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