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New treatment option for Acute Mesenteric Ischemia
Official title ORal Antibiotics in Acute Mesenteric Ischemia
ClinicalTrials.gov ID: NCT06387147
What this study is testing
What is Gentamicin?
Gentamicin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute mesenteric ischemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- significant vascular obstruction \> 75% of the superior mesenteric artery, and
- no alternative diagnosis
You likely can't join if
- 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...
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Clichy, France, France
- Paris, France, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy, France, France; Paris, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.