Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05066854
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2021-09-16
Brief Title:
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
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INVICTUS PED
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None