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

NCT05066854 | Terminated

• 1 other identifier: 87RI20_0029 (INVICTUS PED)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

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

Conditions

Urinary Tract Infections in Children

Keywords

empirical antibiotic treatment; biomarker; urinary tract infection; antibiotic resistance; pediatric emergency department

Outcome Measures

Primary Outcomes (1)

• 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

  Day 30

Secondary Outcomes (10)

• patients treated

  Day 30

• Duration treatment

  Day 30

• Antibiotic treatment changes

  Hour 48

• Adaptation of antibiotherapy with the AST result

  Hour 48

• Resistance of enterobacteria

  Hour 48

Study Arms (2)

Integron research

EXPERIMENTAL

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

Usual practice

OTHER

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

Procedure: usual practice

Interventions

integron research 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.

Integron research

usual practice 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.

Usual practice

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• GC allergy
• Contra-indication to SXT:

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (4)

Bordeaux university Hospital

Bordeaux, 33000, France

Location

Limoges university Hospital

Limoges, 87042, France

Location

Montpellier university Hospital

Montpellier, 34000, France

Location

Toulouse university Hospital

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 4, 2021
• Study Start: October 18, 2022
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

FR (4)