ClinicalTrials.gov
ClinicalTrials.gov Menu

Pulmonary CT in Pneumonia Complicating Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03106909
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Natalie Garratt, Salford Royal NHS Foundation Trust

Brief 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. 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.


Condition or disease Intervention/treatment
Stroke Pneumonia Radiation: pulmonary computed tomography (CT)

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 Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans Pneumonia


Intervention Details:
  • Radiation: pulmonary computed tomography (CT)
    Pulmonary CT imaging


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatient stroke service at Salford Royal Foundation Trust (SRFT) and Royal Stoke University Hospital (RSUH)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106909


Contacts
Contact: CRAIG J SMITH 0161 206 5755 craig.smith-2@manchester.ac.uk
Contact: SHARON HULME 0161 206 5755 sharon.hulme@manchester.ac.uk

Locations
United Kingdom
Salford Royal Nhs Foundation Trust Recruiting
Salford, Greater Manchester, United Kingdom, M6 8HD
Contact: CRAIG SMITH    0161 206 0623    craig.smith-2@manchester.ac.uk   
Contact: SHARON HULME    0161 206 5755    sharon.hulme@manchester.ac.uk   
Royal Stoke University Hospital Recruiting
Stoke on Trent, Staffordshire, United Kingdom, ST4 6QG
Contact: CHRISTINE ROFFE    01782 672739    christine.roffe@uhnm.nhs.uk   
Contact: HOLLY MAGUIRE    01782 672739    holly.maguire@uhnm.nhs.uk   
Sponsors and Collaborators
Natalie Garratt
Investigators
Principal Investigator: CRAIG SMITH Salford Royal NHS Foundation Trust

Responsible Party: Natalie Garratt, Research & Development Lead, Salford Royal NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03106909     History of Changes
Other Study ID Numbers: 213436
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Natalie Garratt, Salford Royal NHS Foundation Trust:
stroke
pneumonia
biomarkers
pulmonary CT

Additional relevant MeSH terms:
Stroke
Pneumonia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections