Prehospital Antibiotics Against Sepsis Trial
PHANTASi
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
1 other identifier
interventional
2,672
1 country
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable sepsis
Started Jun 2014
Typical duration for not_applicable sepsis
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2013
CompletedFirst Posted
Study publicly available on registry
November 20, 2013
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 15, 2017
June 1, 2017
3 years
November 5, 2013
June 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
28 day mortality
Secondary Outcomes (1)
length of stay
an expected average of 5 weeks
Other Outcomes (3)
quality of life
one month after discharge hospital
Length of stay at ICU
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
time to adminstration of antibiotics (door to needle time)
door to needle time at the ED: from entry at the ED till time to administration of antibiotics
Study Arms (2)
standard care
NO INTERVENTION* standard care * training of ambulance personnel in recognizing sepsis and initiating pre-hospital treatment
Antibiotics
EXPERIMENTAL* ceftriaxone 2000 mg (after taking bloodcultures) * training of ambulance personnel in recognizing sepsis and initiating pre-hospital treatment
Interventions
Eligibility Criteria
You may qualify if:
- \- All patients older than 18 years who are suspected of sepsis AND have an abnormal temperature (\>38 degrees Celsius or \< 36 degrees Celsius) in combination with at least one of the following two SIRS criteria, abnormal pulse (\> 90 beats per minute) and/or abnormal respiratory rate (\> 20 per minutes)
You may not qualify if:
- Age \<18 years
- Known severe allergic reaction to ceftriaxone or to other beta lactam antibiotics
- Known pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Amstelland Ziekenhuis
Amstelveen, North Holland, 1186 AM, Netherlands
Meander Medical Center
Amersfoort, Netherlands
Academic Medical Centre
Amsterdam, Netherlands
BovenIJ hospital
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis Oost (former: St. Lucas Andreas Hospital)
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis Oost
Amsterdam, Netherlands
VU medical center
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Rode Kruis Hospital
Beverwijk, Netherlands
Amphia Hospital
Breda, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Gelderse Vallei
Ede, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Maxima Medical Center
Eindhoven, Netherlands
St.Anna Hospital
Geldrop, Netherlands
Zuyderland Hospital
Geleen, Netherlands
Beatrix Hospital
Gorinchem, Netherlands
Spaarne Gasthuis, Haarlem
Haarlem, Netherlands
Zuyderland Hospital
Heerlen, Netherlands
Elkerliek Hospital
Helmond, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Maastricht Medical Center
Maastricht, Netherlands
St.Antonius Hospital
Nieuwegein, Netherlands
Canisius Wilhemina Hospital
Nijmegen, Netherlands
Bravis Hospital
Roosendaal, Netherlands
Haven Hospital
Rotterdam, Netherlands
Ikazia Hospital
Rotterdam, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
St.Franciscus Gasthuis
Rotterdam, Netherlands
Vlietland Hospital
Schiedam, Netherlands
Rivierenland Hospital
Tiel, Netherlands
Diakonesse Hospital
Utrecht, Netherlands
University Medical Center, Utrecht
Utrecht, Netherlands
VieCuri Medical Center
Venlo, Netherlands
Related Publications (3)
Ling L, Joynt GM, Lipman J. A narrative review on antimicrobial therapy in septic shock: updates and controversies. Curr Opin Anaesthesiol. 2021 Apr 1;34(2):92-98. doi: 10.1097/ACO.0000000000000954.
PMID: 33470662DERIVEDNannan Panday RS, Lammers EMJ, Alam N, Nanayakkara PWB. An overview of positive cultures and clinical outcomes in septic patients: a sub-analysis of the Prehospital Antibiotics Against Sepsis (PHANTASi) trial. Crit Care. 2019 May 21;23(1):182. doi: 10.1186/s13054-019-2431-8.
PMID: 31113475DERIVEDAlam N, Oskam E, Stassen PM, Exter PV, van de Ven PM, Haak HR, Holleman F, Zanten AV, Leeuwen-Nguyen HV, Bon V, Duineveld BAM, Nannan Panday RS, Kramer MHH, Nanayakkara PWB; PHANTASi Trial Investigators and the ORCA (Onderzoeks Consortium Acute Geneeskunde) Research Consortium the Netherlands. Prehospital antibiotics in the ambulance for sepsis: a multicentre, open label, randomised trial. Lancet Respir Med. 2018 Jan;6(1):40-50. doi: 10.1016/S2213-2600(17)30469-1. Epub 2017 Nov 28.
PMID: 29196046DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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, Dordrecht
- PRINCIPAL INVESTIGATOR
H. Nguyen, MD, PhD
Maasstad Hospital, Rotterdam
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
November 5, 2013
First Posted
November 20, 2013
Study Start
June 1, 2014
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 15, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share