[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644961":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":124,"collaborators":26,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":26,"enrollmentInfo":136,"targetDuration":26,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":148,"overallStatus":153,"whyStopped":26,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"University Hospital, Limoges","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Diagnostic Test: Detection of integrons",{"label":15,"type":16,"description":17,"interventionNames":18},"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",[19],"Other: Gold standard",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Detection of integrons","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.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Gold standard","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",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Olivier BARRAUD, MD","CONTACT","055505665","+33","olivier.barraud@chu-limoges.fr",[39,58,67,76,85,97,109],{"facility":40,"status":26,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"CHRU Tours, Hôpital Trousseau","Chambray-lès-Tours","37170","France","FR",{"type":46,"coordinates":47},"Point",[48,49],0.70286,47.33537,{"lat":49,"lon":48},[52,56],{"name":53,"role":34,"phone":54,"phoneExt":36,"email":55},"Geoffroy ROUSSEAU, MD","0247474747","geoffroy.rousseau@chu-tours.fr",{"name":53,"role":57,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":59,"status":26,"city":60,"state":26,"zip":61,"country":43,"countryCode":44,"cosmosGeoPoint":62,"geoPoint":66,"contacts":26},"Grenoble university hospital","La Tronche","38700",{"type":46,"coordinates":63},[64,65],5.74629,45.20507,{"lat":65,"lon":64},{"facility":68,"status":26,"city":69,"state":26,"zip":70,"country":43,"countryCode":44,"cosmosGeoPoint":71,"geoPoint":75,"contacts":26},"Limoges university hospital","Limoges","87042",{"type":46,"coordinates":72},[73,74],1.24759,45.83362,{"lat":74,"lon":73},{"facility":77,"status":26,"city":78,"state":26,"zip":79,"country":43,"countryCode":44,"cosmosGeoPoint":80,"geoPoint":84,"contacts":26},"Hopital lariboisière","Paris","75010",{"type":46,"coordinates":81},[82,83],2.3488,48.85341,{"lat":83,"lon":82},{"facility":86,"status":26,"city":78,"state":26,"zip":79,"country":43,"countryCode":44,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Hôpital Saint Louis - APHP",{"type":46,"coordinates":88},[82,83],{"lat":83,"lon":82},[91,95],{"name":92,"role":34,"phone":93,"phoneExt":36,"email":94},"Olivier Peyrony, MD","0667986515","olivier.peyrony@aphp.fr",{"name":96,"role":57,"phone":26,"phoneExt":26,"email":26},"Olivier PEYRONY, MD",{"facility":98,"status":26,"city":78,"state":26,"zip":99,"country":43,"countryCode":44,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"Groupe Hospitalier Universitaire Bichat-Claude Bernard - APHP","75018",{"type":46,"coordinates":101},[82,83],{"lat":83,"lon":82},[104,108],{"name":105,"role":34,"phone":106,"phoneExt":36,"email":107},"Christophe CHOQUET, MD","0140256012","christophe.choquet@aphp.fr",{"name":105,"role":57,"phone":26,"phoneExt":26,"email":26},{"facility":110,"status":26,"city":111,"state":26,"zip":112,"country":43,"countryCode":44,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"CHU de Reims","Reims","51100",{"type":46,"coordinates":114},[115,116],4.02853,49.26526,{"lat":116,"lon":115},[119,123],{"name":120,"role":34,"phone":121,"phoneExt":26,"email":122},"Stéphane GENNAI, MD","0326832565","sgennai@chu-reims.fr",{"name":120,"role":57,"phone":26,"phoneExt":26,"email":26},{"type":125,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100644961","interest-of-the-negative-predictive-value-of-integrons-in-the-reduction-of-large-broad-spectrum-antibiotics-consumption-for-urinary-tract-infections-100644961",false,"NCT07675018","INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS","INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS: a Randomized Trial","INVICTUS","Inclusion Criteria:\n\n* Age ≥ 18 years old; Hospitalized or admitted to the Emergency department;\n* Diagnosis of non-severe (qSOFA \\\u003C 2) urinary tract infection coupled with fever ≥ 38°C or \\\u003C 36°C\n* Presence of bacteria in the fresh urine sample and\u002For GNB on the Gram stain\n* Empirical parenteral antibiotic therapy required; Hospitalization required;\n* Former documentation of a 3GC-resistant GNB on a microbiological sample in the previous six months\n* Informed consent of the patient or their representative\n\nExclusion Criteria:\n\n* Pregnant and\u002For breastfeeding\n* Neutropenia (absolute neutrophil count \\\u003C 500 \u002F mm3)\n* Severe UTI with sepsis (qSOFA ≥ 2) or septic shock\n* Urinary derivation required (ureteral catheter\u002Fper-cutaneous nephrostomy) except for simple urinary catheterization\n* Known allergy to β-lactams\n* Patients with a former documentation with carbapenemase-producing Enterobacterales in the last 6 months\n* Ongoing antibiotic treatment with 3GC, piperacillin-tazobactam or carbapenem\n* Not affiliated to Social Security","ALL","18 Years",{"count":137,"type":138},204,"ESTIMATED","INTERVENTIONAL",[141],"NA","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\\\u003C2) 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.",[144,145,146,147],"Drug Resistance, Microbial","Biomarkers","Urinary Tract Infections (UTI's)","Antibacterial Agents",[149,150,151,152],"Integron","Antimicrobial Stewardship","Antimicrobial Resistance","Urinary Tract Infections","NOT_YET_RECRUITING","2026-06-29",{"date":156,"type":157},"2026-07-01","ACTUAL",{"date":159,"type":138},"2026-09-15",{"date":161,"type":138},"2028-09-21",{"name":5,"class":6},7]