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Antibiotic Administration and Blood Culture Positivity in Severe Sepsis and Septic Shock

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01867905
First received: May 29, 2013
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

Sepsis is a significant cause health care expenditure and carries an extremely high rate of morbidity and mortality if not treated appropriately. From 1979 to 2000, sepsis resulted in over 10 million admissions to hospital in the United States with a mortality rate of 17.9 to 27.8 percent. In Canada, it is estimated that the incidence of sepsis from 2008-2009 was 103.3 per 100,000 per year.

Advances in the multifaceted management of sepsis in recent years have resulted in improved clinical outcomes. However, the cornerstone of sepsis management relies on the prompt administration of appropriate antibiotics. Current clinical practice suggests that antibiotic administration can be delayed up to 45 minutes in order to obtain blood cultures, whose results have a profound impact on the type and duration of antimicrobial therapy. Unfortunately, this recommendation is based on very little evidence and the investigators have found that potential life-saving treatment is often delayed in order to abide by it. Furthermore, recent data suggest that mortality could be increased by approximately 5% by delaying antibiotic administration for that time period.

The investigators therefore wish to organize a prospective, multi-centre trial in order to identify the effect of antibiotic administration on blood culture positivity in patients presenting with severe sepsis or septic shock. Other objectives will be to elucidate which patient factors, including age, co-morbid conditions and clinical presentation, as well as antibiotic choice will affect blood culture results.

This study will be conducted in the emergency departments at St. Paul's Hospital (SPH), Vancouver General Hospital (VGH), and Lion's Gate Hospital (LGH). Patients identified for the aforementioned conditions will be treated as per routine hospital protocol. If the patient is deemed eligible for the study, a second set of blood of blood cultures will subsequently be drawn ideally between 30 and 60 minutes after the administration of antibiotic therapy. Subject demographic data will be collected pertaining to age, comorbid immunocompromised conditions, vital signs, laboratory tests pertaining to end organ dysfunction, suspected source of sepsis, the type antibiotics administered and the timing of antimicrobial administration with respect to the second set of blood cultures taken.

Our hypothesis is that blood culture positivity in patients presenting with severe sepsis and septic shock will not be altered significantly by antibiotic therapy. If so, our study would strongly argue against delaying life-saving therapy and would thus greatly improve patient care in our local emergency rooms. If incorrect, our study would be the first to demonstrate the benefit of obtaining blood cultures before antibiotic therapy and would strengthen current recommendations.


Condition
Severe Sepsis
Septic Shock
Bacteremia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Antibiotic Administration on Blood Culture Positivity in Patients With Severe Sepsis and Septic Shock: a Prospective Multicenter Observational Trial.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The effect of antibiotic administration on blood culture positivity in patients with severe sepsis and septic shock: a prospective multicenter observational trial. [ Time Frame: Four months ] [ Designated as safety issue: No ]
    The primary outcome is the measure of blood culture positivity before and after antibiotic administration.


Biospecimen Retention:   Samples With DNA

Blood cultures


Estimated Enrollment: 361
Study Start Date: June 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Severe sepsis and septic shock
Patients who present in severe sepsis or septic shock will have blood cultures taken before and after antibiotic administration. The antibiotic choice will be determined by the emergency physician and the patients will be treated as per routine hospital protocol. No therapeutic interventions will be administered.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients (age > 18) who present to the emergency department with severe sepsis/septic shock .

Criteria

Inclusion Criteria:

  • Patients greater than 18 years of age who present to the emergency department with the diagnosis of severe sepsis/septic shock.
  • This will include patients that have 2/4 SIRS criteria, a suspected infection and either a initial serum lactate >4mmol/L or a initial systolic blood pressure < 90mmHg.

Exclusion Criteria:

  • Patients in whom antibiotics have been administered >2 hours prior to assessment.
  • Patients with antibiotics in the community in the past 48 hours
  • Patients with known severe coagulopathy
  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: NCT01867905

Contacts
Contact: David Sweet, M.D. 604-875-4275 ddsweet@mail.ubc.ca
Contact: Matthew P Cheng, M.D.,C.M. 604-561-5301 matthew.cheng@mail.mcgill.ca

Locations
Canada, British Columbia
Lions Gate Hospital Recruiting
North Vancouver, British Columbia, Canada, V7L 2L7
Contact: Adam C Davidson, M.D.       adamcdavidson@gmail.com   
Contact: David Sweet, M.D.    604-875-4275    ddsweet@mail.ubc.ca   
Principal Investigator: Adam C Davidson, M.D.         
Sub-Investigator: David Sweet, M.D.         
Sub-Investigator: Matthew P Cheng, M.D.,C.M.         
Sub-Investigator: Matthew J Kadatz, M.D.         
Sub-Investigator: Mypinder Sekhon, M.D.         
Sub-Investigator: Patrick Doyle, M.D.         
Saint-Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Rob Stenstrom, M.D.       robstenstrom@shaw.ca   
Contact: David Sweet, M.D.    604-875-4275    ddsweet@mail.ubc.ca   
Principal Investigator: Rob Stenstrom, M.D.         
Sub-Investigator: David Sweet, M.D.         
Sub-Investigator: Matthew P Cheng, M.D.,C.M.         
Sub-Investigator: Matthew J Kadatz, M.D.         
Sub-Investigator: Mypinder Sekhon, M.D.         
Sub-Investigator: Patrick Doyle, M.D.         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: David Sweet, M.D.    604-875-4275    ddsweet@mail.ubc.ca   
Contact: Matthew P Cheng, M.D.,C.M.    604-561-5301    matthew.cheng@mail.mcgill.ca   
Principal Investigator: David Sweet, M.D.         
Sub-Investigator: Matthew P Cheng, M.D.,C.M.         
Sub-Investigator: Matthew J Kadatz, M.D.         
Sub-Investigator: Mypinder Sekhon, M.D.         
Sub-Investigator: Patrick Doyle, M.D.         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: David Sweet, M.D. University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01867905     History of Changes
Other Study ID Numbers: H12-01716, H12-01716
Study First Received: May 29, 2013
Last Updated: May 22, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Severe sepsis
Septic shock
Bacteremia
Antibiotics
Blood culture positivity

Additional relevant MeSH terms:
Shock, Septic
Bacteremia
Sepsis
Shock
Toxemia
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014