Severe SepsisNCT01867905
Antibiotic Administration and Blood Culture Positivity in Severe Sepsis and Septic Shock
An observational study of Severe Sepsis and Septic Shock, run by University of British Columbia at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock, Bacteremia
- How many people
- 330 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Mar 2014to 10 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (age > 18) who present to the emergency department with severe sepsis/septic shock .
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada6 sites
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Lions Gate Hospital
North Vancouver, British Columbia, V7L 2L7
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Saint-Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
United States1 site
Maricopa Integrated Health Center
Phoenix, Arizona, 85008
About this study
Official title: The Effect of Antibiotic Administration on Blood Culture Positivity in Patients With Severe Sepsis and Septic Shock: a Prospective Multicenter Observational Trial.
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.
Read more
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.
- Conditions
- Severe Sepsis, Septic Shock, Bacteremia
- Keywords
- Severe sepsis, Septic shock, Bacteremia, Antibiotics, Blood culture positivity
- Medical subject headings
- Sepsis, Shock, Septic, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of antibiotic administration on blood culture positivity in patients with severe sepsis and septic shock: a prospective multicenter observational trial.
The primary outcome is the measure of blood culture positivity before and after antibiotic administration.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start1 Mar 2014
- Primary completion5 Sep 2018
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, University of Arizona
- Responsible party
- Principal investigator, Matthew Pellan Cheng, University of British Columbia
- Investigators
- David Sweet, M.D., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867905
- Sponsor's protocol ID
- H12-01716
- Other IDs
- H12-01716
- Status last verified
- Apr 2019
- First submitted
- 29 May 2013
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Paquette K, Sweet D, Stenstrom R, Stabler SN, Lawandi A, Akhter M, Davidson AC, Gavric M, Jinah R, Saeed Z, Demir K, Sangsari S, Huang K, Mahpour A, Shamatutu C, Caya C, Troquet JM, Clark G, Wong T, Yansouni CP, Cheng MP. Neither Blood Culture Positivity nor Time to Positivity Is Associated With Mortality Among Patients Presenting With Severe Manifestations of Sepsis: The FABLED Cohort Study. Open Forum Infect Dis. 2021 Jun 17;8(7):ofab321. doi: 10.1093/ofid/ofab321. eCollection 2021 Jul.
PubMed 34307728Cheng 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.
PubMed 31525774
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antibiotic Administration on Blood Culture Positivity in Patients With Severe Sepsis and Septic Shock: a Prospective Multicenter Observational Trial.
- ClinicalTrials.gov ID
- NCT01867905
- Acronym / sponsor ID
- H12-01716
- Conditions
- Severe Sepsis, Septic Shock, Bacteremia
- Keywords
- Severe sepsis, Septic shock, Bacteremia, Antibiotics, Blood culture positivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- McGill University, University of Arizona
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age > 18) who present to the emergency department with severe sepsis/septic shock .
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 34307728Paquette K, Sweet D, Stenstrom R, Stabler SN, Lawandi A, Akhter M, Davidson AC, Gavric M, Jinah R, Saeed Z, Demir K, Sangsari S, Huang K, Mahpour A, Shamatutu C, Caya C, Troquet JM, Clark G, Wong T, Yansouni CP, Cheng MP. Neither Blood Culture Positivity nor Time to Positivity Is Associated With Mortality Among Patients Presenting With Severe Manifestations of Sepsis: The FABLED Cohort Study. Open Forum Infect Dis. 2021 Jun 17;8(7):ofab321. doi: 10.1093/ofid/ofab321. eCollection 2021 Jul.
- Derived from this study: PubMed 31525774Cheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Sweet, M.D. principal investigator
University of British Columbia
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Septic Shock, run by University of British Columbia at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867905, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.