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Advanced Ultrasound in Pleural Infection (AUDIO)

Primary Purpose

Pleural Infection

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pleural biopsy sampling
Ultrasound
Sponsored by
University of Oxford
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pleural Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A clinical presentation compatible with pleural infection
  • 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:
  • Purulent
  • Gram stain positive for bacteria
  • Bacterial culture positive
  • Acidic with a pH <7.2
  • Low pleural fluid glucose <3mmol/L (<55mg/dL)
  • CT evidence of pleural infection (consolidation of underlying lung with enhancing pleural collection on contrast-enhanced CT)

Exclusion Criteria:

  • Age <18 years
  • No pleural fluid available for analysis
  • Previous pneumonectomy on the side of pleural infection
  • Expected survival <3 months due to co-morbid disease
  • Inability to give informed consent.

Sites / Locations

  • North Bristol NHS Trust, Southmead Hospital
  • Oxford Respiratory Trials Unit, Churchill Hospital

Outcomes

Primary Outcome Measures

To increase microbiological yield.

Secondary Outcome Measures

Radiographic improvement in area of pleural collection measured by the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography.
Mortality from pleural infection
Duration of hospital (in patient) stay
Necessity for surgical fluid drainage documented in case report forms over study completion
Pleural fluid drainage over 7 days

Full Information

First Posted
October 21, 2015
Last Updated
May 15, 2017
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT02608814
Brief Title
Advanced Ultrasound in Pleural Infection
Acronym
AUDIO
Official Title
Advanced Ultrasound in Pleural Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
March 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pleural infection is a potentially serious infection of the fluid normally found around the lung and current evidence suggests its incidence is increasing in both adult and paediatric populations. Identification of bacterial pathogens causing pleural infection is of paramount importance in the clinical care of patients are currently, only 40% of patients have a laboratory confirmed microbiological diagnosis for their pleural infection. An unclear diagnosis can be due to various reasons such as a small sample volume therefore the aim of the AUDIO study is to ascertain the capacity of pleural biopsies in improving the microbiological yield of pleural infection. Currently, there are no well validated methods for identifying patients presenting with pleural infection on the basis of initial ultrasound imaging. The AUDIO study will define the role of baseline thoracic ultrasound in predicting the radiographic, clinical and surgical outcomes of patients with pleural infection. The AUDIO study aims to recruit 50 patients from 2 centres with specific pleural expertise and these patients will be followed up over a 12 month period. Investigators hope that through the information gathered from ultrasound imaging and pleural biopsies, it will aid physicians' clinical and therapeutic decision making when treating patients with pleural infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Infection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Pleural biopsy sampling
Intervention Description
6 - 8 pleural biopsy samples will be taken before the insertion of the chest drain. These samples will be sent to microbiology for examination.
Intervention Type
Other
Intervention Name(s)
Ultrasound
Primary Outcome Measure Information:
Title
To increase microbiological yield.
Time Frame
Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid.
Secondary Outcome Measure Information:
Title
Radiographic improvement in area of pleural collection measured by the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography.
Time Frame
Day 1 and Day 7
Title
Mortality from pleural infection
Time Frame
3 and 12 months
Title
Duration of hospital (in patient) stay
Time Frame
From the date of initial hospital admission to the date of discharge assessed up to 2 weeks.
Title
Necessity for surgical fluid drainage documented in case report forms over study completion
Time Frame
3 and 12 months
Title
Pleural fluid drainage over 7 days
Time Frame
First 7 days of trial involvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A clinical presentation compatible with pleural infection 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: Purulent Gram stain positive for bacteria Bacterial culture positive Acidic with a pH <7.2 Low pleural fluid glucose <3mmol/L (<55mg/dL) CT evidence of pleural infection (consolidation of underlying lung with enhancing pleural collection on contrast-enhanced CT) Exclusion Criteria: Age <18 years No pleural fluid available for analysis Previous pneumonectomy on the side of pleural infection Expected survival <3 months due to co-morbid disease Inability to give informed consent.
Facility Information:
Facility Name
North Bristol NHS Trust, Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Oxford Respiratory Trials Unit, Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom

12. IPD Sharing Statement

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Advanced Ultrasound in Pleural Infection

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