Using integrons to guide antibiotic treatment for urinary tract infections in children

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

This study is testing if using a special urine test to guide antibiotic treatment can help children with urinary tract infections just as well as the usual antibiotics, while also helping to reduce antibiotic resistance.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 232 (estimated)
• Ages: 3 Months to 18 Years
• Sex: All
• Sponsor: University Hospital, Limoges (other)
• Drugs / interventions: methotrexate
• Locations: 4 sites (Bordeaux and 3 other locations)
• Trial ID: NCT05066854 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of using integron detection in urine samples to guide antibiotic treatment for children with non-severe urinary tract infections (UTIs) presenting to pediatric emergency departments. The primary objective is to demonstrate that an empirical treatment based on integron results is non-inferior to standard antibiotic treatment recommended by guidelines. By potentially allowing the use of trimethoprim-sulfamethoxazole instead of broader-spectrum antibiotics, the study seeks to reduce antibiotic resistance. The study will compare two treatment strategies: the usual practice and the integron-guided approach.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 months to 18 years with a first episode of urinary tract infection with fever.

Not a fit: Patients with severe infections, dehydration, or anatomical defects of the urinary tract may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more targeted antibiotic treatments, reducing the risk of antibiotic resistance in children.

How similar studies have performed: Preliminary studies have shown promising results with integron detection, indicating potential for success in this novel approach.

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

Where this trial is running

Bordeaux and 3 other locations

• Bordeaux university Hospital — Bordeaux, France (RECRUITING)
• Limoges university Hospital — Limoges, France (RECRUITING)
• Montpellier university Hospital — Montpellier, France (RECRUITING)
• Toulouse university Hospital — Toulouse, France (RECRUITING)

Study contacts

• Study coordinator: Christine LAGUILLE, MD

Conditions: Urinary Tract Infections in Children, empirical antibiotic treatment, biomarker, urinary tract infection, antibiotic resistance, pediatric emergency department