Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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?
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.
Secondary ID [1] 282880 0
None
Universal Trial Number (UTN)
U1111-1145-8788
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 289699 0
Condition category
Condition code
Respiratory 290020 290020 0 0
Other respiratory disorders / diseases
Infection 290041 290041 0 0
Studies of infection and infectious agents
Public Health 290042 290042 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 287581 0
Not applicable
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.
Control group
Active

Outcomes
Primary outcome [1] 290067 0
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.
Timepoint [1] 290067 0
These results will be from each admitted episode of pneumonia.
Secondary outcome [1] 303885 0
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.
Timepoint [1] 303885 0
The drugs prescribed during the hospital admission for each episode of pneumonia.

Eligibility
Key inclusion criteria
All children admitted to our hospital from the North Queensland region with pneumonia as their key diagnosis.
Minimum age
0 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adult age.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2013
Actual
24/03/2014
Date of last participant enrolment
Anticipated
28/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1354 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 7187 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 287666 0
Self funded/Unfunded
Name [1] 287666 0
Unfunded
Country [1] 287666 0
Primary sponsor type
Individual
Name
Dr Nathan Smalley
Address
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country
Australia
Secondary sponsor category [1] 286402 0
None
Name [1] 286402 0
Address [1] 286402 0
Country [1] 286402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289630 0
Townsville Hospital Health Service Human Research Ethics Committee
Ethics committee address [1] 289630 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
Ethics committee country [1] 289630 0
Australia
Date submitted for ethics approval [1] 289630 0
25/06/2013
Approval date [1] 289630 0
11/07/2013
Ethics approval number [1] 289630 0
HREC/13/QTHS/115

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?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41642 0
Dr Nathan Smalley
Address 41642 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
Country 41642 0
Australia
Phone 41642 0
+61744331111
Fax 41642 0
Email 41642 0
[email protected]
Contact person for public queries
Name 41643 0
Nathan Smalley
Address 41643 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
Country 41643 0
Australia
Phone 41643 0
+61 7 4433 1111
Fax 41643 0
Email 41643 0
[email protected]
Contact person for scientific queries
Name 41644 0
Nathan Smalley
Address 41644 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
Country 41644 0
Australia
Phone 41644 0
+61 7 4433 1111
Fax 41644 0
Email 41644 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
No additional documents have been identified.