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NCT Number: NCT07675018

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Tours, Hôpital Trousseau, Chambray-lès-Tours, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Number of days with large broad-spectrum antibiotic therapy

    Time frame: Day 7

    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

Secondary outcomes

  1. Proportion of patients with clinical resolution of UTI

    Time frame: Day 7

    Proportion of patients with clinical resolution of UTI, i.e. 2 consecutive temperature assessment < 38°C and ≥ 36°C (with a minimum interval of 3 hours) within the first 48 hours after the first parenteral antibiotic administration

  2. Proportion of patients for whom the empirical antibiotic therapy

    Time frame: Day 7

    Proportion of patients for whom the empirical antibiotic therapy was adapted to the AST

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

    Time frame: Day 7

    Proportion of patients, in the experimental arm, for whom the integron detection result was consistent with the AST (i.e., true positives + true negatives, AST being the gold standard)

  4. Proportion of resistant bacteria for the clinically-relevant antibiotics

    Time frame: Day 7

    Proportion of resistant bacteria for the clinically-relevant antibiotics (AST data)

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier BARRAUD, MD

CONTACT

[email protected]

055505665 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study 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

Acronym: INVICTUS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 30, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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