BacteremiaVit B12NCT04008446
Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients
An observational study of Bacteremia, run by University of Zurich at 1 site in Switzerland.
Trial summary
This is an prospective observational study assessing the effect of vitamin B12 on the odds of developing sepsis in patients with infection confirmed by a positive culture result. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2019to 31 Dec 2022
- 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 who present to the ED with suspicion of infection, and for whom microbiological cultures are indicated,can to be enrolled into the study
Who may be able to join
- Adults (≥18 years old)
- Infection, confirmed by a positive culture result
- Signed informed consent.
Who cannot join
- Pregnancy and/or breast feeding
- Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients : an Observational Study.
This is an prospective observational study assessing the effect of vitamin B12 on the odds of developing sepsis in patients with infection confirmed by a positive culture result.
The hypothesis is that patients with infection confirmed by positive cultures who develop sepsis have lower vitamin B12 levels than patients infection, confirmed by positive cultures, who do not develop sepsis.
- Conditions
- Bacteremia
- Medical subject headings
- Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Holotranscobalamin (HTC) levels
HTC levels in patients with infection and sepsis compared to patients with infection without sepsis.
Measured: 6 days
Secondary outcomes (2)
Vitamin B12 levels
Levels of vitamin B12 in patients with infection and sepsis compared to patients with infection without sepsis
Measured: 6 days
Methylmalonic acid (MMA) levels
Levels of ethylmalonic acid (MMA) in patients with infection and sepsis compared to patients with infection without sepsis
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Jun 2019
- Primary completion11 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008446
- Sponsor's protocol ID
- 2019-00702
- Other IDs
- 2019
- Acronym
- Vit B12
- Status last verified
- Jan 2023
- First submitted
- 17 Jun 2019
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pregernig A, Held U, Schlapfer M, Beck-Schimmer B. Vitamin B12 status and the risk of developing sepsis in patients with bacterial infection: a prospective observational cohort study. BMC Med. 2024 Aug 13;22(1):330. doi: 10.1186/s12916-024-03552-3.
PubMed 39134986
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients : an Observational Study.
- ClinicalTrials.gov ID
- NCT04008446
- Acronym / sponsor ID
- Vit B12 / 2019-00702
- Conditions
- Bacteremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jul 2019 (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.
This is an prospective observational study assessing the effect of vitamin B12 on the odds of developing sepsis in patients with infection confirmed by a positive culture result.
The hypothesis is that patients with infection confirmed by positive cultures who develop sepsis have lower vitamin B12 levels than patients infection, confirmed by positive cultures, who do not develop sepsis.
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 who present to the ED with suspicion of infection, and for whom microbiological cultures are indicated,can to be enrolled into the study
Key inclusion criteria (3 listed)
- Adults (≥18 years old)
- Infection, confirmed by a positive culture result
- Signed informed consent.
Key exclusion criteria (2 listed)
- Pregnancy and/or breast feeding
- Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia
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
Holotranscobalamin (HTC) levels
Time frame: 6 days
HTC levels in patients with infection and sepsis compared to patients with infection without sepsis.
2 secondary outcomes
Vitamin B12 levels
Time frame: 6 days
Methylmalonic acid (MMA) levels
Time frame: 6 days
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 10 Jan 2023.
- Derived from this study: PubMed 39134986Pregernig A, Held U, Schlapfer M, Beck-Schimmer B. Vitamin B12 status and the risk of developing sepsis in patients with bacterial infection: a prospective observational cohort study. BMC Med. 2024 Aug 13;22(1):330. doi: 10.1186/s12916-024-03552-3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bacteremia, run by University of Zurich at 1 site in Switzerland.
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 3 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: finished, as of the sponsor's last update on 10 Jan 2023. 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 Switzerland. 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?
Holotranscobalamin (HTC) levels (time frame: 6 days). 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 NCT04008446, which also lists 1 linked publication.
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 10 Jan 2023.