Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000476437
Ethics application status
Approved
Date submitted
23/08/2007
Date registered
21/09/2007
Date last updated
20/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Empyema in Children.
To obtain an accurate assessment of the disease burden among children with parapneumonic effusions and empyema associated with S.pneumoniae. There is potential to affect the national vaccination program if the project highlights that there is a large proportion of types of Streptococcus causing disease in children not covered by the current vaccine.
Scientific title
Prospective Study of Enhanced National Surveillance for Pneumococcal Empyema Thoracis in Children in Australia and New Zealand
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Empyema 2274 0
Streptococcus pneumoniae 2275 0
Condition category
Condition code
Infection 2365 2365 0 0
Studies of infection and infectious agents
Respiratory 2366 2366 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To obtain an accurate assessment of the disease burden among children with parapneumonic effusions and empyema associated with S.pneumoniae, the aim is to enrol children with parapneumonic effusions or empyema over a twenty four month period from all children presenting to paediatric hospitals throughout Australia and to Auckland, New Zealand. Clinical data on demographics, vaccination status, presentation, management and outcome will be obtained. Pleural effusions and empyema fluid specimens will be cultured, and analysis will be performed to describe the distribution of hospitalized children with culture-positive and culture-negative parapneumonic effusions and empyema. Children with culture-negative pneumococcal polymerase chain reaction (PCR)-positive effusions and empyema will be described by month of discharge, age, sex, underlying medical conditions as well as signs and symptoms of pneumonia. Pleural fluid will be tested for the presence of S.pneumoniae deoxyribonucleic acid (DNA) and, if positive, further tested to identify the pneumococcal serotype.
Intervention code [1] 1985 0
Not applicable
Comparator / control treatment
N/A
Control group
Active

Outcomes
Primary outcome [1] 3263 0
Identify the bacterial causes of empyema, including description and distribution of strains causing pneumococcal empyema
Timepoint [1] 3263 0
At the completion of the observational study (24 months)
Secondary outcome [1] 5445 0
To determine incidence and prevelance of empyema, describing epidemiology, clinical features and current management
Timepoint [1] 5445 0
At the completion of the observational study (24 months)

Eligibility
Key inclusion criteria
Children whose clinical condition necessitates drainage of pleural fluid secondary to pneumonia, and who present with the classical features of empyema; fever, cough, raised white cell count, raised C-reactive protein (CRP) and fluid present on ultrasound.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those over the age of 16yrs old, and those who do not present to a paediatric hospital

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/04/2007
Actual
27/04/2007
Date of last participant enrolment
Anticipated
Actual
12/03/2009
Date of last data collection
Anticipated
Actual
12/03/2009
Sample size
Target
200
Accrual to date
Final
173
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 564 0
New Zealand
State/province [1] 564 0

Funding & Sponsors
Funding source category [1] 2522 0
Commercial sector/Industry
Name [1] 2522 0
GlaxoSmith Kline Biologicals
Country [1] 2522 0
Belgium
Primary sponsor type
Individual
Name
A/Prof Adam Jaffe (Principle Investigator)
Address
Sydney Children's Hospital
High Street, Randwick 2031
NSW
Country
Australia
Secondary sponsor category [1] 2284 0
None
Name [1] 2284 0
.
Address [1] 2284 0
.
Country [1] 2284 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4439 0
South Eastern Sydney and Illawarra Area Health Service HREC - Northern Sector
Ethics committee address [1] 4439 0
Ethics committee country [1] 4439 0
Date submitted for ethics approval [1] 4439 0
01/01/2007
Approval date [1] 4439 0
27/02/2007
Ethics approval number [1] 4439 0
EC00134

Summary
Brief summary
Empyema is the accumulation of infective fluid around the lung and occurs in about 1 percent of pneumonias in children. The bacterium Streptococcus pneumoniae is a leading cause of empyema. There has been a national vaccination program in Australia for the past 5 years which covers 7 types of Streptococcus. There is evidence in other countries that a type called Serotype 1 is emerging and this is not covered by the vaccine in this country. There is also evidence that following the introduction of the vaccine in other countries there has been a rise in the number of empyemas in children. The aim of this project is to accurately assess the types of Streptococcus causing empyemas in children in Australia using molecular techniques which can increase our identification of the bacteria causing empyema greater than our current standard techniques.
The significance of the project is that it has the potential to affect the national vaccination program. If the project highlights that there is a large proportion of types of Streptococcus causing disease in children not covered by the current vaccine, then it may influence the Department of Health and Ageing in changing to another vaccine with a broader coverage. In addition, it is not known how best to manage children with empyemas and we will get data from different sites on how they are treating these children. We aim to develop a position paper for the Australian Paediatric Respiratory Group on managing children with this disease in Australia.
Trial website
Trial related presentations / publications
Presentations

Strachan RE, Gilbert GL, Cornelius A et al. Pleural Fluid Nucleic Acid Testing Enhances Pneumococcal Surveillance in Children.Respirology 201115(1):A80
Poster Presentation at Thoracic Society of Australia and New Zealand, Annual Scientific Meeting, Perth, 2011; 16 (Suppl. 1), 37-86

Strachan RE, Gilbert G, Martin A et al. Identification of the Bacterial Causes of Childhood Empyema in Australia by Enhanced Molecular Surveillance. American Journal of Respiratory and Critical Care Medicine 2010; Vol 181:A43277
Poster presentation at American Thoracic Society, New Orleans 2010

Strachan RE, Gilbert GL, Martin A et al. Results of the enhanced pneumococcal surveillance in children with empyema in Australia. Respirology 2010;15(1):A80
Poster Presentation at Thoracic Society of Australia and New Zealand, Annual Scientific Meeting, Brisbane, 2010

Strachan R, Jaffé A. Assessment of the burden of paediatric empyema in Australia.
Respirology 2009;14:Suppl 1. A19
Oral presentation at Thoracic Society of Australia and New Zealand Annual Scientific Meeting, Darwin, Australia 2009

Strachan R, Gilbert L, Martin A et al. Enhanced pneumococcal surveillance in children with empyema in Australia. Respirology 2009;14:Suppl 1. A83
Poster presentation at Thoracic Society of Australia and New Zealand Annual Scientific Meeting, Darwin, Australia 2009

Strachan R, Gilbert L, Martin A, et al (on behalf of the Australasian Research Network in Empyema (ARNiE)). Identifying the bacterial causes of childhood empyema in Australia.
Poster presentation at 13th International Conference for Infectious Diseases, Kuala Lumpar, Malaysia June 2008


Publications

Jaffé A, Strachan RE, Williams KJ. Consent in paediatric research: an evaluation of the guidance provided in the 2007 NHMRC National statement on ethical conduct in human research. Medical Journal of Australia 2008; 189: 347-348 [Letter]

Strachan RE, Jaffe A. Assessment of the burden of paediatric empyema in Australia. Journal of Paediatrics & Child Health 2009; 45:431-436

Strachan RE, Cornelius A, Gilbert G et al. A bedside assay to detect Streptococcus pneumoniae in children with empyema. Pediatric Pulmonology 2010; 46 (2): 179-183

Strachan RE, Jaffe A. Recommendations for managing paediatric empyema thoracis Medical Journal of Australia 2011; 195 (2): 95

Strachan RE, Cornelius A, Gilbert G et al. Bacterial Causes of Emypema in Children, Australia, 2007-2009. Emerg Infect Dis 2011; 17 (10): 1839-1845

Strachan RE, Cornelius A, Gilbert G et al. Pleural fluid nucleic acid testing enhances Pneumococcal surveillance in children. Respirology 2012; 17(1): 114-119

Strachan RE, Snelling TL, Jaffe A. Increased paediatric hospitalizations for empyema in Australia after introduction of the 7-valent pneumococcal conjugate vaccine. WHO Bulletin 2013; 91 (3): 167-173
Public notes

Contacts
Principal investigator
Name 27992 0
Address 27992 0
Country 27992 0
Phone 27992 0
Fax 27992 0
Email 27992 0
Contact person for public queries
Name 11149 0
Roxanne Strachan
Address 11149 0
Sydney Chidlren's Hospital
High Street, Randwick 2031
NSW
Country 11149 0
Australia
Phone 11149 0
+61 2 93820639
Fax 11149 0
+61 2 93820860
Email 11149 0
[email protected]
Contact person for scientific queries
Name 2077 0
A/Prof Adam Jaffe
Address 2077 0
Sydney Chidlren's Hospital
High Street, Randwick 2031
NSW
Country 2077 0
Australia
Phone 2077 0
+61 2 93821111
Fax 2077 0
Email 2077 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIBacterial Causes of Empyema in Children, Australia, 2007–2009 - Volume 17, Number 10—October 2011 - Emerging Infectious Diseases journal - CDC2011https://doi.org/10.3201/eid1710.101825
N.B. These documents automatically identified may not have been verified by the study sponsor.