A Phase 3 interventional study of Gentamicin and Placebo in Acute Mesenteric Ischemia, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 4 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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.
90 studies on the registry are indexed under Necrosis; 23 are open to participants now.
This study's planned enrollment of 196 is above the median of 50 across 53 interventional studies indexed under Necrosis.
Browse Necrosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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AMI of arterial occlusive origin, defined by the combination of
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Gentamicin · Drug: Metronidazole
Gentamicin placebo (2ml sodium chloride diluted 1/10 in a syringe of 20mL Metronidazole placebo in tablets
Drug: Placebo
Gentamicin 80 mg 3 times per day during 14 days oral route or nasogastric tube or jejunostomy tube (in the case of an ostomy)
Gentamicin placebo (2ml sodium chloride diluted 1/10 in a syringe of 20mL Metronidazole placebo in tablets
Métronidazole 500mg 3 times per day during 14 days oral route or nasogastric tube or jejunostomy tube (in the case of an ostomy)
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.
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
Time frame: 30 days after randomisation
the rate of intestinal necrosis in the 30 days following the randomisation
occurrence of intestinal necrosis within the 30 days following the randomisation.
Time frame: 30 days after randomisation
the rate of short bowel syndrome (<200cm of remnant small bowel) at day-30 following the randomisation
short bowel syndrome at day-30 after the randomisation
Time frame: 30 days after randomisation
the length of intestinal resection at day-30 following the randomisation
total length of intestinal resection at day 30 following the randomisation
Time frame: 30 days after randomisation
the occurrence of organ failures within the 30 days following the randomisation
occurrence of organ failure within the 30 days following the randomisation
Time frame: 30 days after randomisation
the length of ICU stay
number of days in the intensive care unit
Time frame: 30 days after randomisation
the length of hospital stay
number of hospitalization days
Time frame: 30 days after randomisation
expected minor side effects during the 14 days of treatment
Occurrence of minor side effects
Time frame: 14 days after randomisation
hypersensitivity reactions during the 14 days of treatment
Occurrence of hypersensitivity reaction to antibiotics
Time frame: 14 days after randomisation
unexpected or serious adverse event throughout the duration of the study
Occurrence of other adverse events
Time frame: 30 days after randomisation
the occurrence of healthcare-associated infection
Occurrence of healthcare-associated infection
Time frame: 30 days after randomisation
the gentamicin during the 14 days of treatment
Blood levels of gentamicin at randomisation day , days 7 and 14 after randomisation
Time frame: 14 days after randomisation
the metronidazole during the 14 days of treatment
Blood levels of metronidazole at randomisation day, days 7 and 14 after randomisation
Time frame: 14 days after randomisation
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Nov 2027, 33 months after the start.
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Studies of the drugs tested here: Gentamicins · Metronidazole
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