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Advanced Ultrasound in Pleural Infection

Advanced Ultrasound in Pleural Infection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02608814
Acronym
AUDIO
Enrollment
20
Registered
2015-11-20
Start date
2015-05-31
Completion date
2017-03-14
Last updated
2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Infection

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.

Interventions

PROCEDUREPleural biopsy sampling

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

OTHERUltrasound

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
To increase microbiological yield.Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid.

Secondary

MeasureTime 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 infection3 and 12 months
Duration of hospital (in patient) stayFrom 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 completion3 and 12 months
Pleural fluid drainage over 7 daysFirst 7 days of trial involvement

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026