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ClinicalTrials.gov ID

NCT07675018

Lead Sponsor

University Hospital, LimogesOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

204Estimated

Last Update Posted

Jul 1, 2026Actual

Start Date

Sep 15, 2026Estimated

Primary Completion Date

Sep 21, 2028Estimated

Completion Date

Sep 21, 2028Estimated

Official Title

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

Brief 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.

Detailed Description

The promotor conducted a multicenter prospective study, IRIS (Interest of integrons as predictive markers of acquired antibiotic Resistance in patients with urinary or Intra-abdominal Sepsis) which showed that integrons have a high negative predictive value (NPV) for antibiotic resistance. Among the 343 patients admitted in the ED or intensive care units (ICU) with a urinary sepsis, the NPV of integrons, by detecting them directly form urine samples, was 96.6% (CI:94.0-98.6%) for resistance to 3GC. Whether the detection of integrons to predict antibiotic resistance could efficiently guide empirical antibiotic therapy of patients with a UTI remains to determine. INVICTUS aims at providing the front-line ED physician with additional valuable information using molecular detection of integrons, to best guide adequate first-line antibiotic therapy, while sparing large broad-spectrum antimicrobial agents. In the experimental arm, 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). In the control arm, 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. For the primary analysis, the number of days with large broad-spectrum antibiotic therapy during the first week will be compared between the two groups using a Student t-test.

• Drug Resistance, Microbial
• Biomarkers
• Urinary Tract Infections (UTI's)
• Antibacterial Agents

• Detection of integrons
• Gold standard

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, LimogesOTHER

olivier.peyrony@aphp.fr0667986515 ext. +33

sgennai@chu-reims.fr0326832565