Advanced Ultrasound in Pleural Infection (AUDIO)

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.

Study Overview

• Status: Completed
• Conditions: Pleural Infection
• Intervention / Treatment: Procedure: Pleural biopsy sampling; Other: Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • North Bristol NHS Trust, Southmead Hospital
  • Oxford, United Kingdom, OX3 7LE
    • Oxford Respiratory Trials Unit, Churchill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To increase microbiological yield.	Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid.

Secondary Outcome Measures

Outcome Measure	Time Frame
Radiographic improvement in area of pleural collection measured by the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography.	Day 1 and Day 7
Mortality from pleural infection	3 and 12 months
Duration of hospital (in patient) stay	From the date of initial hospital admission to the date of discharge assessed up to 2 weeks.
Necessity for surgical fluid drainage documented in case report forms over study completion	3 and 12 months
Pleural fluid drainage over 7 days	First 7 days of trial involvement

Collaborators and Investigators

• Sponsor: University of Oxford

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 14, 2017
• Study Completion (Actual): March 14, 2017

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: AUDIO