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.
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;
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
Parallel
Detection of integrons
Diagnostic testEmpirical 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 interventionThe 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
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
Proportion of patients with clinical resolution of UTI
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
Proportion of patients for whom the empirical antibiotic therapy
Proportion of patients for whom the empirical antibiotic therapy was adapted to the AST
Proportion of patients, for whom the integron detection result was consistent with the AST
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)
Proportion of resistant bacteria for the clinically-relevant antibiotics
Proportion of resistant bacteria for the clinically-relevant antibiotics (AST data)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
