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Advanced Ultrasound in Pleural Infection (AUDIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608814
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease Intervention/treatment Phase
Pleural Infection Procedure: Pleural biopsy sampling Other: Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Primary Purpose: Basic Science
Official Title: Advanced Ultrasound in Pleural Infection
Study Start Date : May 2015
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : March 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • 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


Primary Outcome Measures :
  1. To increase microbiological yield. [ Time Frame: Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid. ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608814


Locations
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United Kingdom
North Bristol NHS Trust, Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Oxford Respiratory Trials Unit, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02608814    
Other Study ID Numbers: AUDIO
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Infection
Communicable Diseases