StrokeNCT03106909
Pulmonary CT in Pneumonia Complicating Stroke
An observational study of Stroke and Pneumonia, run by Natalie Garratt at 2 sites in United Kingdom.
Trial summary
Pneumonia commonly complicates stroke and has a profound impact on clinical outcomes. Accurate and timely diagnosis of pneumonia complicating stroke remains a major challenge as several issues potentially confound diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- pulmonary computed tomography (CT)
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Apr 2017to 31 Jul 2018
- 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: Inpatient stroke service at Salford Royal Foundation Trust (SRFT) and Royal Stoke University Hospital (RSUH)
Who may be able to join
- Inpatient in SRFT or RSUH with diagnosis of stroke current admission
- Within 24h of clinically suspected pneumonia occurring after admission
- Aged ≥18y
- Provision of informed consent from participant or personal consultee
- Able to undergo pulmonary CT within next 48h
Who cannot join
- Treatment for lower respiratory tract infection (LRTI) completed within the preceding month
- Mechanical ventilation planned or anticipated imminently
- End-of-life care planned or anticipated imminently
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Salford Royal Nhs Foundation Trust
Salford, Greater Manchester, M6 8HD
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
Official title: Feasibility and Reliability of Pulmonary Computed Tomography as a Radiological Reference Standard for Evaluating Chest X-ray and Candidate Biomarkers in Suspected Pneumonia Complicating Stroke
Pneumonia commonly complicates stroke and has a profound impact on clinical outcomes. Accurate and timely diagnosis of pneumonia complicating stroke remains a major challenge as several issues potentially confound diagnosis. Chest X-ray (CXR), a central component in the diagnostic work-up, may have limited utility in the early stages as they are often of suboptimal quality, and infrequently confirm typical diagnostic infiltrates. Blood biomarkers of the stress-immune response have received considerable attention, but interpretation has been limited by differing methodologies, including definition of pneumonia. Bacterial organisms in the oral cavity may also be of relevance as biomarkers of post-stroke pneumonia. Major challenges facing frontline clinicians are therefore whether to initiate antibiotics; if so, when and for how long. These issues have antibiotic stewardship implications for clinicians in terms of potential for under-treatment or over-treatment with antibiotics based on CXR appearances.
Pulmonary Computed Tomography (CT) could be of value as a radiological reference standard when pneumonia is suspected after stroke, and enable more rigorous evaluation of the diagnostic performance of CXR (and other candidate biomarkers) to inform decision-making when pneumonia is suspected.
The overall primary aim is therefore to investigate the feasibility and reliability of using pulmonary CT as a radiological reference standard for evaluating suspected pneumonia complicating stroke. The secondary aims are to explore the diagnostic accuracy of CXR and blood biomarkers (index tests) when pneumonia is suspected during hospital admission after stroke using pulmonary CT as a reference standard.
Read the detailed description
Pneumonia is a frequent complication of stroke, particularly within the first few days. The risk of pneumonia is increased in patients who are older, have a more severe stroke and in those who have swallowing problems as a result of their stroke. Patients who develop pneumonia have a higher risk of death and longer hospital stay. The diagnosis of pneumonia is not always easy, but it is important to identify pneumonia early in order to begin the most appropriate treatment in a timely fashion and avoid giving antibiotics unnecessarily. Chest x-ray, the standard test undertaken when pneumonia is suspected, infrequently shows changes and is of limited value.
Pulmonary Computed Tomography (CT) scans can be used to image the lungs in more detail than a standard chest xray. The Investigators plan to assess if it is feasible to perform pulmonary CT imaging in stroke patients within 48 hours of symptoms and who may be acutely unwell. The Investigators will also investigate how reliable CT is at diagnosing pneumonia by asking different x-ray doctors to review the scans. Comparing the result of the pulmonary CT imaging to the chest x-ray will allow assessment of their utility for the diagnosis of pneumonia. The Investigators will also record whether the CT informs clinical management e.g. stopping antibiotics if pneumonia is excluded.
Blood samples will be collected for measurement of inflammatory markers and mouth swabs will measure types of bacteria. The analysis will be conducted at Salford Royal NHS Foundation Trust (SRFT) and using new cutting-edge techniques performed by collaborators at ThermoFisher and Manchester Collaborative Centre for Inflammation Research. The Investigators will assess how useful these inflammatory proteins are in pneumonia diagnosis compared to the pulmonary CT scans. This research will help the Investigating team design larger studies to diagnose pneumonia earlier and more accurately, enabling more effective use of antibiotics.
- Being tested
- pulmonary computed tomography (CT)
- Keywords
- stroke, pneumonia, biomarkers, pulmonary CT
- Medical subject headings
- Stroke, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary computed tomography (CT)Radiation
Pulmonary CT imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of eligible participants from screening; eligible participants declining participation (and reasons)
Measured: 18 months
Proportion of participants undergoing pulmonary CT
Participants scanned and reasons for not scanning
Measured: 18 months
Secondary outcomes (17)
Proportion of consenting participants undergoing repeat CXR when indicated
Measured: 18 months
Proportion with changes consistent with pneumonia on CXR; proportion with changes consistent with pneumonia on pulmonary CT
Measured: 18 months
Proportion participants with changes consistent with pneumonia on pulmonary CT
Measured: 18 months
Characteristics and distribution of radiological changes consistent with pneumonia on pulmonary CT
Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values
Measured: 18 months
Spectrum of additional radiological findings on pulmonary CT
Measured: 18 months
Inter-rater reliability of CXR; and pulmonary CT interpretation
Inter-rater reliability of the CXR reports will be evaluated using k statistics and the Bland and Altman method
Measured: 3 months
Inter-rater reliability of pulmonary CT interpretation
Inter-rater reliability of the pulmonary CT reports will be evaluated using k statistics and the Bland and Altman method
Measured: 3 months
Proportion of participants with confirmed pneumonia
Confirmed pneumonia is defined as meeting the PISCES clinical criteria AND with changes of pneumonia on pulmonary CT, agreed by an adjudication panel
Measured: 18 months
Estimate and confidence intervals of sensitivity and specificity of CXR
Using diagnostic odds ratio for CXR singly and with repeat CXR where indicated clinically
Measured: 3 months
Estimate and confidence intervals of sensitivity and specificity of C-reactive protein (CRP) markers
Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values
Measured: 18 months
Estimate and confidence intervals of sensitivity and specificity of procalcitonin (PCT)
Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values
Measured: 18 months
Estimate and confidence intervals of sensitivity and specificity of copeptin
Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values
Measured: 18 months
Estimate and confidence intervals of sensitivity and specificity of pro-adrenomedullin (Pro-ADM)
Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values
Measured: 18 months
Estimate and confidence intervals of sensitivity and specificity of monocyte/ B-cell markers
Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values
Measured: 18 months
Characteristics of oral bacterial species
Oral bacterial species will be compared in patients with and without confirmed pneumonia in univariate hypothesis generating analyses
Measured: 18 months
Distribution of oral bacterial species
Oral bacterial species will be compared in patients with and without confirmed pneumonia in univariate hypothesis generating analyses
Measured: 18 months
Number of days of antibiotic treatment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start10 Apr 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natalie Garratt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Natalie Garratt, Northern Care Alliance NHS Foundation Trust
- Investigators
- CRAIG SMITH, Principal investigator, Northern Care Alliance NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106909
- Sponsor's protocol ID
- 213436
- Status last verified
- Feb 2020
- First submitted
- 1 Feb 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Reliability of Pulmonary Computed Tomography as a Radiological Reference Standard for Evaluating Chest X-ray and Candidate Biomarkers in Suspected Pneumonia Complicating Stroke
- ClinicalTrials.gov ID
- NCT03106909
- Acronym / sponsor ID
- 213436
- Keywords
- stroke, pneumonia, biomarkers, pulmonary CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Natalie GarrattUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 11 Apr 2017 (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.
Pneumonia commonly complicates stroke and has a profound impact on clinical outcomes. Accurate and timely diagnosis of pneumonia complicating stroke remains a major challenge as several issues potentially confound diagnosis. Chest X-ray (CXR), a central component in the diagnostic work-up, may have limited utility in the early stages as they are often of suboptimal quality, and infrequently confirm typical diagnostic infiltrates. Blood biomarkers of the stress-immune response have received considerable attention, but interpretation has been limited by differing methodologies, including definition of pneumonia. Bacterial organisms in the oral cavity may also be of relevance as biomarkers of post-stroke pneumonia. Major challenges facing frontline clinicians are therefore whether to initiate antibiotics; if so, when and for how long. These issues have antibiotic stewardship implications for clinicians in terms of potential for under-treatment or over-treatment with antibiotics based on CXR appearances.
Pulmonary Computed Tomography (CT) could be of value as a radiological reference standard when pneumonia is suspected after stroke, and enable more rigorous evaluation of the diagnostic performance of CXR (and other candidate biomarkers) to inform decision-making when pneumonia is suspected.
The overall primary aim is therefore to investigate the feasibility and reliability of using pulmonary CT as a radiological reference standard for evaluating suspected pneumonia complicating stroke. The secondary aims are to explore the diagnostic accuracy of CXR and blood biomarkers (index tests) when pneumonia is suspected during hospital admission after stroke using pulmonary CT as a reference standard.
Detailed description
Pneumonia is a frequent complication of stroke, particularly within the first few days. The risk of pneumonia is increased in patients who are older, have a more severe stroke and in those who have swallowing problems as a result of their stroke. Patients who develop pneumonia have a higher risk of death and longer hospital stay. The diagnosis of pneumonia is not always easy, but it is important to identify pneumonia early in order to begin the most appropriate treatment in a timely fashion and avoid giving antibiotics unnecessarily. Chest x-ray, the standard test undertaken when pneumonia is suspected, infrequently shows changes and is of limited value.
Pulmonary Computed Tomography (CT) scans can be used to image the lungs in more detail than a standard chest xray. The Investigators plan to assess if it is feasible to perform pulmonary CT imaging in stroke patients within 48 hours of symptoms and who may be acutely unwell. The Investigators will also investigate how reliable CT is at diagnosing pneumonia by asking different x-ray doctors to review the scans. Comparing the result of the pulmonary CT imaging to the chest x-ray will allow assessment of their utility for the diagnosis of pneumonia. The Investigators will also record whether the CT informs clinical management e.g. stopping antibiotics if pneumonia is excluded.
Blood samples will be collected for measurement of inflammatory markers and mouth swabs will measure types of bacteria. The analysis will be conducted at Salford Royal NHS Foundation Trust (SRFT) and using new cutting-edge techniques performed by collaborators at ThermoFisher and Manchester Collaborative Centre for Inflammation Research. The Investigators will assess how useful these inflammatory proteins are in pneumonia diagnosis compared to the pulmonary CT scans. This research will help the Investigating team design larger studies to diagnose pneumonia earlier and more accurately, enabling more effective use of antibiotics.
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
- Inpatient stroke service at Salford Royal Foundation Trust (SRFT) and Royal Stoke University Hospital (RSUH)
Key inclusion criteria (5 listed)
- Inpatient in SRFT or RSUH with diagnosis of stroke current admission
- Within 24h of clinically suspected pneumonia occurring after admission
- Aged ≥18y
- Provision of informed consent from participant or personal consultee
- Able to undergo pulmonary CT within next 48h
Key exclusion criteria (3 listed)
- Treatment for lower respiratory tract infection (LRTI) completed within the preceding month
- Mechanical ventilation planned or anticipated imminently
- End-of-life care planned or anticipated imminently
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 |
|---|---|---|
| pulmonary computed tomography (CT)Pulmonary CT imaging | Radiation | – |
Primary outcome
Proportions of eligible participants from screening; eligible participants declining participation (and reasons)
Time frame: 18 months
Proportion of participants undergoing pulmonary CT
Time frame: 18 months
Participants scanned and reasons for not scanning
17 secondary outcomes
Proportion of consenting participants undergoing repeat CXR when indicated
Time frame: 18 months
Proportion with changes consistent with pneumonia on CXR; proportion with changes consistent with pneumonia on pulmonary CT
Time frame: 18 months
Proportion participants with changes consistent with pneumonia on pulmonary CT
Time frame: 18 months
Characteristics and distribution of radiological changes consistent with pneumonia on pulmonary CT
Time frame: 18 months
Spectrum of additional radiological findings on pulmonary CT
Time frame: 18 months
Inter-rater reliability of CXR; and pulmonary CT interpretation
Time frame: 3 months
Inter-rater reliability of pulmonary CT interpretation
Time frame: 3 months
Proportion of participants with confirmed pneumonia
Time frame: 18 months
Estimate and confidence intervals of sensitivity and specificity of CXR
Time frame: 3 months
Estimate and confidence intervals of sensitivity and specificity of C-reactive protein (CRP) markers
Time frame: 18 months
Estimate and confidence intervals of sensitivity and specificity of procalcitonin (PCT)
Time frame: 18 months
Estimate and confidence intervals of sensitivity and specificity of copeptin
Time frame: 18 months
Estimate and confidence intervals of sensitivity and specificity of pro-adrenomedullin (Pro-ADM)
Time frame: 18 months
Estimate and confidence intervals of sensitivity and specificity of monocyte/ B-cell markers
Time frame: 18 months
Characteristics of oral bacterial species
Time frame: 18 months
Distribution of oral bacterial species
Time frame: 18 months
Number of days of antibiotic treatment
Time frame: 18 months
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 7 Feb 2020.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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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.
CRAIG SMITH principal investigator
Northern Care Alliance NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Pneumonia, run by Natalie Garratt at 2 sites in United Kingdom.
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 5 inclusion and 3 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Proportions of eligible participants from screening; eligible participants declining participation (and reasons) (time frame: 18 months). 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?
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 7 Feb 2020.