Prehospital Antibiotics Against Sepsis (PHANTASi)
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 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 emergency medical 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 multi-centre 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 multi-centre clinical trial nested within a step 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). Follow up of one year. QoL after six and twelve months after discharge.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Controlled Trial to Investigate the Effect of Early Administration of Antibiotics for Patients With Suspected Sepsis|
- mortality [ Time Frame: 28 day mortality ] [ Designated as safety issue: No ]To evaluate whether early, pre-hospital administration of antibiotics reduces 28-day mortality in patients referred to the ED with suspected severe sepsis or septic shock.
- length of stay [ Time Frame: an expected average of 5 weeks ] [ Designated as safety issue: No ]To compare whether there is a difference in the length of hospital stay in the standard treatment group versus the intervention group.
- quality of life [ Time Frame: one month after discharge hospital ] [ Designated as safety issue: No ]To evaluate whether early antibiotic administration has a beneficial effect on the quality of life after discharge from hospital. This will be measured one month after discharge using validated questionnaires (SF 36).
- Length of stay at ICU [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 5 weeks may vary from a few days to several weeks ] [ Designated as safety issue: No ]To compare whether there is a difference in the length of ICU stay in the standard treatment group versus the intervention group.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
No Intervention: standard care
ceftriaxone 2000 mg
Drug: Ceftriaxone 2000 mg
Ceftriaxone 2000 mg
Other Name: rocephin (roche)
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|Contact: Prabath Nanayakkara, M.D, PhDemail@example.com|
|VU medical center||Not yet recruiting|
|Amsterdam, Noord Holland, Netherlands, 1081 HZ|
|Principal Investigator:||Prabath Nanayakkara, MD, PhD||VU University Medical Center|
|Principal Investigator:||Patricia Stassen, MD, Phd||Maastricht Medical Center|
|Principal Investigator:||Stephanie Klein-Nagelvoort, MD, PhD||Erasmus Medical Center|
|Principal Investigator:||Frits Holleman, MD, Phd||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|