BridgeMD
ORIAMI
EU CTIS ID: 2023-508249-42-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Other forms of mesenteric ischemia (chronic without acute manifestations, venous, non-occlusive, strangulation, aortic dissection)
- 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
See the full eligibility 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)
- Other forms of mesenteric ischemia (chronic without acute manifestations, venous, non-occlusive, strangulation, aortic dissection)
- 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.