Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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