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Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection

NCT05819229 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2024-07-08

No results posted yet for this study

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.

Conditions

  • Urinary Tract Infections in Children

Interventions

DRUG

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.

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Naqash Sethi, MD · Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark

  • Ulrikka Nygaard, Ass. prof, Ph.D. · Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark

Eligibility

Min Age
4 Weeks
Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2025-04-01
Completion
2025-05-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05819229 on ClinicalTrials.gov