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Study of Continuous Infusion of Cloxacillin Using Elastomeric Pump in Adult Patients with Staphylococcus Aureus Infection

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients with Staphylococcus aureus infection, which is a serious bacterial infection that can affect various parts of the body. The study will evaluate a treatment using cloxacillin, an antibiotic medication that fights bacterial infections. The medication will be given through continuous delivery into a vein using a special pump device called an elastomeric pump, which provides a steady flow of medication over time.

The purpose of the study is to check whether giving cloxacillin through continuous infusion maintains proper levels of the medication in the blood. This is important to ensure that patients receive enough medication to fight the infection without getting too much that could cause harmful effects. The study will monitor the amount of active medication in the blood at different times during treatment.

During the study, patients will receive cloxacillin continuously through the pump for up to 6 weeks. Blood samples will be taken at several points during the first two days of treatment to measure medication levels. The total daily dose of medication will be between 6 and 12 grams, delivered steadily throughout each 24-hour period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Starting continuous infusion treatment

    Your doctor will transition your treatment from regular infusions to a continuous infusion using a device called an elastomeric pump

    The medication cloxacillin will be administered at a dose of 6-12 grams over 24 hours

    This medication is used to treat infections caused by Staphylococcus aureus bacteria

  2. Step 2

    First blood sample collection

    A blood sample will be taken at the start of your continuous infusion

    This sample helps measure the initial levels of cloxacillin in your blood

  3. Step 3

    4-hour check

    A second blood sample will be collected approximately 4 hours after starting the continuous infusion

    This sample measures how the medication levels have stabilized in your blood

  4. Step 4

    24-hour check

    A third blood sample will be taken approximately 24 hours after starting the continuous infusion

    This helps monitor how your body maintains medication levels over a full day

  5. Step 5

    48-hour check

    A final blood sample will be collected approximately 48 hours after starting the continuous infusion

    This sample completes the monitoring of medication levels in your blood

Who can join the trial?

5 criteria

  • Patient must be 18 years of age or older
  • Patient's doctor must determine they are suitable to switch from regular intermittent antibiotic doses to continuous infusion of cloxacillin (an antibiotic medication) using an elastomeric pump (a small, portable device that delivers medication continuously)
  • Patient must be able to understand and sign an informed consent form to participate in the study
  • Both male and female patients can participate
  • Patient must be receiving a daily dose of 6-12 grams of cloxacillin for their infection

Who cannot join the trial?

11 criteria

  • Age below 18 years or above 65 years
  • Known allergic reactions to cloxacillin or other similar antibiotics
  • Severe kidney problems (as this may affect how the medication is processed in your body)
  • Severe liver problems (as this may affect how the medication is processed in your body)
  • Currently pregnant or breastfeeding
  • Having a blood infection caused by bacteria other than Staphylococcus aureus
  • Currently participating in another clinical trial
  • Unable to understand or follow study instructions
  • Having an elastomeric pump infection or complications at the insertion site
  • History of drug abuse that might interfere with study participation
  • Any condition that the study doctor believes would make participation unsafe
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Investigated drugs

Cloxacillin is an antibiotic medication that belongs to the penicillin family. It is used to treat various bacterial infections, particularly those caused by certain types of Staphylococcus bacteria. In this study, the medication is administered through a special device called an elastomeric pump, which delivers the medicine continuously into the bloodstream. This method of delivery is different from traditional intermittent dosing and may help maintain steady levels of the antibiotic in the body. The elastomeric pump is a small, portable device that uses an elastic balloon-like container to deliver medication at a constant rate through a thin tube connected to the patient's vein.

What is already known about the treatment

Cloxacillin - A penicillin-class antibiotic that is administered through continuous infusion using an elastomeric pump, specifically designed to treat infections caused by Staphylococcus aureus bacteria. This medication works by interfering with bacterial cell wall synthesis, preventing the growth and reproduction of bacteria, and belongs to the beta-lactam antibiotic family. Cloxacillin is particularly effective against penicillinase-producing staphylococci and is commonly used in hospital settings for treating serious staph infections, with its continuous infusion method helping to maintain steady therapeutic levels in the bloodstream.

Investigated diseases

Staphylococcus aureus infection - A bacterial infection caused by the Staphylococcus aureus organism, which can affect various parts of the body. The bacteria can live harmlessly on many skin surfaces, but when they enter the body through a cut or other wound, they can cause an infection. The infection typically begins with redness, swelling, and warmth in the affected area. S. aureus can cause a range of infections, from minor skin problems to infections in deeper tissues. The bacteria can spread through direct contact with an infected person or by touching contaminated objects or surfaces.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510423-30-00Estimated enrolment25 patients

sourced from the EU Clinical Trials Register and site verification

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