Stroke Clinical Trial
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
NCT number | NCT03106909 |
Other study ID # | 213436 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 10, 2017 |
Est. completion date | July 31, 2018 |
Verified date | February 2020 |
Source | Salford Royal NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Salford Royal Nhs Foundation Trust | Salford | Greater Manchester |
United Kingdom | Royal Stoke University Hospital | Stoke on Trent | Staffordshire |
Lead Sponsor | Collaborator |
---|---|
Natalie Garratt |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportions of eligible participants from screening; eligible participants declining participation (and reasons) | 18 months | ||
Primary | Proportion of participants undergoing pulmonary CT | Participants scanned and reasons for not scanning | 18 months | |
Secondary | Proportion of consenting participants undergoing repeat CXR when indicated | 18 months | ||
Secondary | Proportion with changes consistent with pneumonia on CXR; proportion with changes consistent with pneumonia on pulmonary CT | 18 months | ||
Secondary | Proportion participants with changes consistent with pneumonia on pulmonary CT | 18 months | ||
Secondary | 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 | 18 months | |
Secondary | Spectrum of additional radiological findings on pulmonary CT | 18 months | ||
Secondary | 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 | 3 months | |
Secondary | 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 | 3 months | |
Secondary | 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 | 18 months | |
Secondary | Estimate and confidence intervals of sensitivity and specificity of CXR | Using diagnostic odds ratio for CXR singly and with repeat CXR where indicated clinically | 3 months | |
Secondary | 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 | 18 months | |
Secondary | 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 | 18 months | |
Secondary | Estimate and confidence intervals of sensitivity and specificity of copeptin | Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values | 18 months | |
Secondary | 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 | 18 months | |
Secondary | 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 | 18 months | |
Secondary | Characteristics of oral bacterial species | Oral bacterial species will be compared in patients with and without confirmed pneumonia in univariate hypothesis generating analyses | 18 months | |
Secondary | Distribution of oral bacterial species | Oral bacterial species will be compared in patients with and without confirmed pneumonia in univariate hypothesis generating analyses | 18 months | |
Secondary | Number of days of antibiotic treatment | 18 months |
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