ANZCTR - Registration

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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

Streptococcus pneumoniae

Condition category

Condition code

Infection

Studies of infection and infectious agents

Respiratory

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]

Not applicable

Comparator / control treatment

N/A

Control group

Active

Outcomes

Primary outcome [1]

Identify the bacterial causes of empyema, including description and distribution of strains causing pneumococcal empyema

Timepoint [1]

At the completion of the observational study (24 months)

Secondary outcome [1]

To determine incidence and prevelance of empyema, describing epidemiology, clinical features and current management

Timepoint [1]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

GlaxoSmith Kline Biologicals

Address [1]

Rixensart

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney and Illawarra Area Health Service HREC - Northern Sector

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

01/01/2007

Approval date [1]

27/02/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Roxanne Strachan

Address

Sydney Chidlren's Hospital
High Street, Randwick 2031
NSW

Country

Australia

Phone

+61 2 93820639

Fax

+61 2 93820860

Roxanne.Strachan@SESIAHS.HEALTH.NSW.GOV.AU

Contact person for scientific queries

Name

A/Prof Adam Jaffe

Address

Sydney Chidlren's Hospital
High Street, Randwick 2031
NSW

Country

Australia

Phone

+61 2 93821111

Fax

adam.jaffe@unsw.edu.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

Source	Title	Year of Publication	DOI
Dimensions AI	Bacterial Causes of Empyema in Children, Australia, 2007–2009 - Volume 17, Number 10—October 2011 - Emerging Infectious Diseases journal - CDC	2011	https://doi.org/10.3201/eid1710.101825

N.B. These documents automatically identified may not have been verified by the study sponsor.

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