Paramedic administered antibiotics for patients with severe sepsis: Does this reduce the time to appropriate antibiotic therapy?

Phase 2

Recruiting

• Conditions: Sepsis; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12618000199213
• Lead Sponsor: Ambulance Victoria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-07
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from paramedic arrival at scene to appropriate administration of antibiotics. All relevant times (arrival at scene, arrival at hospital, drug administration) are logged in the electronic medical record. In both arms of the study, the time from paramedic arrival at scene will correspond to t=0. We will then determine the interval between this point and the administration of an antibiotic. In the intervention arm, this will be at the scene. In the control arm, this will be after arrival to hospital.<br><br>The appropriateness of the antibiotic administered, will be determined by in vitro susceptibility testing of any pathogens isolated from the patients. E.g. is the pathogen sensitive to the antibiotic. If not, the therapy will be considered inappropriate.[Time of administration of first antibiotic. This is clearly documented in the electronic record. the time of arrival of paramedics at the scene will be subtracted from this, such that the interval time to antibiotics can then be calculated.]