[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"enterobacteriaceae-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:enterobacteriaceae-infections":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,77,109,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100644853","genomic-and-phenotypic-diversity-of-carbapenemase-producing-escherichia-coli-strains-circulating-in-southern-france-100644853",false,"NCT07676513","Genomic and Phenotypic Diversity of Carbapenemase-producing Escherichia Coli Strains Circulating in Southern France.","Genomic and Phenotypic Diversity of Carbapenemase-producing Escherichia Coli Strains Circulating in Southern France. The \"CARBA-COLI\" Study","CARBACOLI","Inclusion Criteria:\n\n* Not applicable to this study of an existing collection of Carbapenemase-producing Enterobacteriaceae strains.\n\nExclusion Criteria:\n\n* Not applicable to this study of an existing collection of Carbapenemase-producing Enterobacteriaceae strains.","ALL",{"count":19,"type":20},163,"ESTIMATED","3 Years","OBSERVATIONAL","Carbapenemase-producing Enterobacteriaceae (CPE) are classified as emerging Highly Resistant Bacteria (eHRB) because they expose infected patients to the risk of treatment failure due to the strains' resistance to last-line β-lactams, carbapenems, and frequent co-resistance to other classes of antibiotics, leading to increased morbidity and mortality. Their high epidemiogenic potential has enabled their global spread. In France, the incidence of Carbapenemase-producing Enterobacteriaceae is rising sharply, both in colonization and in infections. Parallel to this increase, Escherichia coli has become the most common Carbapenemase-producing Enterobacteriaceae (35% of strains in 2024, National Research Committee data), surpassing Klebsiella pneumoniae (24%).\n\nThe investigators hypothesize that the increase in the prevalence of carbapenemase-producing Echerichia coli is associated with a diversification of clones, enzymes, and their variants, and may pose a threefold threat: i) the spread of genes encoding carbapenemases within pathogenic extraintestinal Echerichia coli (ExPEC) pathogroups responsible for urinary tract infections and bacteremias, with a high risk of resistance spreading in the community, ii) the silent spread of Echerichia coli strains producing OXA-48 variants with reduced carbapenem hydrolytic activity, OXA-244 and OXA-484, which are not detected or poorly detected by conventionally used screening media and iii) the emergence of New Dehli Metallo-beta-lactamase (NDM) variants with high hydrolytic activity, such as NDM-5, within Echerichia coli clones possessing Penicillin-Binding Proteins (PLPs) with low affinity for antibiotics, leading to very high-level resistance and a therapeutic dead end in infected patients.",[25,26,27,28],"Antibiotic Resistance","Enterobacteriaceae Infections","Carbapenem-Resistant Enterobacteriaceae Infection","Colonization",[30,27,28,26],"Escherichia coli","NOT_YET_RECRUITING","2026-06-24",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":20},"2026-06-01",{"date":39,"type":20},"2028-06-01",{"name":41,"class":42},"Centre Hospitalier Universitaire de Nīmes","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":43},"100420764","phase-1-fmt-for-the-decolonization-of-carbapenem-resistant-enterobacteriaceae-100420764","NCT04759001","FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae","Faecal Microbiota Transplantation to Eradicate Gut Colonisation From Carbapenem-resistant Enterobacteriaceae: a Randomised Controlled Trial","FMT-CRE","Inclusion criteria\n\n* 18 years old or older\n* Current evidence of gut colonisation (diagnosed with rectal swab) by CRE\n* Ability to give their consent to be included in the study.\n\nExclusion criteria\n\n* Another known gastrointestinal infection apart from C. difficile infection\n* Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea)\n* Previous colorectal surgery or cutaneous stoma\n* Food allergies\n* Current or recent (\\\u003C2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin)\n* Decompensated heart failure or heart disease with ejection fraction lower than 30%\n* Severe respiratory insufficiency\n* Psychiatric disorders\n* Pregnancy\n* Unable to give informed consent","18 Years","90 Years",{"count":55,"type":20},52,"INTERVENTIONAL",[58,59],"PHASE1","PHASE2","Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes. Healthy gut microbiota is known to prevent the colonization of the gastrointestinal tract by pathogens, the so-called mechanism of colonization resistance, but this protective mechanism can be altered by therapies that impair gut microbiota, including antibiotics or chemotherapeutics, with consequent colonisation of gut pathogens, including multi-drug resistant bacteria (MDRB). MDRB carriers represent an epidemiological threat to other hospitalized patients and to the whole community, but are also at risk of developing clinical consequences of this colonization, including bloodstream infections from these pathogens. Fecal microbiota transplantation (FMT) has shown high efficacy in the eradication of recurrent C. difficile infection, and initial evidence suggests that this procedure could be useful in eradicating also MDRB, mainly carbapenem-resistant Enterobacteriaceae.\n\nHowever, current evidence is mostly limited to case reports and case series, and to a single randomised trial, which was stopped early and did not draw clear conclusion. In a systematic review of 21 studies and 192 patients, eradication rates ranged from 0% to 100%, and authors concluded that larger, well designed randomised controlled trials are needed to further explore this therapy.\n\nThe aim of this study is to investigate the efficacy of FMT, compared with placebo FMT, in eradicating gut colonisation from MDRB, focusing on CRE. The investigators will randomize patients colonized by CRE (diagnosed by rectal swab) to FMT from healthy donors or placebo, by colonoscopy. Then, patients will be followed up, rectal swabs will be repeated, and stool samples for culture and microbiome analysis will be collected, up to 3 months after FMT.",[26,62],"Multi-antibiotic Resistance",[64,65,66],"Fecal microbiota transplantation","Enterobacteriaceae","Multi-drug resistant bacteria","RECRUITING","2026-03-17",{"date":70,"type":35},"2026-03-19",{"date":72,"type":35},"2021-02-18",{"date":74,"type":20},"2026-08-15",{"name":76,"class":42},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":56,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100337324","phase-4-piperacillin-tazobactam-versus-meropenem-for-treatment-of-bloodstream-infections-caused-by-cephalosporin-resistant-enterobacteriaceae-peterpen-100337324","NCT03671967","PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)","Piperacillin Tazobactam Versus Meropenem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae- a Non-inferiority Randomized Controlled Trial","PETERPEN","Inclusion Criteria:\n\n1. Adults (age ≥ 18 years)\n2. New onset BSI due to E. coli or Klebsiella spp. in one or more blood cultures associated with evidence of infection.\n3. The microorganism will have to be non-susceptible to third generation cephalosporins (ceftriaxone and ceftazidime) and susceptible to both PTZ and meropenem (see microbiological methods).\n4. Both community and hospital-acquired bacteremias will be included.\n5. We will permit the inclusion of bacteremias due to E. coli or Klebsiella spp. with concomitant growth in blood of skin commensals considered as contaminants.\n\nExclusion Criteria:\n\n1. More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.).\n2. Polymicrobial bacteremia. Polymicrobial bacteremia will be defined as either growth of two or more different species of microorganisms in the same blood culture, or growth of different species in two or more separate blood cultures within the same episode.\n3. Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode.\n4. Patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure \\\u003C 90 mmHg and\u002For use of vasopressors (dopamine\\>15μg\u002Fkg\u002Fmin, adrenalin\\>0.1μg\u002Fkg\u002Fmin, noradrenalin\\>0.1μg\u002Fkg\u002Fmin, vasopressin any dose) in the 12 hours prior to randomization. In the absence of the use of vasopressors, a systolic blood pressure \\\u003C90 would need to represent a deviation for the patient's known normal blood pressure.\n5. BSI due to specific infections known at the time of randomization:\n\n   1. Endocarditis \u002F endovascular infections\n   2. Osteomyelitis (not resected)\n   3. Central nervous system infections\n6. Allergy to any of the study drugs confirmed by history taken by the investigator\n7. Previous enrollment in this trial\n8. Concurrent participation in another interventional clinical trial\n9. Imminent death (researcher's assessment of expected death within 48 hrs. of recruitment)",{"count":86,"type":20},1084,[88],"PHASE4","Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae blood-stream infection are lacking. Observational studies show conflicting results when comparing treatment with combination beta-lactam-beta-lactamase inhibitor and carbapenems. The investigators aim to evaluate the effect of definitive treatment with meropenem vs. piperacillin-tazobactam on the outcome of patients with bacteremia due to cephalosporin-non-susceptible Enterobacteriaceae. The investigators hypothesize that piperacillin-tazobactam is non-inferior to meropenem.",[91,26,92],"Beta Lactam Resistant Bacterial Infection","Bacteremia",[94,95,96,97,98],"bacteremia","enterobacteriaceae","extended spectrum beta-lactamase","meropenem","piperacillin tazobactam","2025-07-29",{"date":101,"type":35},"2025-08-01",{"date":103,"type":35},"2019-05-01",{"date":105,"type":20},"2027-04-01",{"name":107,"class":42},"Rambam Health Care Campus",14,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":56,"phases":119,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100441973","phase-3-fecal-transplantation-to-eradicate-colonizing-emergent-superbugs-100441973","NCT05035342","Fecal Transplantation to Eradicate Colonizing Emergent Superbugs","FECES","Inclusion Criteria:\n\nInclusion Criteria for patients:\n\n* ≥ 18 years and \\\u003C 105 years\n* Patient with at least one positive rectal swab for enterobacteria:\n\nextended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) or carbapenem-resistant Enterobacteriaceae (CRE), or who have had an ESBL-E or CRE infection within the year For ESBL-E carriers: an ESBL-E infection within the year is mandatory\n\n\\- Patient able to take 50 capsules orally in a day and without swallowing disorders\n\nInclusion Criteria for healthy volunteers donors:\n\n* Healthy subjects ≥ 18 years and \\\u003C 50 years\n* Body mass index \\\u003C 30 kg\u002Fm\\^2\n* Regular bowel movement defined as at least 1 stool every 2 daysand maximum than 3 stools per day\n\nExclusion Criteria:\n\nExclusion Criteria for patients:\n\n* Current antibiotic treatment with te exception of long term antibiotic prophylaxis (duration of at least 3 months\u002Fyear)\n* Patients hospitalized in the intensive care unit\n* Pregnancy or breastfeeding during the study\n* Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control \\[such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)\\] to avoid pregnancy for the entire study\n* Patient under legal protection\n* Participation in another interventional study\n* Non-affiliation to a social security scheme\n* Patient under AME\n* Refusal to participate to the study\n\nExclusion Criteria for healthy volunteers donors:\n\n* Any history of or current proctologic disease or any acute condition, which in the investigator's judgment could harm the volunteer and\u002For compromise or limit the evaluation of the protocol or data analysis (for details, please see protocol)\n* Subject under legal protection\n* Participation in any other interventional study\n* No-affiliation to a social security scheme\n* Subject under AME\n* Refusal to participate to the study\n\nRandomization criteria:\n\n* Patient colonized with a carbapenem-resistant Enterobacteriaceae (CRE) and\u002For colonized with an extended spectrum β-lactamase producing Enterobacteriaceae (ESBL-E) at inclusion on stool culture\n* Patient with an ESBL-E infection in the previous 12 months (only for participants no colonized with CRE).\n* Compatible transplant (FMT) based on patient's serological profile (CMV\u002FEBV) available","105 Years",{"count":118,"type":20},214,[120],"PHASE3","Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization.",[26,123],"Fecal Microbiota Transplantation","2025-05-21",{"date":126,"type":35},"2025-05-25",{"date":128,"type":35},"2024-01-11",{"date":130,"type":20},"2028-04",{"name":132,"class":42},"Assistance Publique - Hôpitaux de Paris",11,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":56,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":43},"100500064","phase-1-fmt-to-eradicate-intestinal-colonization-by-carbapenem-resistant-enterobacteriaceae-100500064","NCT05791396","FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae","Efficacy and Mechanisms of Fecal Microbiota Transplantation to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae","FMT_CRE","Inclusion Criteria:\n\n* \\>18 years;\n* CRE diagnosed with rectal swab \\\u003C15 days before evaluation;\n* Ability to undergo study procedures and to give informed consent.\n\nExclusion Criteria:\n\n* Active chronic gastrointestinal disorders;\n* Previous colorectal surgery;\n* Major comorbidities;\n* Pregnancy\u002Fbreastfeeding;\n* Psychiatric disorders.","85 Years",{"count":144,"type":20},36,[58,59],"Antibiotic resistance (AR) is a critical public health threat and one of the greatest challenges of the 21st century. In an estimate of 2019, nearly 700.000 infections and 33.000 attributable deaths from multi-drug-resistant bacteria (MDRB) have occurred in Europe in 2015. The gastrointestinal tract is a large reservoir for MDRB, and the gut microbiota can harbor a collection of AR genes, called gut resistome. Preliminary nonrandomized evidence suggests that fecal microbiota transplant (FMT) could be a promising treatment option to eradicate MDRB, but established evidence, as well as mechanisms that underpin this therapeutic pathway, are still unavailable. Leveraging our expertise in FMT (OU1), microbiome (OU2) and MDRB (OU3), we aim to evaluate the efficacy of FMT (from donors with limited presence of AR genes) in eradicating intestinal MDRB through a randomized controlled trial and identifying microbial features that are associated with clinical efficacy and clearance of AR genes",[26,62],[64,65,66],"2025-03-10",{"date":151,"type":35},"2025-03-12",{"date":153,"type":35},"2024-02-08",{"date":155,"type":20},"2026-04",{"name":76,"class":42}]