An interventional study of integron research and usual practice in Urinary Tract Infections in Children, sponsored by University Hospital, Limoges. Terminated at 4 sites in France. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Basic science
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.
753 studies on the registry are indexed under Urinary Tract Infections; 127 are open to participants now.
This study's enrollment of 36 is below the median of 130 across 523 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Criteria of severity:
Complication risk factors:
Contra-indication to SXT:
Empirical antibiotic treatment chosen based on the results of the integron search: * when PCR is negative, patients will receive SXT (30 mg/kg/j of sulfamethoxazole and 6 mg/kg/j of trimethoprim) * when PCR is positive or uninterpretable for integrons, patients will receive an empirical antibiotic treatment based on the usual practice of each center according to the GPIP guidelines.
Procedure: integron research
Empirical antibiotic treatment based on the usual practice of each center according to the GPIG guidelines.
Procedure: usual practice
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.
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.
Recovery
Recovery defined as, apyrexia obtained within less than 72h and no persistence or repetition of UTI with fever and no change of empirical antibiotic therapy required because of resistance and no treatment interruption for adverse effects
Time frame: Day 30
patients treated
Number of patients treated with 3GC in both groups, during the participation of each patient
Time frame: Day 30
Duration treatment
Duration of treatment with 3GC in both groups for patient treated, during the participation of each patient
Time frame: Day 30
Antibiotic treatment changes
In both groups, description of antibiotic treatment changes based on the AST results, according to 4 criteria: * Change because of resistance * Narrowing of the antibiotic spectrum * Interruption because the diagnosis of UTI was ruled out * Antibiotics used
Time frame: Hour 48
Adaptation of antibiotherapy with the AST result
Proportion of patients in both groups for whom empirical antibiotic treatment was adapted to the AST results and did not require any change (because of resistance, or to narrow the antibiotic spectrum)
Time frame: Hour 48
Resistance of enterobacteria
In the study population, percentage of resistance of enterobacteria to the different antibiotic classes
Time frame: Hour 48
Predictive values of the integrons
Negative and positive predictive values of the integrons depending on the main antibiotic classes used in the experimental group.
Time frame: Hour 48
Apyrexia
Time to apyrexia from the start of the antibiotic therapy compared between both groups.
Time frame: Hour 48
Early repetition of urinary tract infection
Proportion of early repetition of urinary tract infection with fever in both groups.
Time frame: Day 30
Treatment interruption for adverse effects
Proportion of treatment interruption for adverse effects in both groups.
Time frame: Day 30
Time spent in the pediatric emergency department
Time spent in the pediatric emergency department in both groups
Time frame: Day 30
This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Limoges