Study on the Effectiveness of Oral Antibiotics Gentamicin and Metronidazole in Patients with Acute Mesenteric Ischemia

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What is this study about?

This clinical trial is focused on studying the effects of oral antibiotics in patients with acute mesenteric ischemia, a condition where there is a sudden decrease in blood flow to the intestines, which can lead to tissue damage. The study will use two medications: Gentamicin, which is an injectable solution, and Metronidazole, which is a film-coated tablet. Additionally, there will be a placebo group for comparison. The main goal of the study is to determine if these antibiotics can reduce the risk of intestinal tissue death or mortality within 30 days after starting the treatment.

Participants in the study will be randomly assigned to receive either the antibiotics or a placebo. The treatment period will last up to 14 days, and the participants will be monitored for any changes in their condition. The study will track several outcomes, including the occurrence of intestinal necrosis, overall survival, and any side effects from the medications. Blood levels of the antibiotics will also be measured at the start of the study and on days 7 and 14 to understand how the body processes these drugs.

The study aims to provide valuable information on the effectiveness and safety of using oral antibiotics in treating acute mesenteric ischemia. By comparing the outcomes of those receiving the antibiotics to those receiving a placebo, researchers hope to determine the potential benefits of these treatments in managing this serious condition. The study is expected to continue until 2027, with recruitment starting in 2024.

1 randomization

Upon joining the study, the patient is randomly assigned to receive either oral antibiotics or a placebo. This process is known as randomization and ensures that the study results are unbiased.

2 medication administration

The patient receives gentamicin and metronidazole or their respective placebos. Gentamicin is administered as an 80 mg solution for injection, while metronidazole is given as a 500 mg film-coated tablet. Both medications are taken orally, or through a nasogastric or percutaneous endoscopic gastrostomy tube, depending on the patient’s condition.

3 monitoring and assessments

Throughout the trial, the patient’s health is closely monitored. Blood levels of gentamicin and metronidazole are measured on the day of randomization, and again on days 7 and 14. This helps assess the pharmacokinetics, which is how the body absorbs, distributes, metabolizes, and excretes the drugs.

4 evaluation of outcomes

The primary outcome is evaluated by checking for the occurrence of intestinal necrosis or death within 30 days following randomization. Secondary outcomes include the assessment of the patient’s vital status, the occurrence of short bowel syndrome, the total length of intestinal resection, and any organ failure within the same period.

5 safety monitoring

Safety endpoints are monitored, including any minor side effects, hypersensitivity reactions to antibiotics, other adverse events, emergence of antimicrobial-resistant microorganisms, and healthcare-associated infections.

6 completion of trial

The trial is expected to conclude by August 1, 2027. The patient’s participation in the study ends after all necessary data has been collected and analyzed.

Who Can Join the Study?

The patient must be an adult aged between 18 and less than 90 years old.
The patient must have acute mesenteric ischemia of arterial occlusive origin. This means there is a sudden blockage in the blood vessels supplying the intestines, causing injury to the intestines.
The condition must have started less than 7 days ago, with signs of injury to the intestines, which can be seen through symptoms, blood tests, or imaging tests.
There must be a significant blockage, more than 75%, in the superior mesenteric artery, which is a major blood vessel supplying the intestines.
There should be no other diagnosis that explains the symptoms.
The patient must be admitted to the SURVI care network, which includes specific hospitals and departments like the Beaujon Hospital intensive care unit or the Bichat intensive care unit or vascular surgery department.
Both male and female patients are eligible to participate.

Who Cannot Join the Study?

Patients who are not diagnosed with acute mesenteric ischemia cannot participate. This condition involves a sudden decrease in blood flow to the intestines.
Patients who are under 18 years old or over 65 years old are not eligible.
Patients who are part of vulnerable populations, such as those unable to give consent, are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.07.2024

Trial locations

Investigated drugs:

Oral Antibiotics are being tested in this trial to see if they can help reduce the risk of intestinal tissue death or death in patients with acute mesenteric ischemia. These antibiotics are taken by mouth and are being compared to a placebo to determine their effectiveness in improving patient outcomes within 30 days of starting treatment.

Investigated diseases:

Intestinal ischaemia

Acute Mesenteric Ischemia – This condition occurs when there is a sudden reduction of blood flow to the intestines, leading to potential damage or death of intestinal tissue. It often presents with severe abdominal pain, which may be disproportionate to physical examination findings. As the disease progresses, it can lead to intestinal necrosis, where parts of the intestine die due to lack of blood supply. This can result in symptoms such as nausea, vomiting, diarrhea, or bloody stools. If untreated, the condition can lead to severe complications, including infection and organ failure. Early recognition and intervention are crucial to prevent further progression of the disease.

Trial ID:

2023-508249-42-00

Protocol code:

APHP220818

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Oral Antibiotics Gentamicin and Metronidazole in Patients with Acute Mesenteric Ischemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?