Trial record 7 of 400 for:    Open Studies | "Septicemia"

Prehospital Antibiotics Against Sepsis (PHANTASi)

This study is not yet open for participant recruitment.
Verified November 2013 by VU University Medical Center
Sponsor:
Collaborators:
Stichting Nuts Ohra
Maastricht University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Information provided by (Responsible Party):
Prabath W.B. Nanayakkara, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01988428
First received: November 5, 2013
Last updated: November 27, 2013
Last verified: November 2013
  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 multi-centre 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 multi-centre 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: March 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard care
standard care
Experimental: Antibiotics
ceftriaxone 2000 mg
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 meet two of the three SIRS criteria (abnormal temperature, abnormal pulse, abnormal respiratory rate);

Exclusion Criteria:

  • age <18 years
  • known or suspected allergy or hypersensitivity to ceftriaxone, to other cephalosporins , to a penicillin or to any other beta-lactam medicinal products
  • pregnancy
  • known severe renal and hepatic insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988428

Contacts
Contact: Prabath Nanayakkara, M.D, PhD 0031204446905 p.nanayakkara@vumc.nl

Locations
Netherlands
VU medical center Not yet recruiting
Amsterdam, Noord Holland, Netherlands, 1081 HZ
Sponsors and Collaborators
VU University Medical Center
Stichting Nuts Ohra
Maastricht University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Investigators
Principal Investigator: Prabath Nanayakkara, MD, PhD VU University Medical Center
Principal Investigator: Patricia Stassen, MD, Phd Maastricht Medical Center
Principal Investigator: Stephanie Klein-Nagelvoort, MD, PhD Erasmus Medical Center
Principal Investigator: Frits Holleman, MD, Phd Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  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: November 27, 2013
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 April 21, 2014