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Prehospital Antibiotics Against Sepsis Trial (PHANTASi)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by VU University Medical Center
Sponsor:
Collaborators:
Stichting Nuts Ohra
Nederlandse Internisten Vereniging ( Dutch Association of Internists)
Information provided by (Responsible Party):
Prabath W.B. Nanayakkara, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01988428
First received: November 5, 2013
Last updated: September 23, 2015
Last verified: September 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 VU University Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2200
Study Start Date: June 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988428

Contacts
Contact: Prabath Nanayakkara, M.D, PhD 0031204446905 p.nanayakkara@vumc.nl
Contact: Nadia Alam, M.D. 0031204444362 n.alam@vumc.nl

Locations
Netherlands
Amstelland Ziekenhuis Recruiting
Amstelveen, Noord Holland, Netherlands, 1186 AM
Principal Investigator: G.J. Timmers, MD         
Meander Medical Center Not yet recruiting
Amersfoort, Netherlands
Principal Investigator: P. Luik, MD         
Academic Medical Centre Recruiting
Amsterdam, Netherlands
Principal Investigator: Frits Holleman, MD, PhD         
BovenIJ hospital Recruiting
Amsterdam, Netherlands
Principal Investigator: N Posthuma, MD, PhD         
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, Netherlands
Principal Investigator: W.E.M Schouten, MD         
St. Lucas Andreas Hospital Recruiting
Amsterdam, Netherlands
Principal Investigator: J Veenstra, MD, PhD         
VU medical center Recruiting
Amsterdam, Netherlands
Contact: Nadia Alam, MD    0031204444362    n.alam@vumc.nl   
Principal Investigator: Prabath Nanayakkara, MD, PhD         
Rijnstate Hospital Not yet recruiting
Arnhem, Netherlands
Principal Investigator: J. Holkema, MD         
Rode Kruis Hospital Recruiting
Beverwijk, Netherlands
Principal Investigator: T.C. Cheung, MD         
Amphia Hospital Not yet recruiting
Breda, Netherlands
Principal Investigator: G. Buunk, MD, PhD         
Albert Schweitzer Hospital Recruiting
Dordrecht, Netherlands
Principal Investigator: E Oskam, MD         
Gelderse Vallei Recruiting
Ede, Netherlands
Principal Investigator: A van Zanten, MD, PhD         
Catharina Hospital Not yet recruiting
Eindhoven, Netherlands
Principal Investigator: H. Ammerlaan, MD         
Maxima Medical Center Not yet recruiting
Eindhoven, Netherlands
Principal Investigator: H.R. Haak, MD, PhD         
Principal Investigator: A van der Honing, MD         
St.Anna Hospital Not yet recruiting
Geldrop, Netherlands
Principal Investigator: A Toorians, MD, PhD         
Spaarne Gasthuis, Haarlem Recruiting
Haarlem, Netherlands
Principal Investigator: B Kors, MD, PhD         
Elkerliek Hospital Not yet recruiting
Helmond, Netherlands
Principal Investigator: J. Frenken, MD         
Spaarne Gasthuis Recruiting
Hoofddorp, Netherlands
Principal Investigator: G.H. Louis-Wattel, MD         
Maastricht Medical Center Recruiting
Maastricht, Netherlands
Principal Investigator: P. Stassen, MD, PhD         
St.Antonius Hospital Not yet recruiting
Nieuwegein, Netherlands
Principal Investigator: W. Jellema, MD, PhD         
Haven Hospital Recruiting
Rotterdam, Netherlands
Principal Investigator: L. Slobbe, MD, PhD         
Principal Investigator: M. de Melo, MD         
Ikazia Hospital Recruiting
Rotterdam, Netherlands
Principal Investigator: A. Dees, MD, PhD         
Principal Investigator: G. Carels, MD         
Principal Investigator: M. Wabbijn, MD         
Maasstad Hospital Recruiting
Rotterdam, Netherlands
Principal Investigator: T.T.H. van Leeuwen-Nguyen, MD         
Principal Investigator: M.A. van Dorpel, MD, PhD         
Principal Investigator: J Assink, MD         
St.Franciscus Gasthuis Recruiting
Rotterdam, Netherlands
Principal Investigator: A. Govers, MD         
Vlietland Hospital Recruiting
Schiedam, Netherlands
Principal Investigator: M.A.M Verhoeven, MD         
Zuyderland Hospital Not yet recruiting
Sittard - Geleen, Netherlands
Principal Investigator: H. van Westreenen, MD         
Principal Investigator: J. Buijs, MD         
Rivierenland Hospital Not yet recruiting
Tiel, Netherlands
Principal Investigator: L Heesterman         
Diakonesse Hospital Not yet recruiting
Utrecht, Netherlands
Principal Investigator: S. Sankatsing, MD         
University Medical Center, Utrecht Not yet recruiting
Utrecht, Netherlands
Principal Investigator: H.A.H. Kaasjager, MD, PhD         
Principal Investigator: D Dekker, MD, PhD         
VieCuri Medical Center Not yet recruiting
Venlo, Netherlands
Principal Investigator: M. Hermans, MD         
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: F. Holleman, MD, Phd Academic Medical Center (AMC), Amsterdam
Principal Investigator: G.J Timmers, MD, Phd Amstelland Hospital, Amstelveen
Principal Investigator: W.E.M Schouten, MD Onze Lieve Vrouwe Gasthuis, Amsterdam
Principal Investigator: E. Oskam, MD Albert Schweitzer Hospital
Principal Investigator: N. Posthuma Bovenij Hospital, Amsterdam
Principal Investigator: A. Dees, MD, PhD Ikazia Hospital
Principal Investigator: H.R. Haak, MD, PhD Maxima Medisch Centrum, Eindhoven
Principal Investigator: H. Nguyen, MD, PhD Maasstad Hospital, Rotterdam
Principal Investigator: A. Govers, MD,PhD St.Franciscus Gasthuis, Rotterdam
Principal Investigator: J. Veenstra, MD, PhD St.Lucas Andreas Hospital, Amsterdam
Principal Investigator: B. Kors, MD, PhD Spaarne Gasthuis, Haarlem Zuid
Principal Investigator: T.C. Cheung, MD Rode Kruis Hospital, Beverwijk
Principal Investigator: G.H. Louis-Wattel, MD Spaarne Gasthuis, Hoofddorp
Principal Investigator: H. Ammerlaan, MD Catharina Hospital Eindhoven
Principal Investigator: A. Toorians, MD, PhD St.Anna Hospital, Geldrop
Principal Investigator: M.A.M Verhoeven, MD, PhD Vlietland Hospital, Rotterdam
Principal Investigator: B. Kanen Zaans Medisch Centrum, Zaandam
Principal Investigator: L. Slobbe, MD, PhD Haven 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 
Study First Received: November 5, 2013
Last Updated: September 23, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016