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Study on How Kidney Function Estimates Help Adjust Cloxacillin Dosing in Patients with Staphylococcus aureus Bacteremia

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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 a condition known as Staphylococcus aureus bacteremia, which is a type of bacterial infection in the blood. The treatment being investigated is an antibiotic called cloxacillin. The purpose of the study is to determine if a measure of kidney function, known as the estimated glomerular filtration rate (eGFR), can help predict which patients might need adjustments in their cloxacillin dosage. This is done through a process called therapeutic drug monitoring (TDM), which involves checking the levels of the drug in the blood to ensure they are within a safe and effective range.

Participants in the study will receive cloxacillin through an intravenous route, meaning it will be administered directly into a vein. The study will monitor patients over a period of time to see how well the drug works and to check for any potential side effects. The researchers will pay special attention to how the drug levels relate to kidney function and whether patients reach the desired drug concentration in their blood. This will help in understanding if the standard dosing needs to be adjusted based on individual kidney function.

Throughout the study, various health markers will be observed, including any signs of kidney damage or changes in mental status, such as confusion or tremors. The study will also consider factors like age, weight, and other health conditions that might affect the treatment. By gathering this information, the study aims to improve the way cloxacillin is used to treat Staphylococcus aureus bacteremia, ensuring it is both safe and effective for patients with different levels of kidney function.

The research process

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

  1. Step 1

    Joining the study

    Participation begins after providing written consent.

    Eligibility requires being 18 years or older, having a blood culture positive for Staphylococcus aureus taken within 72 hours before inclusion, and starting treatment with cloxacillin either at inclusion or within the previous 72 hours.

  2. Step 2

    Treatment initiation

    Receive cloxacillin intravenously. The dosage and frequency are determined by the medical team based on individual needs.

  3. Step 3

    Monitoring and assessment

    On days 2 and 7, blood tests are conducted to measure cloxacillin levels and assess kidney function.

    The goal is to achieve a specific treatment target related to drug concentration and kidney function.

  4. Step 4

    Safety evaluations

    Daily monitoring from day 1 to day 7 for signs of kidney injury and any new effects on the central nervous system, such as changes in consciousness or seizures.

    These observations are related to cloxacillin levels in the body.

  5. Step 5

    Additional assessments

    On days 2 and 7, additional tests may be conducted to measure exploratory biomarkers in urine and plasma.

    These tests help understand the body's response to the treatment.

  6. Step 6

    Completion of participation

    Participation in the study concludes after the final assessments on day 7.

    The study aims to finish by June 30, 2026.

Who can join the trial?

4 criteria

  • The person must have given their written consent to participate in the trial. This means they agree to join the study and have signed a form to show this.
  • The person must be 18 years old or older.
  • The person must have a primary blood test showing the presence of S. aureus bacteria, taken within 72 hours before joining the study. S. aureus is a type of bacteria that can cause infections.
  • The person must be receiving treatment with cloxacillin, which should have started at the time of joining the study or within the previous 72 hours. Cloxacillin is a type of antibiotic used to treat bacterial infections.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Staphylococcus aureus bacteremia cannot participate. This is a type of bacterial infection in the blood.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

Cloxacillin is an antibiotic used in this trial to treat patients with Staphylococcus aureus bloodstream infections. The study aims to determine if the standard dosing of cloxacillin is effective and if kidney function can predict the need for dose adjustments.

What is already known about the treatment

Cloxacillin – Cloxacillin is administered orally or intravenously, depending on the severity of the infection. It is currently used in medical practice and is well-documented in medical literature as an effective treatment for bacterial infections, particularly those caused by Staphylococcus aureus. The main therapeutic indication for cloxacillin is the treatment of Staphylococcus aureus bacteremia. At the molecular level, cloxacillin works by inhibiting the synthesis of bacterial cell walls, which ultimately leads to the death of the bacteria. It belongs to the pharmacological class of penicillinase-resistant penicillins, which are a subgroup of beta-lactam antibiotics.

Investigated diseases

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. As the infection progresses, it may spread to other parts of the body, potentially affecting organs and tissues. The bacteria can form abscesses or cause inflammation in areas like the heart, bones, or joints. The severity of the disease can vary, with some individuals experiencing mild symptoms while others may develop more serious complications. The progression of the disease depends on factors such as the individual's immune system and the presence of any underlying health conditions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505148-20-00Estimated enrolment90 patientsSponsorRegion Oestergoetland

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).