Prehospital Antibiotics Against Sepsis Trial

Summary

Sepsis is one of the most frequent reasons for referral to emergency departments (EDs) worldwide. The incidence of sepsis is likely to rise in the upcoming years. Sepsis has a tendency to become more serious when left untreated with a high mortality rate, exceeding even those of myocardial infarction and stroke. Therefore, much effort has been put in to start with appropriate therapy as early as possible. Early goal-directed therapy (EGDT) in the emergency department with fluid resuscitation, administration of vasopressors/vasodilators and intravenous antibiotics in patients with severe sepsis and septic shock has indeed decreased mortality substantially. Emergency medical services (EMS) personnel have already made a significant difference in improving care for patients with acute coronary syndrome, multiple trauma and stroke. Patients with severe sepsis or septic shock could also benefit greatly from timely pre-hospital care. Earlier recognition and initiation of treatment by EMS personnel may improve survival even more.

Interestingly, the first hour of ED presentation seems to be the most critical hour. Administration of antibiotics and fluid resuscitation in the pre-hospital setting will reduce the time to administration substantially. In adults, to the best of our knowledge, no studies on the effect of pre-hospital administration of antibiotics have been performed. In children with meningitis, some uncontrolled studies show contradictory results, most probably due to bias by severity. We propose a non-blinded randomised multicentre clinical trial study on the efficacy of early, pre-hospital intravenous administration of broad spectrum antibiotics (ceftriaxone), which are effective against a wide variety of infectious pathogens that cause most common community-acquired infections) in patients referred to the ED with suspected severe sepsis or septic shock.

Objective: To evaluate whether early, pre-hospital administration of antibiotics, together with training of ambulance personnel in recognizing and initiating treatment reduces 28-day mortality in patients referred to the ED with suspected severe sepsis or septic shock

Study design: Non-blinded randomized multicentre clinical trial nested within a stepped wedge design

Study population: All patients above the age of 18 years, with suspected severe sepsis or septic shock and transferred to the ED by ambulance, are eligible for study inclusion

Intervention: prehospital antibiotics (ceftriaxone 2000 mg intravenously)

Main study parameters/endpoints: 28-day mortality, hospital length of stay, admission to intensive or medium care unit (ICU/MC), time to administration of antibiotics. Follow up of one year. QoL after one month after discharge.

Conditions

• Sepsis
• Severe Sepsis
• Septic Shock

Interventions

DRUG

Ceftriaxone 2000 mg

Ceftriaxone 2000 mg

Sponsors & Collaborators

• Stichting Nuts Ohra

  collaborator OTHER

• Nederlandse Internisten Vereniging ( Dutch Association of Internists)

  collaborator UNKNOWN

• Amsterdam UMC, location VUmc

  lead OTHER

Principal Investigators

• Prabath WB Nanayakkara, MD, PhD · VU Medical Center (VUmc), Amsterdam

• P. Stassen, MD, Phd · Maastricht Medical Center, Maastricht

• E. Oskam, MD · Albert Schweitzer Hospital, Dordrecht

• H. Nguyen, MD, PhD · Maasstad Hospital, Rotterdam

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2017-06-30

Completion

2017-06-30

Countries

• Netherlands

Study Locations