Condition category
Respiratory
Date applied
20/03/2013
Date assigned
20/05/2013
Last edited
26/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

01/01/2017

Reason abandoned

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

http://www.ox.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes