How similar studies have performed: While there have been studies on antibiotic treatments for urinary tract infections, this specific approach focusing on young infants is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: 1. Clinical suspicion of urinary tract infection irrespective of the presence of fever. 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: 1. Non-Danish civil registration number. 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).
Where this trial is running
Copenhagen and 3 other locations
- Copenhagen University Hospital Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Copenhagen University Hospital Herlev — Herlev, Denmark (Recruiting)
- Copenhagen University Hospital Hillerød — Hillerød, Denmark (Recruiting)
- Copenhagen University Hospital Hvidovre — Hvidovre, Denmark (Recruiting)
Study contacts
- Principal investigator: Naqash Sethi, MD — Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
- Study coordinator: Naqash Sethi, MD
- Email: naqash.javaid.sethi.02@regionh.dk
- Phone: +4528405083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.