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NCT07675018
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Conditions: Drug Resistance, Microbial, Biomarkers, Urinary Tract Infections (UTI's), Antibacterial Agents
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 204
Sponsor: University Hospital, Limoges
Location: CHRU Tours, Hôpital Trousseau Chambray-lès-Tours
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\
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
Source: ClinicalTrials.gov (NCT07675018). StuddyBuddy aggregates publicly available trial information.