An observational study in Stroke, Acute and Pneumonia, Bacterial, sponsored by Jakob Ström. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Jakob Ström · Observational
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.
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 200 is close to the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →This is the only study on the registry with Jakob Ström as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients with severe (defined as NIHSS score of \> 10) acute stroke, either ischemic or hemorrhagic. (n= 150)
Patients with moderately severe (defined as NIHSS score of \> 5 but \< 11) acute stroke, either ischemic or hemorrhagic. (n= 25)
Patients with mild (defined as NIHSS score of \<6) acute stroke, either ischemic or hemorrhagic. (n= 25)
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).
Time frame: 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.
Time frame: The day before pneumonia onset.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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