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Individualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infection

NCT05301023 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2024-07-08

No results posted yet for this study

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.

Conditions

  • Febrile Urinary Tract Infection

Interventions

OTHER

Individualized antibiotic therapy

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.

OTHER

Standard antibiotic therapy

Standard antibiotic therapy is 10 days of antibiotic therapy regardless of the duration of illness after treatment initiation.

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-02-29
Completion
2024-06-08

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 NCT05301023 on ClinicalTrials.gov