Study on Reducing Antibiotic Duration for Patients with Complicated Staphylococcus aureus Bacteremia Using Cefazolin Sodium, Flucloxacillin Sodium Monohydrate, and Clindamycin

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What is this study about?

This clinical trial is focused on studying the treatment of Staphylococcus aureus bacteremia, a serious infection caused by the bacteria Staphylococcus aureus in the bloodstream. The study is examining the effectiveness of three antibiotics: cefazolin sodium, flucloxacillin sodium monohydrate, and clindamycin. These medications are used to treat infections and are administered either through intravenous (IV) methods or orally, depending on the specific drug.

The purpose of the study is to determine if a shorter duration of antibiotic treatment, specifically four weeks, is as effective as the traditional six-week treatment for patients who have responded well to initial therapy. Participants in the study will receive one of the antibiotics mentioned above, or a placebo, to compare the outcomes. The study will monitor patients over a period to assess their response to the treatment and ensure there is no relapse of the infection.

Throughout the study, patients will be closely observed to ensure their safety and to evaluate the success of the therapy. The primary goal is to see if patients remain healthy and free from infection 180 days after starting the treatment. This research aims to provide insights into whether a shorter course of antibiotics can be just as effective, potentially leading to changes in how this infection is treated in the future.

1 initial treatment phase

Upon joining the study, the patient receives initial treatment for Staphylococcus aureus bacteremia (SAB).

The treatment involves intravenous administration of antibiotics with activity against the cultured S. aureus.

The antibiotics used may include cefazolin sodium, flucloxacillin sodium monohydrate, or clindamycin.

2 evaluation of clinical response

The patient’s response to the initial treatment is evaluated.

A satisfactory response is defined by a negative blood culture for S. aureus on day 8 of treatment, a decline in C-reactive protein (CRP) levels, and absence of fever between 7 and 14 days of treatment.

3 randomization and treatment duration

Patients who respond well to initial treatment are randomized to receive either 4 weeks or 6 weeks of total antibiotic treatment.

The objective is to determine if 4 weeks of treatment is as effective as 6 weeks.

4 follow-up and monitoring

Patients are monitored for 180 days after randomization to assess the success of therapy.

Success is defined by the patient being alive and having no evidence of disease relapse, confirmed by the absence of S. aureus in blood or other sterile sites.

Who Can Join the Study?

Adults with methicillin-sensitive complicated SAB. This means the patient has a type of bacterial infection in the blood caused by Staphylococcus aureus that can be treated with certain antibiotics.
At least one blood test must show the presence of Staphylococcus aureus.
There must be signs of the infection affecting organs or being deep-seated, such as conditions like endocarditis (infection of the heart lining), spondylodiscitis (infection of the spine), arthritis (joint infection), intravascular infection (infection in blood vessels), abscess (collection of pus), or other spread of infection.
Presence of risk factors for complicated SAB, such as:

Infection acquired outside of a hospital or healthcare setting.
Delay of more than 48 hours in starting proper treatment after the first positive blood test.
Positive blood test more than 48 hours after starting proper treatment.
Fever lasting 72 hours after the first positive blood test, with a temperature over 38 degrees Celsius for two days in a row.
Unknown source of the infection.

Good response to initial treatment, which includes:

Negative blood test for Staphylococcus aureus on the 8th day of proper antibiotic treatment.
Negative test results during surgery for patients with heart infection caused by Staphylococcus aureus.
Reduction of C-reactive protein (CRP), a marker of inflammation, to at least 50% below its highest level or to less than 30 mg/L within 14 days of treatment.
No fever (temperature below 38 degrees Celsius) for two days in a row between 7 and 14 days of treatment.

Both men and women can participate.
Participants should not be from vulnerable populations.

Who Cannot Join the Study?

Patients who have not responded well to the initial treatment for Staphylococcus aureus bacteremia. This means if the initial treatment did not work well for you, you cannot participate.
Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care, such as those with certain disabilities or conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Stichting OLVG	Amsterdam	The Netherlands
Frisius	Heerenveen	The Netherlands

Other Sites

Site Name	City	Country
Isala Klinieken Stichting	Zwolle	The Netherlands
Tergooiziekenhuizen	Hilversum	The Netherlands
Flevoziekenhuis Stichting	Almere	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Medical Center Haaglanden	Leidschendam	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
Lyagm Unlacrisoicb Mokjgjs Cyhyskq (tvkjg	Leiden	The Netherlands
Aaacxjbtb Ugv	Amsterdam	The Netherlands
Efavldg Uuhxffmqvejb Mvomwyp Crlkxmi Rcziehbng (vvoxhsb Mds	Rotterdam	The Netherlands
Sbs Ebcpqscfu Hnqksoxm Tazazkp	Tilburg	The Netherlands
Ahhpkxyhu Ubm	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.09.2020

Trial locations

Investigated drugs:

Antibiotic Treatment
This therapy involves using antibiotics to treat complicated Staphylococcus aureus bacteremia (SAB). The study is comparing two different durations of antibiotic treatment to see if a shorter 4-week course is as effective as a longer 6-week course for patients who have responded well to the initial treatment. Antibiotics are medications used to fight infections caused by bacteria, and in this trial, they are used to help clear the infection from the bloodstream.

Staphylococcus aureus bacteremia – This disease is an infection caused by the bacteria Staphylococcus aureus entering the bloodstream. It often begins with a localized infection, such as a skin infection, and can spread to other parts of the body through the blood. As the bacteria circulate, they can cause symptoms like fever, chills, and low blood pressure. If the infection progresses, it may lead to complications such as endocarditis, which is an infection of the heart valves, or osteomyelitis, an infection of the bone. The disease can be severe, requiring medical attention to prevent further spread and complications. It is important to monitor for signs of infection relapse, especially after initial improvement.

Trial ID:

2024-515398-90-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing Antibiotic Duration for Patients with Complicated Staphylococcus aureus Bacteremia Using Cefazolin Sodium, Flucloxacillin Sodium Monohydrate, and Clindamycin

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?