Sepsis Septic ShockBEMIDIANCT03000049
Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study
An observational study of Sepsis Septic Shock, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
With a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System) it is possible to optimize the initial antimicrobial therapy in patients with sepsis and septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis Septic Shock
- What is being tested?
- bedside blood culture
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Sep 2017
- 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: Patients with sepsis or septic shock with planned blood culture drawing
Who may be able to join
- Patients with a new diagnosed sepsis or septic shock: emergency department, operating theatre, intensive care unit and planed blood culture diagnostics.
- informed written consent
Who cannot join
- Pediatric patients (< 18 Years)
- DNR-order
Trial locations and contacts
1 site in 1 country.
Matthias Gründling, MD contact
Germany1 site, 1 recruiting
- Recruiting
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Greifswald, 17475
Sven-Olaf Kuhn, MD, 3834507952, kuhn@uni-greifswald.de
Matthias Gründling, MD
About this study
With a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System) it is possible to optimize the initial antimicrobial therapy in patients with sepsis and septic shock.
Prospective observational, open-label mono-center study to compare a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients with sepsis or septic shock.
- Conditions
- Sepsis Septic Shock
- Being tested
- bedside blood culture
- Keywords
- sepsis, septic shock, blood cultures, anti-infective therapy
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bedside blood cultureOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock
Measured: Nov. 2016 - Nov. 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis Septic ShockStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven-Olaf Kuhn, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000049
- Sponsor's protocol ID
- SD_BK_1_ANI
- Acronym
- BEMIDIA
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study
- ClinicalTrials.gov ID
- NCT03000049
- Acronym / sponsor ID
- BEMIDIA / SD_BK_1_ANI
- Conditions
- Sepsis Septic Shock
- Keywords
- sepsis, septic shock, blood cultures, anti-infective therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 21 Dec 2016 (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.
With a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System) it is possible to optimize the initial antimicrobial therapy in patients with sepsis and septic shock.
Prospective observational, open-label mono-center study to compare a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients with sepsis or septic shock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis or septic shock with planned blood culture drawing
Key inclusion criteria (2 listed)
- Patients with a new diagnosed sepsis or septic shock: emergency department, operating theatre, intensive care unit and planed blood culture diagnostics.
- informed written consent
Key exclusion criteria (2 listed)
- Pediatric patients (< 18 Years)
- DNR-order
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bedside blood culture | Other | – |
Primary outcome
Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock
Time frame: Nov. 2016 - Nov. 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Matthias Gründling, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Septic Shock, run by University Medicine Greifswald at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Gründling, MD (gruendli@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock (time frame: Nov. 2016 - Nov. 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2016.