Actively Recruiting

Age: 4Weeks - 2Months
All Genders
NCT05819229

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

Led by Rigshospitalet, Denmark · Updated on 2024-07-08

125

Participants Needed

4

Research Sites

113 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

H

Hvidovre University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 4Weeks - 2Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical suspicion of urinary tract infection regardless of fever
  • Clinically stable without respiratory, circulatory, septic, or meningeal problems
  • Age 4 weeks to 2 months (corrected age if premature)
  • Positive urine culture with persistent urinary tract infection suspicion if no initial empirical antibiotics given
  • Urine culture definitions: any bacteria growth from suprapubic bladder aspiration; monoculture with 10^3 cfu/ml in sterile catheterization; or monoculture with defined colony counts in two midstream urine samples
Not Eligible

You will not qualify if you...

  • No Danish civil registration number
  • High-risk medical history including previous urinary tract infection, prophylactic antibiotics, known urogenital abnormalities (e.g. hydronephrosis, hydroureter, vesicoureteral reflux, renal dysplasia, neurogenic bladder, hypospadias)
  • Previous hospitalization requiring antibiotic therapy
  • Markedly elevated c-reactive protein indicating bacteremia
  • Elevated creatinine levels
  • Oral antibiotic therapy not possible due to frequent vomiting or excessive regurgitation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

Copenhagen University Hospital Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

2

Copenhagen University Hospital Herlev

Herlev, Denmark, 2730

Actively Recruiting

3

Copenhagen University Hospital Hillerød

Hillerød, Denmark, 3400

Actively Recruiting

4

Copenhagen University Hospital Hvidovre

Hvidovre, Denmark, 2650

Actively Recruiting

Loading map...

Research Team

N

Naqash Sethi, MD

CONTACT

U

Ulrikka Nygaard, Ass. prof, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here