INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum a… (NCT07675018) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
France204 participantsStarted 2026-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of days with large broad-spectrum antibiotic therapy