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Flucloxacillin Sodium Monohydrate

This article discusses the use of Flucloxacillin Sodium Monohydrate in clinical trials for treating complicated Staphylococcus aureus bacteremia (SAB). The focus is on a study called the SAFE-trial, which aims to determine if a shorter antibiotic treatment duration can be as effective as the standard longer treatment for patients with complicated SAB. This research is important for potentially improving patient care and reducing antibiotic use.

Table of Contents

What is Flucloxacillin Sodium Monohydrate?

Flucloxacillin Sodium Monohydrate is an antibiotic medication used to treat various bacterial infections. It belongs to a class of antibiotics called penicillins, which work by killing bacteria or preventing their growth[1]. This medication is also known by its brand name “Flucloxacillin 250mg Powder for Solution for Injection or Infusion”[1].

Medical Uses

Flucloxacillin is primarily used to treat infections caused by a type of bacteria called Staphylococcus aureus. One of the most serious conditions it treats is Staphylococcus aureus bacteremia (SAB), which is when these bacteria enter the bloodstream[1]. This condition can be life-threatening and requires prompt treatment.

Administration

Flucloxacillin Sodium Monohydrate is administered intravenously, which means it’s given directly into a vein[1]. This method allows the medication to enter your bloodstream quickly and start fighting the infection immediately.

Dosage

The dosage of Flucloxacillin can vary depending on the severity of the infection and other factors. However, the maximum daily dose is typically 12,000 mg (12 grams)[1]. The duration of treatment can last up to 6 weeks, but this may change based on how well you respond to the medication[1].

Current Clinical Trial

A clinical trial called the “SAFE-trial” is currently being conducted to study the use of Flucloxacillin in treating complicated Staphylococcus aureus bacteremia[1]. The main objective of this trial is to determine if a shorter treatment duration (4 weeks) is as effective as the standard 6-week treatment for patients who have responded well to initial therapy[1].

Eligibility Criteria for the Clinical Trial

To participate in this clinical trial, patients must meet certain criteria[1]:

  • Be an adult with methicillin-sensitive complicated SAB
  • Have evidence of organ involvement or deep-seated infection (such as endocarditis, an infection of the heart valves, or spondylodiscitis, an infection of the spine)
  • Have certain risk factors for complicated SAB, such as community-acquired infection or delayed treatment
  • Show a satisfactory response to initial treatment, including negative blood cultures and reduction in inflammation markers

Exclusion Criteria for the Clinical Trial

Certain conditions may prevent participation in the trial[1]:

  • Presence of infected prosthetic heart valves or other infected prosthetic materials that are not removed within 14 days of antibiotic therapy
  • Presence of large undrained abscesses (5 cm or more) after 14 days of antibiotic treatment
  • Pregnancy or breastfeeding

Primary Outcome of the Clinical Trial

The main goal of the trial is to assess the success of therapy 180 days after randomization[1]. Success is defined as:

  1. Patient survival
  2. No evidence of infection relapse, meaning no recurrence of symptoms or signs of infection with S. aureus found in blood or other normally sterile sites

This trial aims to potentially reduce the duration of antibiotic treatment for complicated SAB, which could lead to fewer side effects and improved quality of life for patients[1].

Aspect Details
Study Name SAFE-trial (Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteremia)
Main Objective To determine if 4 weeks of antibiotic treatment is non-inferior to 6 weeks in patients with complicated SAB
Drug Used Flucloxacillin Sodium Monohydrate (250mg Powder for Solution for Injection or Infusion)
Administration Route Intravenous
Maximum Daily Dose 12,000 mg
Maximum Treatment Period 6 weeks
Primary Outcome Success of therapy at 180 days after randomization
Key Inclusion Criteria Adults with methicillin-sensitive complicated SAB, evidence of organ involvement or deep-seated infection
Key Exclusion Criteria Infected prosthetic material not removed within 14 days, undrained large abscesses, pregnancy or lactation

FAQ

  • What is the main goal of the SAFE-trial? The main goal of the SAFE-trial is to determine whether 4 weeks of total antibiotic treatment is as effective as 6 weeks for patients with complicated Staphylococcus aureus bacteremia (SAB) who have responded well to initial treatment.
  • Who can participate in this clinical trial? Adults with methicillin-sensitive complicated SAB can participate if they meet specific criteria, such as having evidence of organ involvement or deep-seated infection, or having certain risk factors for complicated SAB.
  • What is Flucloxacillin Sodium Monohydrate and how is it used in this trial? Flucloxacillin Sodium Monohydrate is an antibiotic used to treat bacterial infections. In this trial, it's administered intravenously as part of the treatment for complicated Staphylococcus aureus bacteremia.
  • What is the primary outcome measured in this study? The primary outcome is the success of therapy, defined as the patient being alive and having no evidence of microbiologically confirmed disease relapse 180 days after randomization.
  • Are there any specific exclusion criteria for this trial? Yes, patients with infected prosthetic heart valves or other infected prosthetic material not removed within 14 days of antibiotic therapy, those with undrained abscesses of 5 cm or more, and pregnant or lactating women are excluded from the trial.

Ongoing Clinical Trials on Flucloxacillin Sodium Monohydrate

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Staphylococcus aureus bacteremia (SAB): A serious blood infection caused by the bacteria Staphylococcus aureus.
  • Methicillin-sensitive: Refers to bacteria that can be effectively treated with methicillin and similar antibiotics.
  • Complicated SAB: A more severe form of Staphylococcus aureus bacteremia, often involving organ involvement or deep-seated infections.
  • Endocarditis: An infection of the inner lining of the heart chambers and valves.
  • Spondylodiscitis: An infection affecting the spine, specifically the vertebrae and intervertebral discs.
  • C-reactive protein (CRP): A blood test that measures the level of inflammation in the body.
  • Prosthetic valve: An artificial heart valve used to replace a damaged or diseased natural valve.
  • Transesophageal echocardiogram (TEE): A type of heart scan that uses sound waves to create detailed images of the heart and its blood vessels.
  • Positron emission tomography (PET): An imaging test that uses a radioactive tracer to show how organs and tissues are functioning.
  • Microbiologically confirmed: Verified through laboratory testing that identifies specific microorganisms.

References

  1. http://clinicaltrials.eu/trial/study-on-reducing-antibiotic-duration-for-patients-with-complicated-staphylococcus-aureus-bacteremia-using-cefazolin-sodium-flucloxacillin-sodium-monohydrate-and-clindamycin/