Status:
COMPLETED
Evaluation of Urine Samples Obtained by Bladder Stimulation for the Diagnosis of Urinary Tract Infection in Infants
Lead Sponsor:
Fondation Lenval
Conditions:
Urinary Tract Infection Bacterial
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
Urinary tract infection (UTI) is the most common serious bacterial infection among infants. Suprapubic aspiration and bladder catheterization are considered as the gold standard by the American Academ...
Detailed Description
Urinary tract infection (UTI) is common in infants and needs to be diagnosed quickly. The risk for urinary tract infection before the age of 2 years is about 1-4% in boys and 3-8% in girls. A delay in...
Eligibility Criteria
Inclusion
- Infants under the age of 6 months
- For whom an urine sample is required for the diagnosis of a urinary tract infection as follows:
- fever \> 39 °C without symptoms
- fever \> 38°C and uropathy or urinary tract infection
- fever \> 38°C and \< 3 months
- fever \> 38 °C and \> 48h
- fever \> 38 °C with sepsis signs
- Obtaining the authorization of the holders of parental authority
- Affiliation to French social security
Exclusion
- Do exhibiting signs of vital distress (respiratory or circulatory or neurological)
- contraindication to bladder catheterization
- antibiotic therapy in the last 48 hours
- antibiotic prophylaxis in the last 48 hours
Key Trial Info
Start Date :
December 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2023
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03801213
Start Date
December 12 2019
End Date
December 12 2023
Last Update
February 26 2024
Active Locations (4)
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1
CH Antibes Juans les Pins
Antibes, France
2
CH Grasse
Grasse, France
3
CHRU Lille
Lille, France
4
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, France