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Clinical Trials in France / NCT07675018
Starting soon Not applicable

INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS

NCT07675018 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-09-15
Last updated
2026-07-01

Condition(s) studied

Drug Resistance, MicrobialBiomarkersUrinary Tract Infections (UTI's)Antibacterial Agents

Investigational drug(s) / intervention(s)

Detection of integronsGold standard

Detection of integrons: Empirical parenteral antibiotic therapy will be guided based on the detection of integrons. If integrons detection is positive, a large broad spectrum therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) will be prescribed. If integrons detection is negative, patient will receive a parenteral 3GC (ceftriaxone, cefotaxime, ceftazidime or cefepime). The treatment will be started after the integron detection.

Gold standard: The comparative treatment will be an empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) at clinician's discretion. The treatment will be started after the randomization

Study summary

Urinary tract infections (UTI), mainly driven by Gram-negative bacteria (GNB) are a frequent cause of hospitalization and the second cause of antibiotic prescription after lower respiratory tract infections. Integrons play a major role in the dissemination of antibiotic resistance among GNB. In the prospective INVICTUS project, whose ultimate objective is to reduce the use of large broad-spectrum antibiotics, our hypothesis is that, in adult patients with a non-severe UTI (qSOFA\<2) and a former documentation with a 3GC-resistant GNB in the previous 6 months, integrons search could reduce the empirical use of large broad-spectrum antibiotics.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
CHRU Tours, Hôpital Trousseau Chambray-lès-Tours France
Grenoble university hospital La Tronche France
Limoges university hospital Limoges France
Hopital lariboisière Paris France
Hôpital Saint Louis - APHP Paris France
Groupe Hospitalier Universitaire Bichat-Claude Bernard - APHP Paris France
CHU de Reims Reims France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07675018 on ClinicalTrials.gov ↗ ← All trials in France