protocolSection identificationModule nctId: NCT06387147, orgStudyIdInfo id: APHP220818, briefTitle: ORal Antibiotics In Acute Mesenteric Ischemia, acronym: ORIAMI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-10-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Acute mesenteric ischemia (AMI) is a life-threatening condition with an increasing incidence (7-13/100000 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 24/7 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., conditionsModule conditions: Acute Mesenteric Ischemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double-blind Gentamicin + Metronidazole versus placebo, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 196, type: ESTIMATED, armsInterventionsModule interventions name: Gentamicin, interventions name: Placebo, interventions name: Metronidazole, outcomesModule primaryOutcomes measure: 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., secondaryOutcomes measure: the rate of intestinal necrosis in the 30 days following the randomisation, secondaryOutcomes measure: the rate of short bowel syndrome (<200cm of remnant small bowel) at day-30 following the randomisation, secondaryOutcomes measure: the length of intestinal resection at day-30 following the randomisation, secondaryOutcomes measure: the occurrence of organ failures within the 30 days following the randomisation, secondaryOutcomes measure: the length of ICU stay, secondaryOutcomes measure: the length of hospital stay, secondaryOutcomes measure: expected minor side effects during the 14 days of treatment, secondaryOutcomes measure: hypersensitivity reactions during the 14 days of treatment, secondaryOutcomes measure: unexpected or serious adverse event throughout the duration of the study, secondaryOutcomes measure: the occurrence of healthcare-associated infection, secondaryOutcomes measure: the gentamicin during the 14 days of treatment, secondaryOutcomes measure: the metronidazole during the 14 days of treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gastroentérologie-Hépatologie Beaujon, city: Clichy, zip: 92110, country: France, contacts name: Alexandre NUZZO, Dr, role: CONTACT, phone: (0)1 40 87 56 57, email: alexandre.nuzzo@aphp.fr, geoPoint lat: 48.90018, lon: 2.30952, locations facility: Réanimation - Beaujon, city: Clichy, zip: 92110, country: France, contacts name: Emmanuel WEISS, Dr, role: CONTACT, email: emmanuel.weiss@aphp.fr, geoPoint lat: 48.90018, lon: 2.30952, locations facility: Chirurgie vasculaire, city: Paris, zip: 75018, country: France, contacts name: Yves Hervé CASTIER, role: CONTACT, email: yves.castier@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Réanimation Bichat, city: Paris, zip: 75018, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False