None listed
Conditions
Brief summary
In patients with severe sepsis, we aim to conduct a Phase 2, prospective, randomised controlled trial of intravenous antibiotics administered by paramedics in the prehospital setting, compared with standard care. Sepsis is a common reason for presentation to an emergency department and has an annual incidence in adults of up to 300 cases per 100,000 persons per year. It is known that patients in the community with severe sepsis are more likely to arrive at hospital by ambulance than by other means. Importantly, existing evidence from observational studies suggests that increased time to administration of antibiotics in these patients has a significant impact on mortality. However there is currently a considerable period of time between arrival of the patient with sepsis at the emergency department and administration of antibiotics. As such, this study aims to test the hypothesis that, in patients with severe sepsis when evaluated by paramedics, prehospital administration of antibiotics will result in a significant reduction in the time to appropriate antibiotic treatment when compared with standard care.
Interventions
Intervention arm - Paramedic administration of 2g intravenous Ceftriaxone sodium for patients with severe sepsis. Compliance with the intervention will be monitored by reconciling all study drug administration through the Ambulance Victoria Pharmacy.
Sponsors
Ambulance Victoria
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients are eligible to be enrolled in the PASS study if they present with a history suggestive of infection, are greater than or equal to 18 years of age, are transported to a participating hospital, and who meet the following initial paramedic VSS criteria: • SBP<100mmHg; and • GCS<15
Exclusion criteria
• Female known to be pregnant • Suspected or known allergy to any cephalosporin antibiotics (e.g. Ceftriaxone) and confirmed severe allergic reactions to penicillin (e.g. Anaphylaxis or Angio oedema). If unable to confirm severe allergic reactions to penicillin and the patient meets the inclusion criteria (and no other exclusion criteria) enrolment can occur. • Suspected meningococcal infection (will receive ceftriaxone as standard care) • Deranged clinical parameters considered likely to be from a non-infective cause (such as dehydration, acute coronary syndrome, trauma, anaphylaxis) • Already receiving IV antibiotics (“Hospital in the home” patients) • Cystic Fibrosis • Transplant recipient of solid organs • Cancer patients receiving active treatment • Patient has been an in-patient at a health-care facility in the last 7-days
Outcome results
None listed