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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12621001230842
Ethics application status
Approved
Date submitted
5/07/2021
Date registered
13/09/2021
Date last updated
12/01/2022
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Parapneumonic effusion and empyema: aetiology and clinical outcome evaluation in Canterbury. The PEACE study.
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Scientific title
Parapneumonic effusion and empyema: current aetiology, new biomarkers and clinical outcome evaluation in Canterbury. The PEACE study. A prospective cohort study in adults with pleural infections.
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Secondary ID [1]
304695
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None
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Universal Trial Number (UTN)
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Trial acronym
PEACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parapneumonic effusion
322679
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Empyema
322680
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Pleural infection
322681
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Condition category
Condition code
Respiratory
320293
320293
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0
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Other respiratory disorders / diseases
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Infection
320639
320639
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0
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Other infectious diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This single centre prospective cohort study aims to assess the current aetiology, patients’ characteristics, complications, (new) biomarkers, clinical outcome, and quality of life in patients with parapneumonic effusion or empyema.
All adult patients admitted to the respiratory medicine ward at Christchurch Hospital with empyema or parapneumonic effusion and who meet all inclusion and no exclusion criteria will be invited to participate. Participants will be recruited between August 2021 and August 2023, with a longitudinal follow-up for 1 year.
The majority of data will be obtained through standard care, using the Canterbury Hospital HealthPathway of ‘Pleural Effusion’. Data will be collected from the patient’s electronic hospital file and the patient during admission, with the use of a patient questionnaire.
During the study, we will take additional blood and pleural fluid samples. Samples will be taken only once, at baseline, during hospital admission.
The quality of life and symptom measurements are additional as well to the standard care. The patient will be asked to complete questionnaires on quality of life and symptoms on admission, at discharge, and during follow-up after discharge (1, 6, and 12 months). During follow-up, based on individual preferences, the participant will be sent the questionnaires by mail with a return envelope or by email via Qualtrics.
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Intervention code [1]
321071
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Diagnosis / Prognosis
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
328148
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Current aetiology of parapneumonic effusion and empyema in Canterbury based on conventional culture of pleural fluid
(composite primary outcome)
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Assessment method [1]
328148
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Timepoint [1]
328148
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T1. Baseline - hospital admission: samples for pleural fluid culture will be taken during standard diagnostic care in participants with a clinical suspicion of a pleural infection.
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Primary outcome [2]
328150
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Current aetiology of parapneumonic effusion and empyema in Canterbury, based on additional nucleic acid amplification tests (NAAT) on pleural fluid
(composite primary outcome)
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Assessment method [2]
328150
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Timepoint [2]
328150
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T1. Baseline - hospital admission: samples for NAAT will be taken during standard diagnostic care in participants with a clinical suspicion of a pleural infection. NAAT analyses will be done in batches.
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Primary outcome [3]
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Exploratory evaluation of pleural fluid inflammatory response markers and pleural injury markers, and neutrophil function and activity on their role in classification and prognostication in empyema and parapneumonic effusion (composite outcome).
Eg. myeloperoxidase, procalcitonin, proADM
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Assessment method [3]
328895
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Timepoint [3]
328895
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T1. Baseline - hospital admission: pleural fluid samples taken at baseline
Analyses will be done in batches
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Secondary outcome [1]
399058
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Added diagnostic yield of NAAT in comparison to conventional culture, determined by the improvement of microbiological yield based on the specificity of NAAT compared to conventional culture
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Assessment method [1]
399058
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Timepoint [1]
399058
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Based on the samples taken at T1. Baseline - hospital admission: samples for pleural fluid culture and NAAT will be taken during standard diagnostic care in participants with a clinical suspicion of a pleural infection.
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Secondary outcome [2]
399059
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Exploratory evaluation of blood biomarkers (inflammatory response markers and pleural injury markers, and neutrophil function and activity) in classifying and prognostication in empyema and parapneumonic effusion. (composite, primary outcome)
Eg. myeloperoxidase, procalcitonin, proADM
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Assessment method [2]
399059
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Timepoint [2]
399059
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T1. Baseline - hospital admission: blood samples taken at baseline
Analyses will be done in batches
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Secondary outcome [3]
399060
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Recovery of symptoms, assessing thoracic pain with the use of the Visual Analog Scale (VAS)
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Assessment method [3]
399060
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Timepoint [3]
399060
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T1. Baseline - hospital admission - 2 questionnaires, symptoms at admission and before admission (-30days, based on recall)
T2. At discharge
T3. 1 month after discharge
T4. 6 months after discharge
T5. 12 months after discharge
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Secondary outcome [4]
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Quality of life during and after admission, assessed by the short Form-36 Health Survey questionnaire
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Assessment method [4]
399061
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Timepoint [4]
399061
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T1. Baseline - hospital admission
T2. At discharge
T3. 1 month after discharge
T4. 6 months after discharge
T5. 12 months after discharge
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Secondary outcome [5]
399892
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Current aetiology of parapneumonic effusion in Canterbury based on conventional culture of pleural fluid
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Assessment method [5]
399892
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Timepoint [5]
399892
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T1. Baseline - hospital admission: samples for pleural fluid culture will be taken during standard diagnostic care in participants with a clinical suspicion of a pleural infection.
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Secondary outcome [6]
399893
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Current aetiology of empyema in Canterbury based on conventional culture of pleural fluid
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Assessment method [6]
399893
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Timepoint [6]
399893
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T1. Baseline - hospital admission: samples for pleural fluid culture will be taken during standard diagnostic care in participants with a clinical suspicion of a pleural infection.
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Secondary outcome [7]
399896
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Health outcomes of patients with empyema and parapneumonic in Canterbury, assessed by re-admission rate (within 30 days after discharge), determined by review of medical records
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Assessment method [7]
399896
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Timepoint [7]
399896
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T3. 1 month after discharge
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Secondary outcome [8]
399897
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Health outcomes of patients with empyema and parapneumonic in Canterbury, assessed by
mortality rate (30-day and 12 months), determined by review of medical records
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Assessment method [8]
399897
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Timepoint [8]
399897
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T2. At discharge
T3. 1 month after discharge
T4. 6 months after discharge
T5. 12 months after discharge
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Secondary outcome [9]
399898
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Health outcomes of patients with empyema and parapneumonic in Canterbury, assessed by
complications during admission (i.e. bronchopleural fistulae, ICU admission, invasive ventilation) determined by review of medical records
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Assessment method [9]
399898
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Timepoint [9]
399898
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T2. At discharge
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Secondary outcome [10]
399899
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Health outcomes of patients with empyema and parapneumonic in Canterbury, assessed by
radiographic outcomes, resolution of abnormalities, determined by review of medical records
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Assessment method [10]
399899
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Timepoint [10]
399899
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T1. Baseline - hospital admission
T2. At discharge
T3. 1 month after discharge
T4. 6 months after discharge
T5. 12 months after discharge
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Secondary outcome [11]
399900
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Recovery of symptoms, assessing dyspnoea with the modified Medical Research Council (mMRC) breathlessness scale)
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Assessment method [11]
399900
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Timepoint [11]
399900
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T1. Baseline - hospital admission - 2 questionnaires, symptoms at admission and before admission (-30days, based on recall)
T2. At discharge
T3. 1 month after discharge
T4. 6 months after discharge
T5. 12 months after discharge
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Secondary outcome [12]
399901
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Recovery of symptoms, assessed by the community-acquired pneumonia symptom questionnaire (CAP-sym)
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Assessment method [12]
399901
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Timepoint [12]
399901
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T1. Baseline - hospital admission - 2 questionnaires, symptoms at admission and before admission (-30days, based on recall)
T2. At discharge
T3. 1 month after discharge
T4. 6 months after discharge
T5. 12 months after discharge
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Secondary outcome [13]
400821
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Health outcomes of patients with empyema and parapneumonic in Canterbury, assessed by length of hospital stay (in days), determined by review of medical records
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Assessment method [13]
400821
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Timepoint [13]
400821
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T1. Baseline - hospital admission
T2. At discharge
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Eligibility
Key inclusion criteria
- Age > 18 years
- Clinical suspicion of parapneumonic effusion (simple and complicated) or empyema.
- Clinically indication pleural aspiration or drainage
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Earlier enrolment to the study
- Not able to provide informed consent
- Treatment failure or complication from recent medical intervention (e.g. pleural drainage, VATS)
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Baseline characteristics and aetiology:
For demographic and clinical variables at baseline, data will be presented as median (IQR) or means (SD) for continuous variables and number (%) for categorical variables.
Regarding aetiology results, we will use the nomenclature and classification used by our microbiology department. Furthermore, we will also group the results into binary test results (positive vs negative culture) and calculate the sensitivity. In case of additional enhanced diagnostic testing through nuclear acid amplification tests, we will assess the added value of these tests to standard culture by calculating the improved sensitivity for detecting causative pathogens.
Biomarkers:
The ability of the different biomarkers (pleural fluid and blood) to accurately differentiate between empyema, simple and complicated parapneumonic effusion, clinical management, and clinical outcomes will be studied with the use of receiver-operating characteristics (ROC) analyses. The ROC curves will be used to demonstrate the decision values of various cut-off points for the different biomarkers. Univariate logistic regression will be performed to test the association for each biomarker with the presence of empyema, complicated parapneumonic effusion (CPPE), or simple parapneumonic effusion (SPPE). Significant predictors from these analyses will be used for a multivariate logistic regression analysis to assess the independent predictive value. A p-value of <0.05 will be considered statistically significant.
Clinical outcomes:
We will use univariate and multivariate logistic regression analyses to identify independent predictors of the different aspects of patients’ outcomes.
The change from baseline to 12 months in the quality of life and symptom measurements will be calculated by analysis of covariance (ANCOVA) adjusted for the baseline measurements. To compare the proportion of patients (empyema vs CPPE vs SPPE) with either clinical or quality-of-life improvement, stability, or decline, a binomial test will be performed and presented differences as a percentage with accompanying 95% CI. Categorical data between groups will be calculated with the chi-square test. P- values of <0.05 will be significant.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
15/09/2021
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Actual
9/11/2021
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Date of last participant enrolment
Anticipated
15/09/2023
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Actual
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Date of last data collection
Anticipated
24/09/2024
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Actual
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Sample size
Target
150
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Accrual to date
4
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Final
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Recruitment outside Australia
Country [1]
23941
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New Zealand
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State/province [1]
23941
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Canterbury
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Funding & Sponsors
Funding source category [1]
309062
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Charities/Societies/Foundations
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Name [1]
309062
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W.H. Travis Trust
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Address [1]
309062
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C/o Ashton Wheelans & Hegan Limited 4th Floor, 127 Armagh Street Christchurch
Christchurch 9999
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Country [1]
309062
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New Zealand
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Primary sponsor type
University
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Name
University of Otago, Christchurch
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Address
2 Riccarton Avenue, Christchurch Central City, Christchurch 8011
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Country
New Zealand
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Secondary sponsor category [1]
310011
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None
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Name [1]
310011
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Address [1]
310011
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Country [1]
310011
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308940
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Northern A Health and Disability Ethics Committee
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Ethics committee address [1]
308940
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Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
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Ethics committee country [1]
308940
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New Zealand
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Date submitted for ethics approval [1]
308940
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24/02/2021
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Approval date [1]
308940
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28/06/2021
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Ethics approval number [1]
308940
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21/NTA/35
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Summary
Brief summary
Pleural effusion is a build-up of fluid in the pleural space, the thin space between the lungs and the inner surface of the chest wall. Normally, there is a small amount of fluid in this space. However, due to many different reasons, the fluid in the pleural space can accumulate. Among these causes are pleural infectious effusions, specifically
(simple and complicated) parapneumonic effusion and empyema.
Parapneumonic effusions and empyema are increasing in incidence and associated with high morbidity and mortality. Empyema carries a case-fatality ratio of up to 20% overall and up to 42% in patients with significant comorbidities, such as lung cancer.
This prospective cohort study aims to assess the current aetiology, patients’ characteristics, new biomarkers, clinical outcomes, and quality of life in patients with parapneumonic effusion or empyema. To be able to better understand the opportunities for improving diagnostics and outcomes in future patients with empyema and parapneumonic pleural effusion.
In addition, we aim to establish a biobank for future unspecified research of participant data and samples enrolled in the PEACE study.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Margot (J.M.) de Koning Gans
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Address
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University of Otago, Christchurch
Department of Medicine
2 Riccarton Avenue, Christchurch Central City, Christchurch 8011
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Country
112402
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New Zealand
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Phone
112402
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+64 3 364 1116
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Fax
112402
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Email
112402
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[email protected]
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Contact person for public queries
Name
112403
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Dr Margot (J.M.) de Koning Gans
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Address
112403
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University of Otago, Christchurch
Department of Medicine
2 Riccarton Avenue, Christchurch Central City, Christchurch 8011
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Country
112403
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New Zealand
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Phone
112403
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+64 3 364 1116
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Fax
112403
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Email
112403
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[email protected]
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Contact person for scientific queries
Name
112404
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Dr Margot (J.M.) de Koning Gans
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Address
112404
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University of Otago, Christchurch
Department of Medicine
2 Riccarton Avenue, Christchurch Central City, Christchurch 8011
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Country
112404
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New Zealand
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Phone
112404
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+64 3 364 1116
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Fax
112404
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Email
112404
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Only de-identified data collected during the PEACE study of participants who consented to participate in the Biobank as well will be available. No tissue samples will be available.
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When will data be available (start and end dates)?
Beginning 3 months following main results publication from the PEACE study. No end date determined.
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Available to whom?
This future research will need to be approved by an appropriate ethical review committee and our research team.
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Available for what types of analyses?
All types of analyses that are approved by an appropriate ethical review committee and our research team.
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How or where can data be obtained?
By contacting the principal investigator via e-mail:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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