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NCT Number: NCT06387147

ORal Antibiotics in Acute Mesenteric Ischemia

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.

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Key information

Conditions

Acute Mesenteric Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gastroentérologie-Hépatologie Beaujon, Clichy, France

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About this study

After the screening visit and informed consent collected by the recruiting investigator, all consecutive eligible patients (who will meet all inclusion criteria and none of exclusion criteria) will be included and randomized double-blind to oral antibiotics or double placebo group.

Patients will be evaluated at days 1, 3, 7, 14, 21 and 30 after the randomisation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient aged 18 and less 90
  • AMI of arterial occlusive origin, defined by the combination of
  • 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,
  • significant vascular obstruction > 75% of the superior mesenteric artery, and
  • 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

Treatment and study plan

Gentamicin

Drug

Gentamicin 80 mg 3 times per day during 14 days oral route or nasogastric tube or jejunostomy tube (in the case of an ostomy)

Placebo

Drug

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

Metronidazole

Drug

Métronidazole 500mg 3 times per day during 14 days oral route or nasogastric tube or jejunostomy tube (in the case of an ostomy)

Primary outcomes

  1. 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.

    Time frame: 30 days after randomisation

    Occurrence of intestinal necrosis or death within 30 days following randomisation defined by the following criteria histology assessment OR all-cause mortality within 30 days following randomisation

Secondary outcomes

  1. the rate of intestinal necrosis in the 30 days following the randomisation

    Time frame: 30 days after randomisation

    occurrence of intestinal necrosis within the 30 days following the randomisation.

  2. the rate of short bowel syndrome (<200cm of remnant small bowel) at day-30 following the randomisation

    Time frame: 30 days after randomisation

    short bowel syndrome at day-30 after the randomisation

  3. the length of intestinal resection at day-30 following the randomisation

    Time frame: 30 days after randomisation

    total length of intestinal resection at day 30 following the randomisation

  4. the occurrence of organ failures within the 30 days following the randomisation

    Time frame: 30 days after randomisation

    occurrence of organ failure within the 30 days following the randomisation

  5. the length of ICU stay

    Time frame: 30 days after randomisation

    number of days in the intensive care unit

  6. the length of hospital stay

    Time frame: 30 days after randomisation

    number of hospitalization days

  7. expected minor side effects during the 14 days of treatment

    Time frame: 14 days after randomisation

    Occurrence of minor side effects

  8. hypersensitivity reactions during the 14 days of treatment

    Time frame: 14 days after randomisation

    Occurrence of hypersensitivity reaction to antibiotics

  9. unexpected or serious adverse event throughout the duration of the study

    Time frame: 30 days after randomisation

    Occurrence of other adverse events

  10. the occurrence of healthcare-associated infection

    Time frame: 30 days after randomisation

    Occurrence of healthcare-associated infection

  11. the gentamicin during the 14 days of treatment

    Time frame: 14 days after randomisation

    Blood levels of gentamicin at randomisation day , days 7 and 14 after randomisation

  12. the metronidazole during the 14 days of treatment

    Time frame: 14 days after randomisation

    Blood levels of metronidazole at randomisation day, days 7 and 14 after randomisation

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre NUZZO, Dr

CONTACT

[email protected]

(0)1 40 87 56 57

Olivier CORCOS, Pr

CONTACT

[email protected]

(0)1 40 87 56 95

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: ORIAMI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 26, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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