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

NCT07675018 | Not Yet Recruiting

• 3 other identifiers: 87RI19_0037 (INVICTUS)ReCH-MIE-24-0032026-A00508-43
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

Integron; Antimicrobial Stewardship; Antimicrobial Resistance; Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Number of days with large broad-spectrum antibiotic therapy

  Number of days with large broad-spectrum antibiotic therapy (ureidopenicillin and β-lactamases inhibitor combinations or carbapenems) during the first week of treatment (i.e., until Day 7 after admission) in the experimental arm compared to the number of days with large broad-spectrum antibiotic therapy in the control arm

  Day 7

Secondary Outcomes (4)

• Proportion of patients with clinical resolution of UTI

  Day 7

• Proportion of patients for whom the empirical antibiotic therapy

  Day 7

• Proportion of patients, for whom the integron detection result was consistent with the AST

  Day 7

• Proportion of resistant bacteria for the clinically-relevant antibiotics

  Day 7

Study Arms (2)

Empirical parenteral antibiotic therapy based on the detection of integrons

EXPERIMENTAL

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). The treatment will be started after the integron detection

Diagnostic Test: Detection of integrons

Empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations

ACTIVE COMPARATOR

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. The treatment will be started after the randomization

Other: Gold standard

Interventions

Detection of integrons DIAGNOSTIC_TEST

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.

Empirical parenteral antibiotic therapy based on the detection of integrons

Gold standard OTHER

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

Empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (7)

CHRU Tours, Hôpital Trousseau

Chambray-lès-Tours, 37170, France

Location

Grenoble university hospital

La Tronche, 38700, France

Location

Limoges university hospital

Limoges, 87042, France

Location

Hopital lariboisière

Paris, 75010, France

Location

Hôpital Saint Louis - APHP

Paris, 75010, France

Location

Groupe Hospitalier Universitaire Bichat-Claude Bernard - APHP

Paris, 75018, France

Location

CHU de Reims

Reims, 51100, France

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Olivier BARRAUD, MD

CONTACT

055505665; olivier.barraud@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, controlled, open, trial

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 21, 2028
• Study Completion (Estimated): September 21, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)