Advanced Ultrasound in Pleural Infection | NCT02608814

Studies
Advanced Ultrasound in Pleural Infection

NCT02608814

Sponsor

University of Oxford

Status

Completed

Last Update Posted

May 16, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Pleural Infection

Interventions

Pleural biopsy sampling
Ultrasound

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Mar 14, 2017Actual

Completion Date

Mar 14, 2017Actual

First Submitted Date

Oct 21, 2015

First Submission Date that Met QC Criteria

Nov 16, 2015

First Posted Date

Nov 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2017

Last Update Posted Date

May 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Bristol NHS Trust, Southmead Hospital		Bristol		BS10 5NB	United Kingdom
Oxford Respiratory Trials Unit, Churchill Hospital

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

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