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

Launched by UNIVERSITY HOSPITAL, LIMOGES · Sep 22, 2021

Keywords

ClinConnect Summary

The INVICTUS PED trial is studying a new way to treat urinary tract infections (UTIs) in children who come to the pediatric emergency department. The goal is to see if using a specific test that detects integrons in urine can help doctors choose a more targeted antibiotic treatment, which may be just as effective as the usual broad-spectrum antibiotics. This trial focuses on children aged 3 months to 17 years who have a suspected UTI with fever but are not severely ill.

To be eligible for this study, children must have their first episode of a UTI and show symptoms like fever and a positive urine test. Parents or guardians need to give written consent, and the child must be covered by Social Security. Participants in the trial will receive either the new tailored antibiotic treatment or the standard treatment and will be monitored to see which is more effective for helping them recover. It’s important to know that children with more serious health conditions or specific allergies may not be eligible to join this trial.

Gender

ALL

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