Study on Ceftriaxone Dosing for Patients with Severe Community-Acquired Pneumonia

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What is this study about?

This clinical trial is focused on studying a condition known as severe community-acquired pneumonia, which is a serious lung infection that people can get outside of a hospital setting. The treatment being tested in this study is a medication called ceftriaxone, which is an antibiotic given as a solution for injection. The purpose of the study is to evaluate the benefits and safety of different dosing schedules of ceftriaxone in patients who are critically ill with this type of pneumonia.

Participants in the study will receive ceftriaxone either every 24 hours or every 12 hours, depending on their risk for a condition called augmented renal clearance (ARC). ARC is when the kidneys clear drugs from the body faster than usual, which can affect how well the medication works. The study will monitor various outcomes, such as the length of stay in the intensive care unit (ICU), survival rates, and the effectiveness of the treatment in clearing the infection.

The study will also look at other factors, such as the number of days patients are free from needing a ventilator, the presence of any side effects, and changes in certain blood markers that indicate infection. The trial aims to provide valuable information on how to best use ceftriaxone to treat severe community-acquired pneumonia in critically ill patients.

1 joining the trial

Participation begins with obtaining voluntary written informed consent. This can be done by the participant or their legally authorized representative. Consent must be obtained before or within 72 hours after oral consent prior to any screening procedures.

Participants must use highly effective methods of birth control during the trial. This includes options like implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), true sexual abstinence, or having a vasectomized partner.

Participants must be 18 years or older and have a confirmed diagnosis of severe community-acquired pneumonia (sCAP) as defined by current guidelines.

2 treatment administration

The treatment involves the administration of ceftriaxone, a medication used to treat bacterial infections. It is given through an intravenous infusion.

The dosage of ceftriaxone is 2 grams. The frequency of administration is either every 24 hours (q24h) or every 12 hours (q12h), depending on the patient’s risk for developing augmented renal clearance (ARC).

The treatment is specifically for patients with severe community-acquired pneumonia who are admitted to an intensive care unit (ICU).

3 monitoring and evaluation

The primary endpoint of the trial is the length of stay in the ICU.

Secondary endpoints include changes in the Sequential Organ Failure Assessment (SOFA) score, ICU mortality, 28-day mortality, hospital length of stay, and the number of days alive and free from the ICU and ventilator at day 28.

Other evaluations include clinical cure and microbial eradication at day 14, emergence of resistance, pharmacokinetic/pharmacodynamic (PK/PD) target attainment, safety assessment, and measurement of procalcitonin and C-reactive protein concentrations.

4 trial duration

The estimated recruitment start date for the trial is January 1, 2024.

The trial is expected to end by January 1, 2026.

Who Can Join the Study?

The participant or their legally authorized representative must provide written informed consent before or within 72 hours after giving oral consent for any screening procedures. This means they agree to join the study after understanding what it involves.
Participants must use highly effective birth control methods. These are methods that have a very low chance of failing, like implants, injections, certain birth control pills, some intrauterine devices (IUDs), not having sex, or having a partner who has had a vasectomy.
Participants must be 18 years or older at the start of the study.
Participants must have a confirmed diagnosis of severe Community-Acquired Pneumonia (sCAP), according to the guidelines from the Infectious Diseases Society of America (IDSA) and the American Thoracic Society (ATS).
Participants must have started treatment with ceftriaxone for their severe Community-Acquired Pneumonia (sCAP). Ceftriaxone is a type of antibiotic used to treat infections.
Participants must be planned to be admitted to an Intensive Care Unit (ICU). This is a special hospital ward for patients who need close monitoring and support.

Who Cannot Join the Study?

Patients who are not critically ill with Severe Community-Acquired Pneumonia cannot participate. This means the study is only for those who are very sick with a specific type of lung infection.
Patients who are not at risk for developing ARC (Augmented Renal Clearance) cannot participate. ARC is a condition where the kidneys clear drugs from the body faster than normal.
Patients who do not fall within the specified age ranges cannot participate. The study is for certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is for specific groups of people.
Patients who are not male or female cannot participate. The study includes both men and women.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.01.2024

Trial locations

Investigated drugs:

Ceftriaxone

Ceftriaxone is an antibiotic used to treat severe community-acquired pneumonia. In this trial, it is being studied to see if adjusting the frequency of doses based on kidney function can improve treatment outcomes for critically ill patients. The study compares giving the medication every 24 hours versus every 12 hours to determine which schedule is more effective and safe.

Investigated diseases:

Pneumonia

Severe Community-Acquired Pneumonia – This is a serious lung infection acquired outside of a hospital setting. It typically begins with symptoms like cough, fever, and difficulty breathing. As the disease progresses, it can lead to severe respiratory distress and may require hospitalization. The infection can spread to the bloodstream, causing further complications. In severe cases, patients may need intensive care support, including mechanical ventilation. The condition is more common in individuals with weakened immune systems or underlying health issues.

Trial ID:

2022-502013-28-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ceftriaxone Dosing for Patients with Severe Community-Acquired Pneumonia

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