Using integron tests to guide first-line antibiotics for non-severe UTI in adults

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 multicenter prospective trial explores whether a molecular test for integrons can guide initial antibiotic therapy for adults with non-severe UTIs. In the experimental arm, positive integron detection leads clinicians to use broad-spectrum options; negative results lead to a narrower, cephalosporin-based approach. The study builds on prior data showing high negative predictive value of integrons for resistance, aiming to reduce unnecessary use of broad-spectrum antimicrobials. Eligible patients are adults with non-severe UTI, fever criteria, documented prior 3GC-resistant bacteria, and requiring parenteral therapy. Outcomes will compare empirical therapy choices and antibiotic exposure between the integron-guided and standard empiric therapy approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years old; Hospitalized or admitted to the Emergency department;
* Diagnosis of non-severe (qSOFA \< 2) urinary tract infection coupled with fever ≥ 38°C or \< 36°C
* Presence of bacteria in the fresh urine sample and/or GNB on the Gram stain
* Empirical parenteral antibiotic therapy required; Hospitalization required;
* Former documentation of a 3GC-resistant GNB on a microbiological sample in the previous six months
* Informed consent of the patient or their representative

Exclusion Criteria:

* Pregnant and/or breastfeeding
* Neutropenia (absolute neutrophil count \< 500 / mm3)
* Severe UTI with sepsis (qSOFA ≥ 2) or septic shock
* Urinary derivation required (ureteral catheter/per-cutaneous nephrostomy) except for simple urinary catheterization
* Known allergy to β-lactams
* Patients with a former documentation with carbapenemase-producing Enterobacterales in the last 6 months
* Ongoing antibiotic treatment with 3GC, piperacillin-tazobactam or carbapenem
* Not affiliated to Social Security

Where it's running

• Limoges university hospital
  Limoges, France Recruiting
• CHRU Tours, Hôpital Trousseau
  Chambray-lès-Tours, France Not yet recruiting
• Grenoble university hospital
  La Tronche, France Not yet recruiting
• Hopital lariboisière
  Paris, France Not yet recruiting
• Hôpital Saint Louis - APHP
  Paris, France Not yet recruiting
• Groupe Hospitalier Universitaire Bichat-Claude Bernard - APHP
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Olivier BARRAUD, MD
• Email: olivier.barraud@chu-limoges.fr
• Phone: 055505665

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How HIV Treatment Changes Affect Hidden Drug Resistance

  Researchers will see if changing HIV treatment in people with fully suppressed virus reveals hidden drug resistance in proviral DNA.

  Recruiting Chinese University of Hong Kong · Hong Kong, Hong Kong · NCT07643948

• Customizable antibiotic stewardship for French nursing homes

  This study tests a customizable antibiotic stewardship program to see if it improves antimicrobial use in French nursing homes.

  Recruiting at 2 sites University of Lorraine · Nantes and 1 other locations · NCT07246382

• Assessing treatments for difficult-to-treat Pseudomonas infections

  This study is testing different antibiotic treatments for tough Pseudomonas infections to see which ones work best for patients needing intravenous therapy.

  Recruiting at 4 sites Centre Hospitalier Régional d'Orléans · Amiens and 47 other locations · NCT06738771

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.