Skip to main content
OpenTrials
Completed

NCT Number: NCT03106909

Pulmonary CT in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infections Lung Diseases Nervous System Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Salford Royal Nhs Foundation Trust, Salford, Greater Manchester, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmonary computed tomography (CT)

Radiation

Pulmonary CT imaging

Primary outcomes

  1. Proportions of eligible participants from screening; eligible participants declining participation (and reasons)

    Time frame: 18 months

  2. Proportion of participants undergoing pulmonary CT

    Time frame: 18 months

    Participants scanned and reasons for not scanning

Secondary outcomes

  1. Proportion of consenting participants undergoing repeat CXR when indicated

    Time frame: 18 months

  2. Proportion with changes consistent with pneumonia on CXR; proportion with changes consistent with pneumonia on pulmonary CT

    Time frame: 18 months

  3. Proportion participants with changes consistent with pneumonia on pulmonary CT

    Time frame: 18 months

  4. Characteristics and distribution of radiological changes consistent with pneumonia on pulmonary CT

    Time frame: 18 months

    Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values

  5. Spectrum of additional radiological findings on pulmonary CT

    Time frame: 18 months

  6. Inter-rater reliability of CXR; and pulmonary CT interpretation

    Time frame: 3 months

    Inter-rater reliability of the CXR reports will be evaluated using k statistics and the Bland and Altman method

  7. Inter-rater reliability of pulmonary CT interpretation

    Time frame: 3 months

    Inter-rater reliability of the pulmonary CT reports will be evaluated using k statistics and the Bland and Altman method

  8. Proportion of participants with confirmed pneumonia

    Time frame: 18 months

    Confirmed pneumonia is defined as meeting the PISCES clinical criteria AND with changes of pneumonia on pulmonary CT, agreed by an adjudication panel

  9. Estimate and confidence intervals of sensitivity and specificity of CXR

    Time frame: 3 months

    Using diagnostic odds ratio for CXR singly and with repeat CXR where indicated clinically

  10. Estimate and confidence intervals of sensitivity and specificity of C-reactive protein (CRP) markers

    Time frame: 18 months

    Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values

  11. Estimate and confidence intervals of sensitivity and specificity of procalcitonin (PCT)

    Time frame: 18 months

    Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values

  12. Estimate and confidence intervals of sensitivity and specificity of copeptin

    Time frame: 18 months

    Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values

  13. Estimate and confidence intervals of sensitivity and specificity of pro-adrenomedullin (Pro-ADM)

    Time frame: 18 months

    Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values

  14. Estimate and confidence intervals of sensitivity and specificity of monocyte/ B-cell markers

    Time frame: 18 months

    Using standard assessments of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values

  15. Characteristics of oral bacterial species

    Time frame: 18 months

    Oral bacterial species will be compared in patients with and without confirmed pneumonia in univariate hypothesis generating analyses

  16. Distribution of oral bacterial species

    Time frame: 18 months

    Oral bacterial species will be compared in patients with and without confirmed pneumonia in univariate hypothesis generating analyses

  17. Number of days of antibiotic treatment

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Natalie Garratt

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2017
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.