Recruiting

Study on High-Dose Short-Course Antibiotics for Critically Ill Patients with Pneumonia, Intra-Abdominal, or Bloodstream Infections: Ceftriaxone, Linezolid, and Cefotaxime

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of different antibiotic treatments for patients who are critically ill with serious infections. The diseases being studied include pneumonia, intra-abdominal infections, and bloodstream infections. The trial will compare a short course of high-dose antibiotics to the conventional dose and duration of treatment. The antibiotics being tested in this study are ceftriaxone, cefotaxime, cefuroxime, piperacillin-tazobactam, and meropenem. These medications are commonly used to treat bacterial infections and will be administered through intravenous (IV) methods.

The purpose of the study is to determine if a shorter, high-dose treatment is as effective as the traditional longer treatment in terms of patient survival over 90 days. The study will involve patients who are in the intensive care unit (ICU) and are expected to stay there for a certain period. During the trial, some patients will receive the short course, high-dose treatment, while others will receive the conventional treatment. The study will monitor various outcomes, including survival rates, the occurrence of new infections, and the overall health and recovery of the patients.

Participants in the study will be closely monitored for any side effects or complications. The trial aims to find out if the shorter treatment can reduce the exposure to antibiotics without compromising the effectiveness of the treatment. This could potentially lead to better management of antibiotic use in critically ill patients, helping to prevent the development of antibiotic resistance and improve patient outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be informed about the study's purpose, which is to compare a short course, high dose of antimicrobial therapy with a conventional dose and duration in critically ill patients.
You will be asked to provide consent to participate in the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes checking for conditions like pneumonia, intra-abdominal infection, or bloodstream infection.
You must be admitted to the intensive care unit (ICU) and expected to stay for at least two more days.
Step 3
Treatment allocation
You will be randomly assigned to receive either a short course, high dose or a conventional dose and duration of antimicrobial therapy.
The specific medication you receive may include ceftriaxone, meropenem, cefotaxime, cefuroxime, or piperacillin and beta-lactamase inhibitor, administered intravenously.
Step 4
Medication administration
The medication will be administered through an intravenous (IV) line. The dosage and frequency will depend on the group you are assigned to.
The duration of the treatment will vary based on whether you are in the short course or conventional treatment group.
Step 5
Monitoring and follow-up
Throughout the trial, your health will be closely monitored. This includes checking for any side effects or changes in your condition.
Regular assessments will be conducted to evaluate the effectiveness of the treatment and any potential side effects.
Step 6
Completion of trial
The trial will conclude after a specified period, and you will be assessed for all-cause mortality within 90 days.
Additional follow-up may occur to monitor for any new infections or health changes.

Who can join the trial?

10 criteria

Must be 18 years or older.
Must have or be suspected to have one of the following infections: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-acquired pneumonia (VAP), intra-abdominal infection (IAI), or bloodstream infection (BSI). These are types of lung, abdominal, or blood infections.
Must be receiving or have started treatment with one of these antibiotics: ceftriaxone, cefotaxime, cefuroxime, piperacillin-tazobactam, or meropenem. These are medicines used to treat infections.
Treatment can be based on symptoms or specific test results.
Must be admitted to the Intensive Care Unit (ICU) and expected to stay there for at least two more days.
The study treatment, which involves either a short course with a high dose or a conventional dose and duration, must be suitable for the patient. Patients with certain infections that need higher doses or longer treatment, like endocarditis (heart infection), Staphylococcus aureus bacteremia (a type of blood infection), or osteomyelitis (bone infection), cannot participate.
Must have had one or more of the following organ problems in the last 24 hours and still ongoing:
- Mean Arterial Pressure (MAP) less than 60 mmHg for at least 1 hour. MAP is a measure of blood pressure.
- Need for vasopressors (medicines that raise blood pressure) for more than 4 hours.
- Need for breathing support using high-flow oxygen, CPAP, BiPAP, or a ventilator for at least 1 hour.
- Serum creatinine level greater than 220 µmol/L or 2.49 mg/dL. This is a measure of kidney function.

Who cannot join the trial?

6 criteria

Patients with **bacterial infections** or **mycoses** (fungal infections) cannot participate.
Patients who are not critically ill with **pneumonia** (lung infection), **intra-abdominal infection** (infection inside the belly), or **bloodstream infection** (infection in the blood) are excluded.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups are excluded.
Patients who are not male or female are excluded.
Patients who are not considered part of a vulnerable population cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Algemeen Ziekenhuis Delta
Verified
Roeselare, Belgium
Sint Franciscus Vlietland Groep Stichting
Responsive
Rotterdam, The Netherlands
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

Antimicrobials are medicines used to treat infections caused by bacteria, viruses, fungi, or parasites. In this clinical trial, the focus is on using these medicines to treat critically ill patients with conditions like pneumonia, intra-abdominal infections, or bloodstream infections. The trial is comparing a shorter course of high-dose antimicrobial treatment to the usual longer course with standard doses. The goal is to see if the shorter treatment is just as effective in helping patients recover, while also reducing the amount of medicine they are exposed to. This could potentially lead to fewer side effects and a lower risk of developing resistance to the medicines.

What is already known about the treatment

High Dose Antimicrobials – This medication is administered in a high dose over a short course to treat bacterial infections and mycoses, particularly in critically ill patients with pneumonia, intra-abdominal infection, or bloodstream infection. Currently, it is being studied in clinical trials to compare its effectiveness and safety against conventional antimicrobial treatments. The main goal is to see if this approach can achieve similar health outcomes while reducing the overall exposure to antimicrobials. At the molecular level, these antimicrobials work by targeting and disrupting essential processes in bacteria, such as cell wall synthesis or protein production, leading to the elimination of the infection. They are classified as antibiotics, which are drugs used to treat bacterial infections.

Investigated diseases

Pneumonia
Pneumonia is an infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus. It can cause symptoms such as cough, fever, chills, and difficulty breathing. The disease can be caused by a variety of organisms, including bacteria, viruses, and fungi. As the infection progresses, it can lead to severe respiratory distress and reduced oxygen levels in the blood. In some cases, pneumonia can cause complications like pleurisy or lung abscesses. The progression and severity can vary depending on the individual's health and the causative organism.
Intra-abdominal Infection (IAI)
Intra-abdominal infection refers to a group of infections that occur within the abdominal cavity. These infections can involve any of the organs within the abdomen, such as the stomach, intestines, liver, or pancreas. The condition often results from a breach in the integrity of the gastrointestinal tract, leading to the spread of bacteria. Symptoms may include abdominal pain, fever, and signs of systemic infection. As the infection progresses, it can lead to complications such as abscess formation or peritonitis. The severity and progression depend on the source and extent of the infection.
Bloodstream Infection (BSI)
Bloodstream infection, also known as bacteremia, occurs when bacteria enter the bloodstream, potentially leading to systemic infection. This condition can arise from infections in other parts of the body, such as the lungs or urinary tract, or from medical procedures. Symptoms may include fever, chills, and low blood pressure. As the infection progresses, it can lead to sepsis, a severe and widespread inflammatory response. The progression and impact of the infection can vary based on the individual's health and the type of bacteria involved.