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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
Patient registry
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

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.

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
All adult cases.

Study design
Natural history
Defined population
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Name [1] 287659 0
The Townsville Hospital
Institute of Women's and Child Health
Department of Paediatrics
Address [1] 287659 0
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country [1] 287659 0
Primary sponsor type
The Townsville Hospital, Institute of Women's and Child Health, Department of Paediatrics
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Secondary sponsor category [1] 286397 0
Name [1] 286397 0
Address [1] 286397 0
Country [1] 286397 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 289622 0
Approval date [1] 289622 0
Ethics approval number [1] 289622 0

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

Principal investigator
Name 41578 0
Dr Nathan Smalley
Address 41578 0
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 41578 0
Phone 41578 0
Fax 41578 0
Email 41578 0
Contact person for public queries
Name 41579 0
Dr Nathan Smalley
Address 41579 0
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 41579 0
Phone 41579 0
Fax 41579 0
Email 41579 0
Contact person for scientific queries
Name 41580 0
Dr Nathan Smalley
Address 41580 0
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 41580 0
Phone 41580 0
Fax 41580 0
Email 41580 0

No information has been provided regarding IPD availability
Summary results
No Results