Actively Recruiting

Phase 3
Age: 18Years - 90Years
All Genders
NCT06387147

ORal Antibiotics in Acute Mesenteric Ischemia

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-02-19

196

Participants Needed

4

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

ORal Antibiotics in Acute Mesenteric Ischemia

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient aged 18 to less than 90 years
  • Acute mesenteric ischemia of arterial occlusive origin diagnosed by clinical, biological, and/or radiological signs within 7 days
  • Significant vascular obstruction greater than 75% of the superior mesenteric artery
  • No alternative diagnosis for the intestinal injury
  • Admission to the SURVI care network at specified hospitals
Not Eligible

You will not qualify if you...

  • Other types of mesenteric ischemia such as chronic, venous, non-occlusive, strangulation, or aortic dissection
  • Isolated left-side ischemic colitis
  • Mesenteric vascular lesion without small bowel or right colon injury
  • Not eligible for vascular or digestive surgery or intensive care (palliative context)
  • Urgent need for surgical intestinal resection at admission
  • Need for immediate systemic antibiotic treatment due to sepsis (SOFA score 2 or more with infection)
  • Systemic or oral antibiotic therapy within 7 days before inclusion
  • Known allergy to study drugs or their components
  • Contraindications to gentamicin or metronidazole
  • Unable to provide consent due to guardianship or curatorship
  • Subject under legal protective measures or deprived of freedom
  • Refusal to participate
  • Not affiliated with social security or CMU
  • Patient under State Medical Aid
  • Pregnant or breastfeeding women
  • Participation in another clinical trial involving investigational drugs or still in exclusion period after previous study

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Gastroentérologie-Hépatologie Beaujon

Clichy, France, France, 92110

Actively Recruiting

2

Réanimation - Beaujon

Clichy, France, France, 92110

Actively Recruiting

3

Chirurgie vasculaire

Paris, France, France, 75018

Not Yet Recruiting

4

Réanimation Bichat

Paris, France, France, 75018

Not Yet Recruiting

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Research Team

A

Alexandre NUZZO, Dr

CONTACT

O

Olivier CORCOS, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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ORal Antibiotics in Acute Mesenteric Ischemia | DecenTrialz