Study Comparing Benzylpenicillin and Cloxacillin for Treating Staphylococcus Aureus Blood Infection in Patients

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What is this study about?

This clinical trial is focused on studying the treatment of a blood infection caused by a type of bacteria known as Staphylococcus aureus. This condition is referred to as Staphylococcus aureus bacteremia. The study will compare two different treatments: bensylpenicillin and cloxacillin. Both medications are given as a solution for injection or infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to compare the outcomes of patients with this type of bacterial infection when treated with either bensylpenicillin or cloxacillin. Participants in the study will be randomly assigned to receive one of these two treatments. The study will monitor patients over a period to see how well they recover and if there are any complications or relapses within 90 days after finishing the antibiotic treatment.

The study will last for a maximum of seven days of treatment, and the main goal is to see if patients are alive and free of complications 90 days after treatment. Complications could include a return of the infection or the need to change or add antibiotics due to side effects or if the initial treatment does not work. This trial aims to provide valuable information on the effectiveness of these two antibiotics in treating Staphylococcus aureus bacteremia.

1 joining the study

Participation begins after meeting the criteria: being over 18 years old and having a penicillin-susceptible Staphylococcus aureus infection in the bloodstream. Consent is required.

2 treatment assignment

Participants are randomly assigned to receive either bensylpenicillin or cloxacillin for treatment. Both medications are administered as a solution for injection or infusion through a vein.

3 medication administration

Bensylpenicillin and cloxacillin are given intravenously. The specific dosage and frequency are determined by the healthcare provider based on individual needs and response to treatment.

4 monitoring and follow-up

Participants are monitored for any complications or adverse reactions during the treatment period. The primary goal is to be alive at day 90 without complications, such as a relapse within 90 days after completing the antibiotic treatment or needing to change or add antibiotics due to adverse events or treatment failure.

5 completion of the study

The study is estimated to end by February 1, 2028. Participants’ health outcomes are assessed to compare the effectiveness of bensylpenicillin versus cloxacillin in treating the infection.

Who Can Join the Study?

You must be older than 18 years.
You must have a condition called penicillin susceptible Staphylococcus aureus bacteraemia. This means you have a type of bacteria in your blood that can be treated with a specific antibiotic called penicillin.
You must be able to give informed consent, which means you understand the study and agree to participate.
Both men and women can participate.
People who may need extra care or protection, known as a vulnerable population, can also be included.

Who Cannot Join the Study?

Patients who are allergic to penicillin or cloxacillin cannot participate. An allergy means the body reacts badly to these medicines.
Patients with a history of severe allergic reactions to any antibiotics are excluded. Severe allergic reactions can include symptoms like difficulty breathing or swelling.
Patients who are pregnant or breastfeeding are not allowed to join the study. This is to ensure the safety of both the mother and the baby.
Patients with liver or kidney problems cannot participate. These organs are important for processing medications in the body.
Patients who are currently participating in another clinical trial are excluded. This is to avoid any interference with the results of the study.
Patients with a weakened immune system are not eligible. The immune system helps the body fight infections.
Patients who have had a recent heart attack or stroke cannot join. These are serious conditions affecting the heart and brain.
Patients with uncontrolled diabetes are excluded. Diabetes is a condition where blood sugar levels are too high.
Patients with a history of drug or alcohol abuse are not allowed to participate. Abuse means using these substances in a harmful way.
Patients who are unable to follow the study procedures or instructions are excluded. This is important for the accuracy of the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Region Vaestmanland	Vasteras	Sweden

Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Skane Helsingborg Hospital	Helsingborg	Sweden
Region Uppsala	Uppsala	Sweden
Region Blekinge	Karlskrona	Sweden
NU Hospital Group-Vaestra Goetalandsregionen	Trollhattan	Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Karolinska University Hospital	Solna	Sweden
Region Skane Kristianstad Central Hospital	Kristianstad	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Rviihk Shbiczgew	Stockholm	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.02.2024

Trial locations

Investigated drugs:

Bensylpenicillin is an antibiotic used to treat infections caused by bacteria. In this trial, it is being tested for its effectiveness in treating bloodstream infections caused by a specific type of bacteria called penicillin-susceptible Staphylococcus aureus. The goal is to see if it can successfully clear the infection and improve patient outcomes.

Cloxacillin is another type of antibiotic that is commonly used to treat infections caused by bacteria, including Staphylococcus aureus. In this trial, it is being compared to bensylpenicillin to determine which antibiotic is more effective in treating bloodstream infections caused by penicillin-susceptible Staphylococcus aureus. The trial aims to assess the clinical outcomes of patients treated with cloxacillin.

Staphylococcus aureus bacteremia – This disease is an infection caused by the bacteria Staphylococcus aureus entering the bloodstream. It can lead to symptoms such as fever, chills, and low blood pressure. The bacteria can spread to different parts of the body, potentially causing infections in organs or tissues. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may develop more severe complications. The body’s response to the infection can also lead to inflammation and damage to blood vessels. Monitoring and managing the infection is crucial to prevent further spread and complications.

Trial ID:

2023-506860-15-00

Protocol code:

COMeBAC

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Benzylpenicillin and Cloxacillin for Treating Staphylococcus Aureus Blood Infection in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?