Prehospital Antibiotics Against Sepsis (PHANTASi)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by VU University Medical Center
Sponsor:
Collaborators:
Stichting Nuts Ohra
Dutch Society of Internal Medicine
Information provided by (Responsible Party):
Prabath W.B. Nanayakkara, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01988428
First received: November 5, 2013
Last updated: July 23, 2014
Last verified: July 2014
  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 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 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 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.


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 Effect of Early Administration of Antibiotics for Patients With Suspected Sepsis

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.


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
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
Contact: Nadia Alam, MD    +31 (0)20- 444 4362    n.alam@vumc.nl   
Principal Investigator: G.J. Timmers, MD         
VU medical center Recruiting
Amsterdam, Noord Holland, Netherlands, 1081 HZ
Contact: Nadia Alam, MD    0031204444362    n.alam@vumc.nl   
Principal Investigator: Prabath Nanayakkara, MD, PhD         
Academic Medical Centre Recruiting
Amsterdam, Noord Holland, Netherlands, 1105 AZ
Contact: Frits Holleman, MD       f.holleman@amc.uva.nl   
Contact: Nadia Alam, MD    +31 (0)20- 444 4362    n.alam@vumc.nl   
Principal Investigator: Frits Holleman, MD, PhD         
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, Noord Holland, Netherlands, 1091 AC
Contact: Tisja van den Brink, researchnurse    020-5993501    T.M.J.vandenBrink@olvg.nl)   
Contact: Nadia Alam, MD    +31 (0)20- 444 4362    n.alam@vumc.nl   
Principal Investigator: W.E.M Schouten, MD         
Sponsors and Collaborators
VU University Medical Center
Stichting Nuts Ohra
Dutch Society of Internal Medicine
Investigators
Principal Investigator: Prabath Nanayakkara, MD, PhD VU University Medical Center
Principal Investigator: Patricia Stassen, MD, Phd Maastricht Medical Center
Principal Investigator: Frits Holleman, MD, Phd Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: G.J Timmers, MD, Phd Amstelland Hospital, Amstelveen
Principal Investigator: W.E.M Schouten, MD Onze Lieve Vrouwe Gasthuis, Amsterdam
Principal Investigator: Erick Oskam, MD Albert Schweitzer Hospital
Principal Investigator: Nynke Posthuma Bovenij Hospital, Amsterdam
Principal Investigator: A Dees, MD, PhD Ikazia Hospital
Principal Investigator: H.R. Haak, MD, PhD Maxima Medical Center
Principal Investigator: H Nguyen, MD, PhD Maasstad Hospital
Principal Investigator: A Govers, MD,PhD St.Franciscus Gasthuis, Rotterdam
Principal Investigator: J Veenstra, MD, PhD St.Lucas Andreas Hospital
  More Information

No publications provided

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: July 23, 2014
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
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 26, 2014