Pleural InfectionAUDIONCT02608814
Advanced Ultrasound in Pleural Infection
A study testing Pleural biopsy sampling and Ultrasound in people with Pleural Infection, run by University of Oxford at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Infection
- What is being tested?
- Pleural biopsy sampling and Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2015to 14 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
North Bristol NHS Trust, Southmead Hospital
Bristol, BS10 5NB
Oxford Respiratory Trials Unit, Churchill Hospital
Oxford, OX3 7LE
About this study
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.
Read more
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.
- Conditions
- Pleural Infection
- Being tested
- Pleural biopsy sampling, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural biopsy samplingProcedure or surgery
6 - 8 pleural biopsy samples will be taken before the insertion of the chest drain. These samples will be sent to microbiology for examination.
UltrasoundOther
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase microbiological yield.
Measured: Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid.
Secondary outcomes (5)
Radiographic improvement in area of pleural collection measured by the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography.
Measured: Day 1 and Day 7
Mortality from pleural infection
Measured: 3 and 12 months
Duration of hospital (in patient) stay
Measured: From 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 completion
Measured: 3 and 12 months
Pleural fluid drainage over 7 days
Measured: First 7 days of trial involvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMay 2015
- Primary completion14 Mar 2017
- Study completion14 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural InfectionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608814
- Sponsor's protocol ID
- AUDIO
- Acronym
- AUDIO
- Status last verified
- May 2017
- First submitted
- 21 Oct 2015
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Ultrasound in Pleural Infection
- ClinicalTrials.gov ID
- NCT02608814
- Acronym / sponsor ID
- AUDIO / AUDIO
- Conditions
- Pleural Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 14 Mar 2017 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleural biopsy sampling6 - 8 pleural biopsy samples will be taken before the insertion of the chest drain. These samples will be sent to microbiology for examination. | Procedure or surgery | – |
| Ultrasound | Other | – |
Primary outcome
To increase microbiological yield.
Time frame: Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid.
5 secondary outcomes
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
Mortality from pleural infection
Time frame: 3 and 12 months
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.
Necessity for surgical fluid drainage documented in case report forms over study completion
Time frame: 3 and 12 months
Pleural fluid drainage over 7 days
Time frame: First 7 days of trial involvement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
Related trials for Pleural Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
RecruitingPhase 4
VATS or Intrapleural Enzymatic Therapy for Patients With Empyema.
Empyema, Pleural, Pleural Infections
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Not yet recruiting
Evaluating Antibiotic Course Upon Adequate Treatment of Empyema
Pleural Empyema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleural biopsy sampling and Ultrasound in people with Pleural Infection, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To increase microbiological yield. (time frame: Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.