Oral antibiotics for treating acute mesenteric ischemia
Official title: ORal Antibiotics in Acute Mesenteric Ischemia: a Multicenter Randomized Controlled Trial
Run by Assistance Publique - Hôpitaux de Paris · NCT06387147 · Data updated 2026-11-12
This study is testing if giving oral antibiotics to patients with acute mesenteric ischemia can help them survive better and avoid surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 196 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 4 sites (Clichy, France and 3 other locations) |
| Status | Recruiting |
| Started | January 31, 2025 |
| Main results expected | November 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | February 19, 2025 |
| Trial ID | NCT06387147 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 90 diagnosed with acute mesenteric ischemia of arterial occlusive origin.
✕Probably not a fit
Patients with other forms of mesenteric ischemia or those not eligible for intensive care or surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of oral antibiotics in patients with acute mesenteric ischemia (AMI), a serious condition that can lead to intestinal necrosis. Eligible participants will be randomly assigned to receive either gentamicin and metronidazole or a placebo, with evaluations conducted at multiple time points post-randomization. The study aims to determine if early antibiotic intervention can improve survival rates and reduce the need for surgical resection. Conducted at the SURVI unit in Beaujon Hospital, this trial represents a novel approach to managing AMI.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and reduce complications for patients with acute mesenteric ischemia.
How similar studies have gone: While this approach is novel, preliminary pilot studies have shown promising results in improving survival and reducing surgical interventions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient aged 18 and less 90 * AMI of arterial occlusive origin, defined by the combination of 1. Onset \< 7 days of clinical, biological and/or radiological signs of acute intestinal injury in the territory of at least superior mesenteric ischemia, including right-side colitis, 2. significant vascular obstruction \> 75% of the superior mesenteric artery, and 3. no alternative diagnosis * Admitted to the SURVI care network (Beaujon Hospital intensive care unit or SURVI, Bichat intensive care unit or vascular surgery department) Exclusion Criteria: * Other forms of mesenteric ischemia (chronic without acute manifestations, venous, non-occlusive, strangulation, aortic dissection) * Isolated left-side ischemic colitis * Mesenteric vascular lesion without small bowel injury or right colon * Not eligible for vascular or digestive surgery or intensive care (palliative context) * Indication for an emergency surgical intestinal resection at the admission to the SURVI care network * Indication for urgent systemic antibiotic treatment on admission (evidence of sepsis defined as a SOFA score of 2 or more associated with an infection) * Systemic or oral antibiotic therapy within 7 days before inclusion * Known hypersensitivity to the active substance /excipients * Contraindications to the investigational medicinal products (gentamicin, metronidazole) * Unable to give consent (under guardianship or curatorship) * Subject deprived of freedom, subject under a legal protective measure * Patient refusal to participate * Non-affiliation to a social security regimen or CMU * Patient under State Medical Aid * Pregnant or breastfeeding women * Participation in another clinical study involving investigational medicinal product or patient being in the exclusion period at the end of a previous study
Where it's running
-
Gastroentérologie-Hépatologie Beaujon
Clichy, France, France Recruiting -
Réanimation - Beaujon
Clichy, France, France Recruiting -
Chirurgie vasculaire
Paris, France, France Not yet recruiting -
Réanimation Bichat
Paris, France, France Not yet recruiting
Study contacts
- Study coordinator: Alexandre NUZZO, Dr
- Email: alexandre.nuzzo@aphp.fr
- Phone: (0)1 40 87 56 57
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.