Study on Preoperative Antibiotics for Patients with Acute Cholecystitis: Comparing Ertapenem, Ciprofloxacin, and Cefuroxime

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What is this study about?

This clinical trial is focused on studying the effects of antibiotics in patients with acute cholecystitis, which is an inflammation of the gallbladder. The study will compare the outcomes of using a single dose of antibiotics versus continuous antibiotic treatment before surgery. The antibiotics being tested include ertapenem (marketed as INVANZ), ciprofloxacin (marketed as Ciprofloxacin Fresenius Kabi), and cefuroxime (marketed as Cefuroxime Orion Pharma). These medications are administered intravenously, meaning they are given directly into a vein.

The purpose of the study is to determine which antibiotic approach is more effective in reducing the risk of infections after surgery in patients undergoing gallbladder removal due to acute cholecystitis. Participants in the study will be randomly assigned to receive either a single dose or continuous doses of antibiotics before their surgery. The study will monitor the rate of infections and other complications within 30 days after the surgery.

By participating in this study, researchers aim to gather valuable information that could improve treatment strategies for patients with acute cholecystitis. The study will also look at other factors such as the need to switch from a less invasive surgery to a more invasive one, the overall complication rate, and any side effects related to the antibiotics used. The findings from this study could help in making informed decisions about the best preoperative antibiotic treatment for patients with this condition.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either a single dose of antibiotics or continuous antibiotics before surgery.

2 receiving antibiotics

If you are in the single-dose group, you will receive a one-time dose of ertapenem (1 gram) through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein.

If you are in the continuous antibiotics group, you will receive ciprofloxacin (2 mg/ml) and cefuroxime (1.5 grams) through intravenous infusions. These medications will be administered continuously until your surgery.

3 undergoing surgery

You will undergo a surgical procedure called a cholecystectomy, which involves the removal of the gallbladder. This is done to treat your condition of mild or moderate acute cholecystitis.

4 postoperative monitoring

After the surgery, you will be monitored for any signs of infection or complications. The primary focus is to observe the rate of postoperative infectious complications within 30 days from the time you were assigned to a group.

Secondary observations include the need to switch from a less invasive laparoscopic surgery to an open surgery, any complications according to a specific classification system, and any adverse reactions related to the antibiotics.

5 follow-up period

You will have follow-up appointments to assess your recovery and any potential complications. This period lasts for 30 days after your surgery. During this time, your overall health and any reactions to the antibiotics will be evaluated.

Who Can Join the Study?

Patients must have been diagnosed with mild or moderate acute cholecystitis. This is a condition where the gallbladder is inflamed, and the severity is determined by specific guidelines called the Tokyo Guidelines.
Patients must be within the age range of 18 to 64 years old.
Both men and women can participate in the study.
Participants should not belong to any vulnerable population groups, which means they should not be in a situation that makes them more susceptible to harm or coercion.

Who Cannot Join the Study?

Patients with a history of allergic reactions to antibiotics cannot participate. An allergic reaction is when your body reacts badly to a substance, causing symptoms like rash, itching, or trouble breathing.
Patients who have had a recent surgery within the last 30 days are not eligible. Recent surgery means any operation you have had in the past month.
Patients with severe liver or kidney disease cannot join. Severe disease means your liver or kidneys are not working well, which can affect how your body handles medication.
Pregnant or breastfeeding women are not allowed to participate. This is to ensure the safety of both the mother and the baby.
Patients currently participating in another clinical trial are excluded. This is to avoid any interference between different study treatments.
Patients with immune system disorders are not eligible. An immune system disorder means your body’s defense system against infections is not working properly.
Patients with uncontrolled diabetes cannot participate. Uncontrolled diabetes means your blood sugar levels are not stable, which can affect your health during the study.
Patients with active infections other than acute cholecystitis are excluded. An active infection means you currently have an illness caused by bacteria, viruses, or other germs.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hoxwlzzr Ubbgzmsrpw Cmociow Hdoqqlcl	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	02.01.2025

Trial locations

Investigated drugs:

Antibiotics are medicines used to treat infections caused by bacteria. In this clinical trial, antibiotics are given to patients before they undergo surgery to remove their gallbladder, a procedure known as a cholecystectomy. The trial is investigating whether a single dose of antibiotics is as effective as continuous doses in preventing infections after the surgery. The goal is to see if taking fewer antibiotics can still protect patients from infections, which can help reduce side effects and the risk of antibiotic resistance.

Acute cholecystitis – Acute cholecystitis is an inflammation of the gallbladder, typically caused by a blockage of the cystic duct, often due to gallstones. This blockage leads to a buildup of bile, causing irritation and pressure within the gallbladder. The condition usually begins with sudden and severe pain in the upper right abdomen, which may radiate to the shoulder or back. As the inflammation progresses, symptoms can include fever, nausea, and vomiting. If untreated, the gallbladder can become infected or even rupture. The inflammation can lead to complications such as tissue death or the formation of pus within the gallbladder.

Trial ID:

2024-515958-24-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preoperative Antibiotics for Patients with Acute Cholecystitis: Comparing Ertapenem, Ciprofloxacin, and Cefuroxime

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?