Skip to main content
OpenTrials
Completed

NCT Number: NCT02608814

Advanced Ultrasound in Pleural Infection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pleural Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Bristol NHS Trust, Southmead Hospital, Bristol, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pleural biopsy sampling

Procedure

6 - 8 pleural biopsy samples will be taken before the insertion of the chest drain. These samples will be sent to microbiology for examination.

ultrasound

Other

Primary outcomes

  1. To increase microbiological yield.

    Time frame: Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid.

Secondary outcomes

  1. 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

  2. Mortality from pleural infection

    Time frame: 3 and 12 months

  3. 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.

  4. Necessity for surgical fluid drainage documented in case report forms over study completion

    Time frame: 3 and 12 months

  5. Pleural fluid drainage over 7 days

    Time frame: First 7 days of trial involvement

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Acronym: AUDIO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2015
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.