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

NCT ID: NCT05066854

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2025-11-17

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.

Conditions

Urinary Tract Infections in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Integron research

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.

Group Type: EXPERIMENTAL

integron research

Intervention Type: PROCEDURE

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.

Usual practice

Empirical antibiotic treatment based on the usual practice of each center according to the GPIG guidelines.

Group Type: OTHER

usual practice

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Children above 3 months old and under 18 years old
• Consultation in a participating pediatric emergency department
• Suspicion of UTI with fever (Fever ≥ 38°C and urine dipstick test positive for leukocytes and/or nitrites)
• First episode of UTI with fever
• Written informed consent of the holders of parental authority
• Affiliated to Social Security

Exclusion Criteria

• Criteria of severity:

• Severe infection with severe sepsis or septic shock
• Dehydration ≥ 10%
• Fever ≥ 38°C > 4 days (96h)
• Indication of surgical or interventional drainage
• Complication risk factors:

• Any anatomic or functional defect of the urinary tract (other than low-grade VUR and calyceal dilation < 10 mm)
• Repetition of UTI with fever ≤ than 6 months since the previous episode
• Repetition of UTI with fever and anatomic or functional defect of the urinary tract
• Pregnancy
• Severely immunocompromised patient
• Severe chronic renal failure defined as a clearance < 30 mL/min/1.73 m2
• Severe liver failure
• 3GC allergy
• Contra-indication to SXT:

• G6PD deficiency
• Treatment with methotrexate
• Allergy to sulfonamide
• Antibiotic treatment within 48h before admission
• Empirical antibiotic treatment not recommended

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bordeaux university Hospital

Bordeaux, , France

Limoges university Hospital

Limoges, , France

Montpellier university Hospital

Montpellier, , France

Toulouse university Hospital

Toulouse, , France

Countries

France

Other Identifiers

87RI20_0029 (INVICTUS PED)

Identifier Type: -

Identifier Source: org_study_id