Advanced Ultrasound in Pleural Infection

Pleural Infection Clinical Trial

— AUDIO  

Official title:

Advanced Ultrasound in Pleural Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608814
• Other study ID #: AUDIO
• Status: Completed
• Phase: N/A
• First received: October 21, 2015
• Last updated: May 15, 2017
• Start date: May 2015
• Est. completion date: March 14, 2017

Study information

• Verified date: May 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 14, 2017
• Est. primary completion date: March 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pleural Infection

Intervention

Procedure:
• Pleural 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.

Other:
• Ultrasound

Locations

Country	Name	City	State
United Kingdom	North Bristol NHS Trust, Southmead Hospital	Bristol
United Kingdom	Oxford Respiratory Trials Unit, Churchill Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To increase microbiological yield.		Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid.
Secondary	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
Secondary	Mortality from pleural infection		3 and 12 months
Secondary	Duration of hospital (in patient) stay		From the date of initial hospital admission to the date of discharge assessed up to 2 weeks.
Secondary	Necessity for surgical fluid drainage documented in case report forms over study completion		3 and 12 months
Secondary	Pleural fluid drainage over 7 days		First 7 days of trial involvement