Recruiting

ORIAMIORal Antibiotics in Acute Mesenteric Ischemia: a Multicenter Randomized Controlled Trial

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What is being tested

Gentamicin

+ Metronidazole

+ Placebo

Drug
Who is being recruted

Necrosis

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

From 18 to 90 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactAlexandre NUZZO, DrMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 31, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating the use of oral antibiotics in treating acute mesenteric ischemia, which is a condition where there is a sudden reduction of blood flow to the intestines. This trial is important because it explores whether oral antibiotics can effectively help patients with this serious condition, potentially improving recovery and outcomes. The study aims to provide more clarity on treatment options for patients dealing with this intestinal blood flow issue, which is critical for enhancing patient care and treatment strategies. Participants in the study are randomly assigned to one of two groups: one receiving oral antibiotics and the other receiving a placebo, which is a harmless pill with no active medicine. This is done in a double-blind manner, meaning neither the participants nor the researchers know who is receiving the actual medication, to ensure unbiased results. The health and recovery of the participants are closely monitored through evaluations at various intervals—specifically, on days 1, 3, 7, 14, 21, and 30 after they start the treatment. This careful observation helps researchers gather accurate data on the effectiveness of the antibiotics in treating the condition.

Official TitleORal Antibiotics in Acute Mesenteric Ischemia: a Multicenter Randomized Controlled Trial
NCT06387147
Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactAlexandre NUZZO, DrMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

196 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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)

Group II

Placebo
Gentamicin placebo (2ml sodium chloride diluted 1/10 in a syringe of 20mL Metronidazole placebo in tablets

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Gastroentérologie-Hépatologie Beaujon

Clichy, FranceOpen Gastroentérologie-Hépatologie Beaujon in Google Maps
Recruiting

Réanimation - Beaujon

Clichy, France
Recruiting soon

Chirurgie vasculaire

Paris, France
Recruiting soon

Réanimation Bichat

Paris, France
Recruiting
4 Study Centers