Plain English Summary
Background and study aims
This observational study aims to determine the capacity of baseline clinical and biological parameters and an associated prediction model (RAPID score) to predict mortality from pleural infection (infection of the membrane that enfolds the lungs).
Who can participate?
Patients diagnosed with a pleural infection will be invited to participate.
What does the study involve?
This study has been specifically designed to collect clinical and biological data - for example, the results of blood tests and pleural fluid analysis, and physical observations such as blood pressure, chest X-rays, chest ultrasound scans, lung function testing - in patients with diagnosed pleural infection. We hope that by analysing these results a diagnostic tool (or prediction score) can be developed that will help doctors in the future identify which patients with pleural infection are at higher or lower risk of serious problems or complications. This will hopefully help doctors choose the best treatment options for their patients.
What are the possible benefits and risks of participating?
We hope that every patient in the study will benefit, as normal, from the treatment they receive for their pleural infection as well as the opportunity for regular and continued follow-up appointments and assessments. Participation in the study will not however entitle patients to receive any specific or specialist treatment that they might not otherwise have access to. When the study is completed, we hope that the information collected from those individuals who choose to participate will help us to improve the treatment of patients with pleural infection in the future. Pleural infection itself and the different methods of treating it have their own associated risks and complications, but none of these are affected by participation in this study. Patients will have at least three chest x-rays during their participation, although many of these would need to be done whether you were in the study or not. There are some theoretical health risks from excessive radiation exposure, but chest x-rays are considered one of the safest tests as the dose from one is only equivalent to around four days' worth of normal background radiation.
Where is the study run from?
The study is being led and co-ordinated by the Oxford Respiratory Trials Unit based at the Churchill Hospital, Oxford, United Kingdom.
When is the study starting and how long is it expected to run for?
In total, 500/600 patients from hospitals around the world will participate in this study over an approximate three year period starting in 2013.
Who is funding the study?
Medical Research Council (UK).
Who is the main contact?
Mrs Emma Hedley
emma.hedley@ouh.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Najib Rahman
ORCID ID
Contact details
Oxford Respiratory Trials Unit
Oxford Centre for Respiratory Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
-
emma.hedley@ouh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.0 20/03/2013
Study information
Scientific title
The Pleural Infection Longitudinal Outcome Study: an observational cohort study
Acronym
PILOT
Study hypothesis
An observation study to ascertain the capacity of baseline clinical and biological parameters and an associated prediction model (RAPID score) to predict mortality from pleural infection at 3 months.
Ethics approval
NRES Committee South Central - Oxford B, 11/07/2013, REC ref: 13/SC/0204
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pleural Infection
Intervention
Demographics, details of clinical history and past medical history, drug history including antibiotic use within the last 4 weeks and baseline clinical observations, as recorded in normal clinical care. Baseline blood parameters (e.g. full blood count, inflammatory markers, renal function) and measurement of pleural fluid parameters (protein, glucose, LDH and pH if not purulent fluid, standard pleural fluid microbiology), chest X-ray and 10mL (0.3floz) of blood and 20mL (0.6floz) of pleural fluid will be obtained at enrolment into the study and stored in individual local centres.
Patients will be followed up at 3 and 12 months post trial entry.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The primary outcome of this study is the capability of the prediction score (RAPID) to predict mortality from pleural infection at 3 months.
The PILOT study is intended to ascertain the capacity of baseline clinical and biological parameters and an associated prediction model (RAPID score) to predict key clinical outcomes including mortality from pleural infection. These include renal indices, age, purulence of pleural fluid, infection source and albumin measured at baseline.
Secondary outcome measures
The secondary outcomes of this study are the capability of baseline clinical indices and the prediction score (RAPID) to predict the following:
1. Mortality from pleural infection at 12 months
2. Duration of hospital (in-patient) stay
3. Necessity for surgical fluid drainage over 12 months
4. Failure of medical treatment
5. Residual lung function impairment at 3 months
Overall trial start date
01/05/2013
Overall trial end date
31/10/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients, both male and female, aged 18 years or over with pleural infection as diagnosed by standard and internationally-accepted criteria as follows:
1. A clinical presentation compatible with pleural infection, AND
2. A pleural fluid collection that may or (rarely, according to clinical judgement) may not require drainage that meets at least one or more of the following criteria:
2.1. Purulent
2.2. Gram stain positive for bacteria
2.3. Bacterial culture positive
2.4. Acidic with a pH <7.2
2.5. Low pleural fluid glucose <3mmol/L (<40mg/dL)
2.6. CT evidence of pleural infection (consolidation of underlying lung with enhancing pleural collection on contrast-enhanced CT)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
550
Participant exclusion criteria
1. Age <18 years
2. No pleural fluid available for analysis
3. Previous pneumonectomy on the side of pleural infection
4. Expected survival <3 months due to co-morbid disease
5. Inability to give informed consent
Recruitment start date
01/05/2013
Recruitment end date
01/01/2017
Locations
Countries of recruitment
Australia, Belgium, Singapore, United Kingdom, United States of America
Trial participating centre
Oxford Respiratory Trials Unit
Oxford
OX3 7LE
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Oxford University Hospitals NHS Trust
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
-
ctrg@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list