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

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.
 
ClinicalTrials.gov Identifier: NCT01867905
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
McGill University
University of Arizona
Information provided by (Responsible Party):
Matthew Pellan Cheng, University of British Columbia

Tracking Information
First Submitted Date May 29, 2013
First Posted Date June 4, 2013
Last Update Posted Date April 16, 2019
Actual Study Start Date March 1, 2014
Actual Primary Completion Date September 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2013)
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 ]
The primary outcome is the measure of blood culture positivity before and after antibiotic administration.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antibiotic Administration and Blood Culture Positivity in Severe Sepsis and Septic Shock
Official Title The Effect of Antibiotic Administration on Blood Culture Positivity in Patients With Severe Sepsis and Septic Shock: a Prospective Multicenter Observational Trial.
Brief Summary

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), Lion's Gate Hospital (LGH), Surrey Memorial Hospital, Montreal General Hospital (MGH), Royal Victoria Hospital (RVH) and Maricopa Integrated Health System. 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood cultures
Sampling Method Non-Probability Sample
Study Population Adult patients (age > 18) who present to the emergency department with severe sepsis/septic shock .
Condition
  • Severe Sepsis
  • Septic Shock
  • Bacteremia
Intervention Not Provided
Study 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.
Publications * Cheng MP, Stenstrom R, Paquette K, Stabler SN, Akhter M, Davidson AC, Gavric M, Lawandi A, Jinah R, Saeed Z, Demir K, Huang K, Mahpour A, Shamatutu C, Caya C, Troquet JM, Clark G, Yansouni CP, Sweet D; FABLED Investigators. Blood Culture Results Before and After Antimicrobial Administration in Patients With Severe Manifestations of Sepsis: A Diagnostic Study. Ann Intern Med. 2019 Oct 15;171(8):547-554. doi: 10.7326/M19-1696. Epub 2019 Sep 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 17, 2018)
330
Original Estimated Enrollment
 (submitted: June 3, 2013)
361
Actual Study Completion Date April 10, 2019
Actual Primary Completion Date September 5, 2018   (Final data collection date for primary outcome measure)
Eligibility 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 systemic inflammatory response syndrome criteria, a suspected infection and either a initial serum lactate > 4mmol/L or a initial systolic blood pressure < 90 millimeters of mercury.

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01867905
Other Study ID Numbers H12-01716
H12-01716
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Matthew Pellan Cheng, University of British Columbia
Study Sponsor University of British Columbia
Collaborators
  • McGill University
  • University of Arizona
Investigators
Principal Investigator: David Sweet, M.D. University of British Columbia
PRS Account University of British Columbia
Verification Date April 2019