Urinary Tract Infections in Children Clinical Trial
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
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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04278404 -
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
|
||
| Recruiting |
NCT04654507 -
Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children
|
Phase 3 | |
| Completed |
NCT03263845 -
Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness
|
N/A | |
| Completed |
NCT06109688 -
Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.
|
Phase 3 | |
| Recruiting |
NCT04608851 -
Preventing Urinary Tract Infections With E. Coli Nissle:
|
Phase 4 | |
| Recruiting |
NCT03825874 -
Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
|
||
| Withdrawn |
NCT06273098 -
School-Based Bladder Health Intervention
|
N/A | |
| Recruiting |
NCT03221504 -
7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children
|
N/A | |
| Recruiting |
NCT05819229 -
Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection
|
||
| Terminated |
NCT04763967 -
A Study of the PedSCath Pediatric Sampling Catheter Versus Current Standard of Care.
|
||
| Completed |
NCT04066621 -
PHase IV Clinical Trial of Ceftriaxone Sodium and Sulbactam Sodium for Injection (CRO-SBT)
|
Phase 4 |