Bloodstream InfectionBLOOMY-COMNCT03578835
Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes
An observational study of Bloodstream Infection and Septic Shock, run by University Hospital Tuebingen at 6 sites in Germany.
Trial summary
Continual surveillance of both community-acquired and nosocomial bloodstream infections for specific target organisms. Analysis of comorbidities, complications, bacterial resistance patterns, bacterial genomics (e. g. via WGS and MLST typing) for the determinants of clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection, Septic Shock
- How many people
- 6,000 participants
- Where
- 6 sitesGermany
- Study dates
- 1 Feb 2017to 30 Jun 2019
- How long will I take part?
- 6 Months
- 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 inpatients with at least one blood culture positive for any of the target organisms: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa.
Who may be able to join
- At least 18 years old
- Informed consent given either by patient or guardian
- Inpatient
- At least one blood culture positive for one of the following bacteria: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa
Who cannot join
- Less than 18 years old
- Not capable of giving informed consent nor informed consent given by guardian
- Outpatient
- No blood cultures positive for any of the target organisms
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 12203
- Recruiting
Universitätskliniken Köln
Cologne, North Rhine-Westphalia, 50931
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
- Recruiting
Justus-Liebig-Universität Gießen
Giessen, Hesse, 35392
- Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
- Recruiting
Universitätsklinikum Tübingen
Tübingen, Bade-Württemberg, 72076
About this study
Continual surveillance of both community-acquired and nosocomial bloodstream infections for specific target organisms. Analysis of comorbidities, complications, bacterial resistance patterns, bacterial genomics (e. g. via WGS and MLST typing) for the determinants of clinical outcomes. The clinical outcomes are investigated both in the short-term (up until discharge) and the long-term (six months after index blood culture by standardized questionnaire). A predictive point-of-care score is to be developed based on these data to define high-risk patient populations requiring more intensive diagnostic and/or treatment regimens.
- Conditions
- Bloodstream Infection, Septic Shock
- Keywords
- BSI, SF-36, Clinical Outcome, Whole Genome Sequencing, Predictive Score, Bloodstream Infection, Septic Shock, Multi-resistant Bacteria
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-center BSI cohort | Patients from six German study centers suffering from bloodstream infection caused by specific target organisms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term mortality due to bloodstream infection
Mortality due to bloodstream infection up to hospital discharge in association to causative species, resistance pattern, comorbidities, complications etc.
Measured: From index blood culture to discharge, an average of 16 days
Long-term mortality due to bloodstream infection
Mortality due to bloodstream infection up to long-term follow-up after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.
Measured: Up to 6 months
Long-term morbidity due to bloodstream infection
Morbidity as measured by the SF-36 questionnaire due to bloodstream infection after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Feb 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- 6,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Freiburg, University Hospital Lübeck, University Hospital of Berlin, University of Giessen, Universitätsklinikum Köln
- Responsible party
- Principal investigator, Prof. Dr. Evelina Tacconelli, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578835
- Sponsor's protocol ID
- DZIF TTU 08.810
- Acronym
- BLOOMY-COM
- Status last verified
- Jul 2018
- First submitted
- 11 Apr 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03578835
- Acronym / sponsor ID
- BLOOMY-COM / DZIF TTU 08.810
- Conditions
- Bloodstream Infection, Septic Shock
- Keywords
- BSI, SF-36, Clinical Outcome, Whole Genome Sequencing, Predictive Score, Bloodstream Infection, Septic Shock, Multi-resistant Bacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Freiburg, University Hospital Lübeck, University Hospital of Berlin, University of Giessen, Universitätsklinikum Köln
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 6 Jul 2018 (actual)
- 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.
Continual surveillance of both community-acquired and nosocomial bloodstream infections for specific target organisms. Analysis of comorbidities, complications, bacterial resistance patterns, bacterial genomics (e. g. via WGS and MLST typing) for the determinants of clinical outcomes. The clinical outcomes are investigated both in the short-term (up until discharge) and the long-term (six months after index blood culture by standardized questionnaire). A predictive point-of-care score is to be developed based on these data to define high-risk patient populations requiring more intensive diagnostic and/or treatment regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-center BSI cohort | – | –Patients from six German study centers suffering from bloodstream infection caused by specific target organisms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients with at least one blood culture positive for any of the target organisms: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa.
Key inclusion criteria (4 listed)
- At least 18 years old
- Informed consent given either by patient or guardian
- Inpatient
- At least one blood culture positive for one of the following bacteria: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa
Key exclusion criteria (4 listed)
- Less than 18 years old
- Not capable of giving informed consent nor informed consent given by guardian
- Outpatient
- No blood cultures positive for any of the target organisms
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
Short-term mortality due to bloodstream infection
Time frame: From index blood culture to discharge, an average of 16 days
Mortality due to bloodstream infection up to hospital discharge in association to causative species, resistance pattern, comorbidities, complications etc.
Long-term mortality due to bloodstream infection
Time frame: Up to 6 months
Mortality due to bloodstream infection up to long-term follow-up after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.
Long-term morbidity due to bloodstream infection
Time frame: At 6 months
Morbidity as measured by the SF-36 questionnaire due to bloodstream infection after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection and Septic Shock, run by University Hospital Tuebingen at 6 sites 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 4 inclusion and 4 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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Evelina Tacconelli, Prof. (004970712983685, Evelina.Tacconelli@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term mortality due to bloodstream infection (time frame: From index blood culture to discharge, an average of 16 days). The study lists 3 primary outcomes in all. 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 6 Jul 2018.