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Prehospital Antibiotics Against Sepsis Trial (PHANTASi)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01988428
First Posted: November 20, 2013
Last Update Posted: June 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Stichting Nuts Ohra
Nederlandse Internisten Vereniging ( Dutch Association of Internists)
Information provided by (Responsible Party):
Prabath W.B. Nanayakkara, VU University Medical Center
  Purpose

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.


Condition Intervention
Sepsis Severe Sepsis Septic Shock Drug: Ceftriaxone 2000 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open label
Primary 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

Resource links provided by NLM:


Further study details as provided by Prabath W.B. Nanayakkara, VU University Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 2672
Actual Study Start Date: June 2014
Study Completion Date: June 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard care
  • standard care
  • training of ambulance personnel in recognizing sepsis and initiating pre-hospital treatment
Experimental: Antibiotics
  • ceftriaxone 2000 mg (after taking bloodcultures)
  • training of ambulance personnel in recognizing sepsis and initiating pre-hospital treatment
Drug: Ceftriaxone 2000 mg
Ceftriaxone 2000 mg
Other Name: rocephin (roche)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

  • Age <18 years
  • Known severe allergic reaction to ceftriaxone or to other beta lactam antibiotics
  • Known pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988428


Locations
Netherlands
Amstelland Ziekenhuis
Amstelveen, Noord Holland, Netherlands, 1186 AM
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
Sponsors and Collaborators
VU University Medical Center
Stichting Nuts Ohra
Nederlandse Internisten Vereniging ( Dutch Association of Internists)
Investigators
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
  More Information

Responsible Party: Prabath W.B. Nanayakkara, Doctor, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01988428     History of Changes
Other Study ID Numbers: NL42001.029.13
First Submitted: November 5, 2013
First Posted: November 20, 2013
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prabath W.B. Nanayakkara, VU University Medical Center:
sepsis
severe sepsis
septic shock

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Ceftriaxone
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents