Prehospital Antibiotics Against Sepsis Trial (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 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Open labelPrimary Purpose: Treatment
|Official Title:||A Prospective Randomized Controlled Trial to Investigate the Effects of Training Emergency Medical Services (EMS) Personnel in Recognizing and Initiating Treatment in the Prehospital Setting Together With Early Administration of Antibiotics for Patients Suspected of (Severe) Sepsis and Septic Shock|
- mortality [ Time Frame: 28 day mortality ]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 ]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 ]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 ]To compare whether there is a difference in the length of ICU stay in the standard treatment group versus the intervention group.
- time to adminstration of antibiotics (door to needle time) [ Time Frame: door to needle time at the ED: from entry at the ED till time to administration of antibiotics ]To compare whether there is a diference in time to administration of antibiotics in the usual care group opposed to baseline measurements prior to start of the trial of the trial.
|Actual Study Start Date:||June 2014|
|Study Completion Date:||June 2017|
|Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
No Intervention: standard care
Drug: Ceftriaxone 2000 mg
Ceftriaxone 2000 mg
Other Name: rocephin (roche)
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988428
|Amstelveen, Noord Holland, Netherlands, 1186 AM|
|Meander Medical Center|
|Academic Medical Centre|
|Onze Lieve Vrouwe Gasthuis Oost (former: St. Lucas Andreas Hospital)|
|Onze Lieve Vrouwe Gasthuis Oost|
|VU medical center|
|Rode Kruis Hospital|
|Albert Schweitzer Hospital|
|Maxima Medical Center|
|Spaarne Gasthuis, Haarlem|
|Maastricht Medical Center|
|Canisius Wilhemina Hospital|
|University Medical Center, Utrecht|
|VieCuri Medical Center|
|Principal Investigator:||Prabath WB Nanayakkara, MD, PhD||VU Medical Center (VUmc), Amsterdam|
|Principal Investigator:||P. Stassen, MD, Phd||Maastricht Medical Center, Maastricht|
|Principal Investigator:||E. Oskam, MD||Albert Schweitzer Hospital|
|Principal Investigator:||H. Nguyen, MD, PhD||Maasstad Hospital, Rotterdam|