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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: christine.laguille@chu-limoges.fr
• Phone: 0555058664

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.