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Trial registered on ANZCTR
Registration number
ACTRN12613000824763
Ethics application status
Approved
Date submitted
22/07/2013
Date registered
26/07/2013
Date last updated
31/03/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
The causes of pneumonia in paediatric patients in North Queensland – should we reconsider our antibiotic strategy?
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Scientific title
Retrospective cohort study of children with pneumonia admitted to our tertiary referral centre from the North Queensland region, assessing the incidence and treatment of multi-resistant organisms, and whether the statewide antibiotic guideline is suitable for our patients.
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Secondary ID [1]
282880
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None
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Universal Trial Number (UTN)
U1111-1145-8788
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumonia
289699
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Condition category
Condition code
Respiratory
290020
290020
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0
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Other respiratory disorders / diseases
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Infection
290041
290041
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0
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Studies of infection and infectious agents
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Public Health
290042
290042
0
0
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Epidemiology
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Assessing the groups in which empirical broader spectrum therapy than that recommended by the statewide guideline may be appropriate, by describing the incidence of drug-resistant disease in our community. Data was collected on all episodes of pediatric pneumonia admitted to the Townsville Hospital between Jan 2009-Jun 2013. This cohort received a variety of antibiotics due to the previous lack of any protocol, and some were commenced by local specialists on broader treatment earlier in the course, while others received what has now become the suggestions in the statewide policy. The control group will be those who were successfully treated in accordance with, what is now, the statewide policy, to compare to those who received alternative options for either clinical reasons or practitioner choice.
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Intervention code [1]
287581
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Not applicable
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Comparator / control treatment
The control group are those patients who received treatment with the standard statewide protocol in institutions or other clinical areas in the hospital, and were successfully treated for simple pneumonia. Data was collected on all episodes of pediatric pneumonia admitted to the Townsville Hospital between Jan 2009-Jun 2013.
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Control group
Active
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Outcomes
Primary outcome [1]
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Incidence of multi-resistant organisms, which will be assessed by searching the pathology results for positive cultures and their sensitivity patterns from samples of sputum, blood and urine.
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Assessment method [1]
290067
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Timepoint [1]
290067
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These results will be from each admitted episode of pneumonia.
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Secondary outcome [1]
303885
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Antibiotics used in treatment, compared to statewide guideline recommendations, which will be assessed by data linkage to the medical record from the time of admission.
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Assessment method [1]
303885
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Timepoint [1]
303885
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The drugs prescribed during the hospital admission for each episode of pneumonia.
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Eligibility
Key inclusion criteria
All children admitted to our hospital from the North Queensland region with pneumonia as their key diagnosis.
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Minimum age
0
Months
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Adult age.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
This is a retrospective cohort study of all episodes of pneumonia admitted to the hospital from Jan 2009-Jun 2013. There will be approx 200-300 cases identified.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/09/2013
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Actual
24/03/2014
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Date of last participant enrolment
Anticipated
28/05/2014
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
1354
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The Townsville Hospital - Douglas
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Recruitment postcode(s) [1]
7187
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4814 - Douglas
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Funding & Sponsors
Funding source category [1]
287666
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Self funded/Unfunded
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Name [1]
287666
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Unfunded
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Address [1]
287666
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Country [1]
287666
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Primary sponsor type
Individual
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Name
Dr Nathan Smalley
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Address
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
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Country
Australia
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Secondary sponsor category [1]
286402
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None
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Name [1]
286402
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Address [1]
286402
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Country [1]
286402
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289630
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Townsville Hospital Health Service Human Research Ethics Committee
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Ethics committee address [1]
289630
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
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Ethics committee country [1]
289630
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Australia
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Date submitted for ethics approval [1]
289630
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25/06/2013
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Approval date [1]
289630
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11/07/2013
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Ethics approval number [1]
289630
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HREC/13/QTHS/115
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Summary
Brief summary
This study will be conducted as a retrospective audit at the Townsville Hospital and will utilise existing hospital records and databases to answer a number of important clinical questions including:
1. What are the identified aetiologies for pneumonia in children in Townsville?
2. In what proportion of cases does the treatment of pneumonia conform to the published guidelines? Where it is not, is a reason for this identified?
3. Are the empirical antibiotics used in the Townsville Hospital for treatment of pneumonia in children appropriate? In what percentage of cases are organisms not sensitive to initial treatment identified (or change of antibiotics required when the patient does not respond)?
4. Are there clinical, demographic, geographic or other features which would indicate that empirical antibiotic treatments recommended in the guidelines are inappropriate in our setting?
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
41642
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Dr Nathan Smalley
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Address
41642
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
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Country
41642
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Australia
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Phone
41642
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+61744331111
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Fax
41642
0
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Email
41642
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[email protected]
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Contact person for public queries
Name
41643
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Dr Nathan Smalley
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Address
41643
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
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Country
41643
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Australia
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Phone
41643
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+61 7 4433 1111
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Fax
41643
0
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Email
41643
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[email protected]
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Contact person for scientific queries
Name
41644
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Dr Nathan Smalley
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Address
41644
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
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Country
41644
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Australia
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Phone
41644
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+61 7 4433 1111
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Fax
41644
0
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Email
41644
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[email protected]
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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.
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