Stroke, AcuteIBISNCT03812666
Search for Biomarkers of Infection and Inflammation in Patients With Acute Stroke.
An observational study of Stroke, Acute and Pneumonia, Bacterial, run by Jakob Ström at 1 site in Sweden.
Trial summary
This study will look for new biomarkers of infection and evaluate current biomarkers of infection in stroke patients. Patients with acute stroke will be monitored with daily blood samples for seven days and by clinical examination to detect infections for 10 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Pneumonia, Bacterial
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2019to 1 Jul 2025
- 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: Eligible patients admitted to Örebro University hospital will be consecutively offered enrollement. The sample is weighted to include more patients with severe stroke (defined as NIHSS ≥ 11) than with moderate (NIHSS ≤10 and ≥ 6) or mild (NIHSS ≤5) stroke. The purpose of this is to ensure that a high proportion of participants will contract pneumonia since patients with a more severe stroke have a higher risk of pneumonia.
Who may be able to join
- Symptoms and radiology consistent with acute cerebral infarction or atraumatic intracerebral hemorrhage.
- National Institutes of Health Stroke Scale (NIHSS) ≤5; mild stroke (n=25), NIHSS ≤10 and ≥ 6; moderate stroke (n=25) or NIHSS ≥ 11; severe stroke (n=150)
- Onset of symptoms less than 48 hours before first study blood sampling.
Who cannot join
- Symptoms and radiology consistent with acute cerebral infarction but full reversal of symptoms within 24 hours of onset. (i.e. transient ischemic attack, TIA)
- Hemoglobin less than 90 g/l.
- Ongoing inflammatory disease, such as rheumatoid arthritis or active inflammatory bowel disease.
- Inability to undergo MRI scan (only patients with NIHSS ≤10 will be excluded by this criteria)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Biomarkers In Stroke - Discovery Phase
This study will look for new biomarkers of infection and evaluate current biomarkers of infection in stroke patients. Patients with acute stroke will be monitored with daily blood samples for seven days and by clinical examination to detect infections for 10 days.
Read the detailed description
Rationale: Stroke is one of the leading causes of death globally, and infections after stroke contribute to a large part of the stroke-related mortality. The current study, which has a prospective, observational design, constitutes the second phase out of four in the Inflammatory Biomarkers In Stroke (IBIS) project, of which the overall goal is to enable early treatment of post-stroke infections.
Aim: To develop a combined clinical and molecular biological signature for early detection of pneumonia in patients with stroke.
Design: Prospective nested case control study
Methods:Patients (n=200) with acute stroke will be monitored with clinical examinations for ten days and by daily blood samples for seven days. When cases of pneumonia have been established, samples and examination results from days preceding overt pneumonia will be compared to samples from similar patients that did not develop pneumonia.
Outcome: Using proteomic and metabolomic methods, novel markers of upcoming pneumonia after stroke will be sought. Such laboratory markers will be combined with current biomarkers (such as C-reactive protein and procalcitonin) and data from clinical examinations, with the aim of constructing a biological signature that enables early detection of pneumonia.
- Conditions
- Stroke, Acute, Pneumonia, Bacterial
- Keywords
- Stroke, Pneumonia, Biomarkers, Infection
- Medical subject headings
- Stroke, Pneumonia, Bacterial, Pneumonia, Infections
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 stroke | Patients with severe (defined as NIHSS score of > 10) acute stroke, either ischemic or hemorrhagic. (n= 150) | |
| Moderately stroke | Patients with moderately severe (defined as NIHSS score of > 5 but < 11) acute stroke, either ischemic or hemorrhagic. (n= 25) | |
| Mild stroke | Patients with mild (defined as NIHSS score of <6) acute stroke, either ischemic or hemorrhagic. (n= 25) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel biomarkers of pneumonia
The study will analyze a broad expanse of potential biomarkers, including known markers of infection such as c-reactive protein, procalcitonin and increased respiratory frequency as well as novel markers that will be pursued using proteomic and metabolomic methods. Those that are significantly associated with upcoming pneumonia will be selected. Biomarkers will be evaluated by the area under the curve for the receiver operating characteristic (AUC-ROC).
Measured: The day before pneumonia onset.
A combined clinical and molecular biological signature for early detection of pneumonia
By combining novel (found using proteomic and metabolomic methods) and current biomarkers (such as c-reactive protein, procalcitonin and increased respiratory frequency) with data from clinical examinations, a biological signature that enables early detection of pneumonia will be constructed.
Measured: The day before pneumonia onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start15 Jan 2019
- Primary completion1 Jul 2023
- Study completion1 Jul 2025 (estimated)
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 Stroke, AcuteStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jakob Ström
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden
- Responsible party
- Sponsor-investigator, Jakob Ström, Region Örebro County
- Investigators
- Jakob Ström, MD, PhD, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812666
- Sponsor's protocol ID
- 247991
- Other IDs
- 2018/288
- Acronym
- IBIS
- Status last verified
- Nov 2023
- First submitted
- 16 Jan 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sjolin K, Royter B, Forgo B, Aulin J, Kultima K, Lindback J, Strom JO, Burman J. Plasma Profile of Brain-Derived Tau After Ischemic Stroke. Eur J Neurol. 2026 Aug;33(8):e70735. doi: 10.1111/ene.70735.
PubMed 42615578Sjolin K, Royter B, Forgo B, Aulin J, Kultima K, Lindback J, Strom JO, Burman J. Plasma Profiles of Neuroglial Injury Biomarkers after Ischemic Stroke. Transl Stroke Res. 2025 Dec;16(6):2185-2194. doi: 10.1007/s12975-025-01380-y. Epub 2025 Sep 3.
PubMed 40900222
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Biomarkers In Stroke - Discovery Phase
- ClinicalTrials.gov ID
- NCT03812666
- Acronym / sponsor ID
- IBIS / 247991
- Conditions
- Stroke, Acute, Pneumonia, Bacterial
- Keywords
- Stroke, Pneumonia, Biomarkers, Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jakob StrömUniversity, hospital or other
- Collaborators
- Örebro University, Sweden
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 23 Jan 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 study will look for new biomarkers of infection and evaluate current biomarkers of infection in stroke patients. Patients with acute stroke will be monitored with daily blood samples for seven days and by clinical examination to detect infections for 10 days.
Detailed description
Rationale: Stroke is one of the leading causes of death globally, and infections after stroke contribute to a large part of the stroke-related mortality. The current study, which has a prospective, observational design, constitutes the second phase out of four in the Inflammatory Biomarkers In Stroke (IBIS) project, of which the overall goal is to enable early treatment of post-stroke infections.
Aim: To develop a combined clinical and molecular biological signature for early detection of pneumonia in patients with stroke.
Design: Prospective nested case control study
Methods:Patients (n=200) with acute stroke will be monitored with clinical examinations for ten days and by daily blood samples for seven days. When cases of pneumonia have been established, samples and examination results from days preceding overt pneumonia will be compared to samples from similar patients that did not develop pneumonia.
Outcome: Using proteomic and metabolomic methods, novel markers of upcoming pneumonia after stroke will be sought. Such laboratory markers will be combined with current biomarkers (such as C-reactive protein and procalcitonin) and data from clinical examinations, with the aim of constructing a biological signature that enables early detection of pneumonia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe stroke | – | –Patients with severe (defined as NIHSS score of > 10) acute stroke, either ischemic or hemorrhagic. (n= 150) |
| Moderately stroke | – | –Patients with moderately severe (defined as NIHSS score of > 5 but < 11) acute stroke, either ischemic or hemorrhagic. (n= 25) |
| Mild stroke | – | –Patients with mild (defined as NIHSS score of <6) acute stroke, either ischemic or hemorrhagic. (n= 25) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients admitted to Örebro University hospital will be consecutively offered enrollement. The sample is weighted to include more patients with severe stroke (defined as NIHSS ≥ 11) than with moderate (NIHSS ≤10 and ≥ 6) or mild (NIHSS ≤5) stroke. The purpose of this is to ensure that a high proportion of participants will contract pneumonia since patients with a more severe stroke have a higher risk of pneumonia.
Key inclusion criteria (3 listed)
- Symptoms and radiology consistent with acute cerebral infarction or atraumatic intracerebral hemorrhage.
- National Institutes of Health Stroke Scale (NIHSS) ≤5; mild stroke (n=25), NIHSS ≤10 and ≥ 6; moderate stroke (n=25) or NIHSS ≥ 11; severe stroke (n=150)
- Onset of symptoms less than 48 hours before first study blood sampling.
Key exclusion criteria (4 listed)
- Symptoms and radiology consistent with acute cerebral infarction but full reversal of symptoms within 24 hours of onset. (i.e. transient ischemic attack, TIA)
- Hemoglobin less than 90 g/l.
- Ongoing inflammatory disease, such as rheumatoid arthritis or active inflammatory bowel disease.
- Inability to undergo MRI scan (only patients with NIHSS ≤10 will be excluded by this criteria)
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
Novel biomarkers of pneumonia
Time frame: The day before pneumonia onset.
The study will analyze a broad expanse of potential biomarkers, including known markers of infection such as c-reactive protein, procalcitonin and increased respiratory frequency as well as novel markers that will be pursued using proteomic and metabolomic methods. Those that are significantly associated with upcoming pneumonia will be selected. Biomarkers will be evaluated by the area under the curve for the receiver operating characteristic (AUC-ROC).
A combined clinical and molecular biological signature for early detection of pneumonia
Time frame: The day before pneumonia onset.
By combining novel (found using proteomic and metabolomic methods) and current biomarkers (such as c-reactive protein, procalcitonin and increased respiratory frequency) with data from clinical examinations, a biological signature that enables early detection of pneumonia will be constructed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 42615578Sjolin K, Royter B, Forgo B, Aulin J, Kultima K, Lindback J, Strom JO, Burman J. Plasma Profile of Brain-Derived Tau After Ischemic Stroke. Eur J Neurol. 2026 Aug;33(8):e70735. doi: 10.1111/ene.70735.
- Derived from this study: PubMed 40900222Sjolin K, Royter B, Forgo B, Aulin J, Kultima K, Lindback J, Strom JO, Burman J. Plasma Profiles of Neuroglial Injury Biomarkers after Ischemic Stroke. Transl Stroke Res. 2025 Dec;16(6):2185-2194. doi: 10.1007/s12975-025-01380-y. Epub 2025 Sep 3.
- Individual participant dataSharing planned: Undecided
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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.
Jakob Ström, MD, PhD principal investigator
Region Örebro County
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 Stroke, Acute and Pneumonia, Bacterial, run by Jakob Ström at 1 site in Sweden.
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 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 18 Nov 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 Sweden. 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?
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?
Novel biomarkers of pneumonia (time frame: The day before pneumonia onset.). The study lists 2 primary outcomes in all. 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 NCT03812666, 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 18 Nov 2023.