[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545840":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":64,"studyPopulation":51,"armGroups":65,"interventions":79,"overallOfficials":91,"centralContacts":96,"locations":106,"responsibleParty":154,"collaborators":51,"id":156,"slug":51,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":157,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":51,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":109,"whyStopped":51,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"The primary objective is to assess the efficacy of oral antibiotics compared to placebo on reducing the rate of intestinal necrosis or death (composite primary outcome) in AMI patients within 30 days following the randomisation.","Occurrence of intestinal necrosis or death within 30 days following randomisation defined by the following criteria histology assessment OR all-cause mortality within 30 days following randomisation","30 days after randomisation",[14,17,20,23,26,29,32,36,39,42,45,48],{"measure":15,"description":16,"timeFrame":12},"the rate of intestinal necrosis in the 30 days following the randomisation","occurrence of intestinal necrosis within the 30 days following the randomisation.",{"measure":18,"description":19,"timeFrame":12},"the rate of short bowel syndrome (\u003C200cm of remnant small bowel) at day-30 following the randomisation","short bowel syndrome at day-30 after the randomisation",{"measure":21,"description":22,"timeFrame":12},"the length of intestinal resection at day-30 following the randomisation","total length of intestinal resection at day 30 following the randomisation",{"measure":24,"description":25,"timeFrame":12},"the occurrence of organ failures within the 30 days following the randomisation","occurrence of organ failure within the 30 days following the randomisation",{"measure":27,"description":28,"timeFrame":12},"the length of ICU stay","number of days in the intensive care unit",{"measure":30,"description":31,"timeFrame":12},"the length of hospital stay","number of hospitalization days",{"measure":33,"description":34,"timeFrame":35},"expected minor side effects during the 14 days of treatment","Occurrence of minor side effects","14 days after randomisation",{"measure":37,"description":38,"timeFrame":35},"hypersensitivity reactions during the 14 days of treatment","Occurrence of hypersensitivity reaction to antibiotics",{"measure":40,"description":41,"timeFrame":12},"unexpected or serious adverse event throughout the duration of the study","Occurrence of other adverse events",{"measure":43,"description":44,"timeFrame":12},"the occurrence of healthcare-associated infection","Occurrence of healthcare-associated infection",{"measure":46,"description":47,"timeFrame":35},"the gentamicin during the 14 days of treatment","Blood levels of gentamicin at randomisation day , days 7 and 14 after randomisation",{"measure":49,"description":50,"timeFrame":35},"the metronidazole during the 14 days of treatment","Blood levels of metronidazole at randomisation day, days 7 and 14 after randomisation",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":51,"timePerspective":51,"maskingInfo":57},"RANDOMIZED","PARALLEL","double-blind Gentamicin + Metronidazole versus placebo","TREATMENT",{"masking":58,"maskingDescription":51,"whoMasked":59},"QUADRUPLE",[60,61,62,63],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","After the screening visit and informed consent collected by the recruiting investigator, all consecutive eligible patients (who will meet all inclusion criteria and none of exclusion criteria) will be included and randomized double-blind to oral antibiotics or double placebo group.\n\nPatients will be evaluated at days 1, 3, 7, 14, 21 and 30 after the randomisation.",[66,73],{"label":67,"type":68,"description":69,"interventionNames":70},"Gentamicin + Metronidazole","EXPERIMENTAL","Gentamicin 80 mg Metronidazole 500mg 3 times per day during 14 days oral route or nasogastric tube or jejunostomy tube (in the case of an ostomy)",[71,72],"Drug: Gentamicin","Drug: Metronidazole",{"label":74,"type":75,"description":76,"interventionNames":77},"Placebo","PLACEBO_COMPARATOR","Gentamicin placebo (2ml sodium chloride diluted 1\u002F10 in a syringe of 20mL Metronidazole placebo in tablets",[78],"Drug: Placebo",[80,85,87],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":51},"DRUG","Gentamicin","Gentamicin 80 mg 3 times per day during 14 days oral route or nasogastric tube or jejunostomy tube (in the case of an ostomy)",[67],{"type":81,"name":74,"description":76,"armGroupLabels":86,"otherNames":51},[74],{"type":81,"name":88,"description":89,"armGroupLabels":90,"otherNames":51},"Metronidazole","Métronidazole 500mg 3 times per day during 14 days oral route or nasogastric tube or jejunostomy tube (in the case of an ostomy)",[67],[92],{"name":93,"affiliation":94,"role":95},"Annabelle METOIS, Mrs","APHP","STUDY_CHAIR",[97,102],{"name":98,"role":99,"phone":100,"phoneExt":51,"email":101},"Alexandre NUZZO, Dr","CONTACT","(0)1 40 87 56 57","alexandre.nuzzo@aphp.fr",{"name":103,"role":99,"phone":104,"phoneExt":51,"email":105},"Olivier CORCOS, Pr","(0)1 40 87 56 95","olivier.corcos@aphp.fr",[107,122,131,145],{"facility":108,"status":109,"city":110,"state":111,"zip":112,"country":111,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"Gastroentérologie-Hépatologie Beaujon","RECRUITING","Clichy","France","92110","FR",{"type":115,"coordinates":116},"Point",[117,118],2.30952,48.90018,{"lat":118,"lon":117},[121],{"name":98,"role":99,"phone":100,"phoneExt":51,"email":101},{"facility":123,"status":109,"city":110,"state":111,"zip":112,"country":111,"countryCode":113,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Réanimation - Beaujon",{"type":115,"coordinates":125},[117,118],{"lat":118,"lon":117},[128],{"name":129,"role":99,"phone":51,"phoneExt":51,"email":130},"Emmanuel WEISS, Dr","emmanuel.weiss@aphp.fr",{"facility":132,"status":133,"city":134,"state":111,"zip":135,"country":111,"countryCode":113,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Chirurgie vasculaire","NOT_YET_RECRUITING","Paris","75018",{"type":115,"coordinates":137},[138,139],2.3488,48.85341,{"lat":139,"lon":138},[142],{"name":143,"role":99,"phone":51,"phoneExt":51,"email":144},"Yves Hervé CASTIER","yves.castier@aphp.fr",{"facility":146,"status":133,"city":134,"state":111,"zip":135,"country":111,"countryCode":113,"cosmosGeoPoint":147,"geoPoint":149,"contacts":150},"Réanimation Bichat",{"type":115,"coordinates":148},[138,139],{"lat":139,"lon":138},[151],{"name":152,"role":99,"phone":51,"phoneExt":51,"email":153},"Brice LORTAT JACOB, Dr","brice.lortat-jacob@aphp.fr",{"type":155,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100545840",false,"NCT06387147","ORal Antibiotics in Acute Mesenteric Ischemia","ORal Antibiotics in Acute Mesenteric Ischemia: a Multicenter Randomized Controlled Trial","ORIAMI","Inclusion Criteria:\n\n* Adult patient aged 18 and less 90\n* AMI of arterial occlusive origin, defined by the combination of\n\n  1. Onset \\\u003C 7 days of clinical, biological and\u002For radiological signs of acute intestinal injury in the territory of at least superior mesenteric ischemia, including right-side colitis,\n  2. significant vascular obstruction \\> 75% of the superior mesenteric artery, and\n  3. no alternative diagnosis\n* Admitted to the SURVI care network (Beaujon Hospital intensive care unit or SURVI, Bichat intensive care unit or vascular surgery department)\n\nExclusion Criteria:\n\n* Other forms of mesenteric ischemia (chronic without acute manifestations, venous, non-occlusive, strangulation, aortic dissection)\n* Isolated left-side ischemic colitis\n* Mesenteric vascular lesion without small bowel injury or right colon\n* Not eligible for vascular or digestive surgery or intensive care (palliative context)\n* Indication for an emergency surgical intestinal resection at the admission to the SURVI care network\n* Indication for urgent systemic antibiotic treatment on admission (evidence of sepsis defined as a SOFA score of 2 or more associated with an infection)\n* Systemic or oral antibiotic therapy within 7 days before inclusion\n* Known hypersensitivity to the active substance \u002Fexcipients\n* Contraindications to the investigational medicinal products (gentamicin, metronidazole)\n* Unable to give consent (under guardianship or curatorship)\n* Subject deprived of freedom, subject under a legal protective measure\n* Patient refusal to participate\n* Non-affiliation to a social security regimen or CMU\n* Patient under State Medical Aid\n* Pregnant or breastfeeding women\n* Participation in another clinical study involving investigational medicinal product or patient being in the exclusion period at the end of a previous study","ALL","18 Years","90 Years",{"count":167,"type":168},196,"ESTIMATED","INTERVENTIONAL",[171],"PHASE3","Acute mesenteric ischemia (AMI) is a life-threatening condition with an increasing incidence (7-13\u002F100000 PY). The mortality of AMI is associated with the development and extent of transmural intestinal necrosis (IN), ranging from 25% without IN to 75% with IN. Given its potential reversibility, preventing the progression of AMI towards IN is now considered a primary therapeutic goal. Early management of AMI can thus avoid fatal outcomes and prevent lifelong complications such as short bowel syndrome. Following the results of a pilot study showing an improvement in survival and lower resection rates, our team created a first-of-its-kind intestinal stroke center (SURVI unit, Beaujon Hospital, Clichy, France) that provides 24\u002F7 standardized multimodal and multidisciplinary care to AMI patients referred from all hospitals in the Paris region. As no randomized clinical trial has ever been conducted, the treatment offered by SURVI is based on pathophysiological knowledge and observational clinical data. AMI naturally progresses to sepsis, surgical complications, and multi-organ failure, direct consequences of IN. Features of sepsis are reported in up to 90% of AMI patients compared with 3-22% of patients with brain or myocardial ischemia, supporting a specific septic component in AMI. Experimental studies demonstrated reduced translocation and mortality in germ-free animals or after administration of oral antibiotics targeting Gram-negative and anaerobic early bacterial overgrowth and translocation. In a prospective observational study, the investigators recently suggested a protective effect of systematic oral antibiotics in terms of intestinal preservation, yielding a reduced occurrence of IN (HR: 0.16, 95% confidence interval 0.03-0.62). However, the systematic use of oral antibiotics in AMI remains controversial due to the individual and collective risk of increasing the carriage of multi-drug resistant bacterias.",[174],"Acute Mesenteric Ischemia",[176],"necrosis","2025-02-17",{"date":179,"type":180},"2025-02-19","ACTUAL",{"date":182,"type":180},"2025-01-31",{"date":184,"type":168},"2027-11-01",{"name":5,"class":6},4]