NCT05066854

INterest of the Negative Predictive Value of Integrons in Choosing a Narrow-spectrum Empirical anTibiotic Treatment vs Usual Empirical Antibiotic Treatment for Urinary Tract infectionS in the PEDiatric Emergency Department

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

INVICTUS PED primary objective is to show the non-inferiority of an empirical antibiotic therapeutic management guided by the early detection of integrons in the urine, compared to a usual empirical antibiotic treatment, for the recovery of children admitted to the pediatric emergency department (ED) with a non-severe urinary tract infection (UTI) with fever

Detailed description

Urinary tract infections with fever are common in children and require primary health care management. Because of the risk of immediate evolution to a systemic infection with long-term renal scars, empirical antibiotic treatment is recommended. The French Group for Pediatric Infectious Diseases (GPIP) recommends the use of third-generation cephalosporins (3GC) targeting enterobacteria, which are mainly involved in UTI and increasingly resistant to antibiotics through the production of extended-spectrum β-lactamases. However, use of 3GC is a well-known risk factor for resistant germs selection and one of the main guideline to fight antibiotic resistance, which is an important public health issue, is to reduce their use. Integrons are genetic elements involved in the spread of antibiotic resistance in enterobacteria. Preliminary studies showed that integron search using polymerase chain reaction (PCR) directly on urine samples had a great NPV (\>98%) for trimethoprim-sulfamethoxazole (SXT). The hypothesis is that, in children presenting to the pediatric ED with non-severe UTI with fever, absence of integron in their urine could allow prescribing an empirical antibiotic treatment with SXT without decreasing the chance of recovery, thus decreasing the use of 3GC. Two strategies is compare: i) In the control group: empirical antibiotic treatment according to the usual practice of each center, in line with the GPIP guidelines, ii) in the experimental group: empirical antibiotic treatment chosen depending on the results of the integron search with PCR. When PCR is positive, treatment according to usual practice; when PCR is negative, treatment with SXT. Two follow-up visits, by phone, will be planned: at H48 (+ 24h), when the empirical antibiotic treatment is assessed based on the urine culture and antimicrobial susceptibility test (AST) results, and on D30 (+/- 2 days) at the end of the follow-up.

Conditions

• Urinary Tract Infections in Children

Interventions

Type	Name	Description
PROCEDURE	integron research	Patients with suspected UTI with fever will be screened at their admission to the pediatric ED. Urine samples will be sent to the laboratory for culture and integron PCR according to routine practice. Results of the integron search will be given to the investigator. Patients in the experimental group with a positive or uninterpretable PCR will also receive an empirical antibiotic treatment based on the usual practice of each center according to the GPIP guidelines. Patients in the experimental group with a negative PCR will receive a treatment with SXT at the recommended dose.
PROCEDURE	usual practice	Patients with suspected UTI with fever will be screened at their admission to the pediatric ED. Patients in the control group will receive an empirical antibiotic treatment based on the usual practice of each center according to the GPIP guidelines.

Timeline

• Start date: 2022-10-18
• Primary completion: 2025-11-17
• Completion: 2025-11-17
• First posted: 2021-10-04
• Last updated: 2025-11-26

Locations

4 sites across 1 country: France