Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000814774
Ethics application status
Approved
Date submitted
21/07/2013
Date registered
24/07/2013
Date last updated
31/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical features, patterns of care and outcome of children with empyema: A retrospective review at a Regional Tropical Hospital
Scientific title
Retrospective cohort study of children with pleural empyema in a Regional Tropical Hospital, assessing their clinical features, patterns of care and clinical outcomes.
Secondary ID [1] 282874 0
None
Universal Trial Number (UTN)
U1111-1145-8683
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Empyema thoracis 289692 0
Acute pneumonia 289711 0
Condition category
Condition code
Respiratory 290012 290012 0 0
Other respiratory disorders / diseases
Infection 290032 290032 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessing those that have been treated with early thoracotomy versus those that have had either fibrinolytic or video-assisted thoracotomies, or just simple drainage and antibiotics. The duration of observation is the total admission for each individual episode of pneumonia and pleural empyema.
Intervention code [1] 287576 0
Not applicable
Comparator / control treatment
Controls are the reported standards of care from the national Thoracic Society, which do not advocate for early thoracotomy. The options for treatment in the controls are early thoractomy, fibrinolytic therapy, video-assisted thoracotomy, or simple drainage and antibiotics. Some may receive a combination of these. In Townsville, the standard is early open thoracotomy for reasons discussed in the paper. The source and period of the control data are the published reports from the Thoracic Society of Australia and New Zealand, with a paper by the Empyema Network in 2011 reporting on their recent experiences, and a position statement also from 2011.
Control group
Active

Outcomes
Primary outcome [1] 290058 0
Length of hospital stay.
Timepoint [1] 290058 0
Hospital admission duration
Secondary outcome [1] 303848 0
Complications from procedure/s. These can include failure of alternate therapy, such as simple drainage or fibroinolysis. Each comes with separate risks, such as haemorrhage (in some rare cases fatal) from fibrinolysis and chronic pain syndromes from thoracotomies.
These are assessed from the recorded entries in the case notes.
Timepoint [1] 303848 0
Measured over hospital admission duration and follow-up clinics.
Secondary outcome [2] 303849 0
Antibiotic selection strategy. This outcome is assessed by comparing the antibiotics charted on admission to the organism sensitivities derived from culture, when available, and ultimately successful antibiotic selection, if different.
Timepoint [2] 303849 0
Measured over duration of entire illness with data from referring hospital.

Eligibility
Key inclusion criteria
All children admitted to our tertiary referral centre in North Queensland, Australia with pleural effusion in the context of acute pneumonia.
Minimum age
0 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All adult cases.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The National society quotes an incidence of 0.7% of all pneumonias, based on data compiled from metropolitan areas. We are seeing empyema much more commonly in this in our children with pneumonia, presumably due to duration of illness prior to admission and alternate microbiological causes. We have seen 45 cases in 3 years present and be managed with a strategy different to the guidelines, and we will compare our results with a time matched cohort from other centres.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2013
Actual
3/03/2014
Date of last participant enrolment
Anticipated
28/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1350 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 7185 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 287659 0
Hospital
Name [1] 287659 0
The Townsville Hospital
Institute of Women's and Child Health
Department of Paediatrics
Country [1] 287659 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital, Institute of Women's and Child Health, Department of Paediatrics
Address
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country
Australia
Secondary sponsor category [1] 286397 0
None
Name [1] 286397 0
Address [1] 286397 0
Country [1] 286397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289622 0
Townsville Hospital Health Service Human Research Ethics Committee
Ethics committee address [1] 289622 0
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Ethics committee country [1] 289622 0
Australia
Date submitted for ethics approval [1] 289622 0
19/07/2013
Approval date [1] 289622 0
12/08/2013
Ethics approval number [1] 289622 0
HREC/13/QTHS/134

Summary
Brief summary
Pneumonia, an infection of the lung, is a common reason for admission to hospital, and worldwide is still the leading cause of mortality in children under 5 years. Relatively rarely, a complication of this is infected fluid surrounding the lung, termed an empyema. Empyemas are very rare in metropolitan areas, but anecdotally are more common in rural and remote regions. This is currently unreported. This audit will help us to find out exactly how many children are at risk, and which mode of management appears to confer the shortest hospital stay and with minimal complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41578 0
Dr Nathan Smalley
Address 41578 0
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 41578 0
Australia
Phone 41578 0
+61744331111
Fax 41578 0
Email 41578 0
nathan_smalley@health.qld.gov.au
Contact person for public queries
Name 41579 0
Nathan Smalley
Address 41579 0
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 41579 0
Australia
Phone 41579 0
+61744331111
Fax 41579 0
Email 41579 0
nathan_smalley@health.qld.gov.au
Contact person for scientific queries
Name 41580 0
Nathan Smalley
Address 41580 0
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 41580 0
Australia
Phone 41580 0
+61744331111
Fax 41580 0
Email 41580 0
nathan_smalley@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.