Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000903189
Ethics application status
Approved
Date submitted
15/05/2019
Date registered
27/06/2019
Date last updated
27/06/2024
Date data sharing statement initially provided
27/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Clinical Registry for Children presenting to Hospital with Respiratory Infections.
Scientific title
The Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) - Clinical Registry
Secondary ID [1] 297931 0
Nil known
Universal Trial Number (UTN)
U1111-1231-3365
Trial acronym
PATRIC
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Infection/ Respiratory Infections 312319 0
Infectious Diseases 312320 0
Condition category
Condition code
Respiratory 310885 310885 0 0
Other respiratory disorders / diseases
Infection 310886 310886 0 0
Other infectious diseases
Public Health 310887 310887 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Weeks
Description of intervention(s) / exposure
The PATRIC Clinical Registry will collect baseline data for children presenting to Perth Children's Hospital with an Acute Respiratory Infection. Emergency Department staff (clinical and/or research staff) will identify and approach prospective participants. ED staff will provide study information (paper or digital) to gain informed consent. Study consent can be obtained by hard paper copy or digitally via a REDCap consent form on a study provided iPad. Once consent is obtained, parents will then be asked to complete a baseline survey on the iPads or via a link sent to their smartphone. Parents will then be contacted via their smartphones for up to four short follow-up surveys (weekly follow up - for a maximum of 4 weeks in total). Each survey will take 5-10 minutes to complete, which will ask questions about parental anxiety, the child's symptoms, the child's level of activity, seeking further healthcare and further treatment. In addition, parents will be asked to provide consent for access to their children's medical records and vaccination history.

Parents are given the option to withdraw from the Clinical Registry at any time. At the beginning of each follow-up survey parents will be asked if they are happy to continue to participate in the registry and if they answer with 'no' they are not sent any further surveys.

Participation in the registry also stops once parents indicate in the follow-up survey that their child is no longer sick. If this occurs, parents won't be sent any further follow-up surveys and are thanked for their time participating in the registry.
Intervention code [1] 314156 0
Not applicable
Comparator / control treatment
No control group. All children who present at Perth Childrens Hospital with cough and fever and have physician-diagnosed acute respiratory infection will be eligible for the registry. Treatment will be as routine clinical care.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319709 0
The proportion of children who have returned to their pre-morbid health state, as assessed by parents/carers reported outcomes by day 7. Outcomes are collected by completion of the study specific questionnaire.
Timepoint [1] 319709 0
Day 7 post presentation at the emergency department and consenting to participate in the clinical registry.
Secondary outcome [1] 369249 0
Time to full recovery of ARI symptoms (in days) assessed by parental questionnaire/survey. The first survey is presented to parents after obtaining consent is specifically designed for this study. Among other questions, it contains 18 questions from the 'Canadian Acute Respiratory Illness and Flu Scale (CARIFS)' (Jacobs et al., J Clin Epidemiol. 2000 Aug;53(8):793-9.) which is a validated survey to measure severity of childhood respiratory infections.
Timepoint [1] 369249 0
Number of days assessed weekly at day 7, 14, 21, and 28 for a maximum of 4 weeks.
Secondary outcome [2] 369250 0
Time to return to normal childhood activities (in days; defined as: sufficient improvement to return to daycare; school; playgroups or other social outings) assessed by parental questionnaire/survey. Parental follow-surveys 1,2,3, and 4 are specifically designed for this study. Among other questions, it contains 18 questions from the 'Canadian Acute Respiratory Illness and Flu Scale (CARIFS)' (Jacobs et al., J Clin Epidemiol. 2000 Aug;53(8):793-9.) which is a validated survey to measure severity of childhood respiratory infections.
Timepoint [2] 369250 0
Number of days assessed weekly at day 7, 14, 21, and 28 for a maximum of 4 weeks.
Secondary outcome [3] 369251 0
Proportion of children who have returned to their pre-morbid health state by day 7, 14, 21 and 28 (d7, d14; d21; d28) assessed by parental questionnaire/survey. Parental follow-up surveys 1,2,3, and 4 are specifically designed for this study. Among other questions, it contains 18 questions from the 'Canadian Acute Respiratory Illness and Flu Scale (CARIFS)' (Jacobs et al., J Clin Epidemiol. 2000 Aug;53(8):793-9.) which is a validated survey to measure severity of childhood respiratory infections.
Timepoint [3] 369251 0
Day 7, 14, 21 and 28 post presentation at the emergency department and providing consent to participate in the clinical registry.
Secondary outcome [4] 369252 0
Proportion of children who are free from cough by day 7, 14, 21 and 28 (d7; d14; d21; d28) assessed by parental questionnaire/survey. Parental follow-up surveys 1,2,3, and 4 are specifically designed for this study. Among other questions, it contains 18 questions from the 'Canadian Acute Respiratory Illness and Flu Scale (CARIFS)' (Jacobs et al., J Clin Epidemiol. 2000 Aug;53(8):793-9.) which is a validated survey to measure severity of childhood respiratory infections.
Timepoint [4] 369252 0
Day 7, 14, 21 and 28 post presentation at the emergency department and providing consent to participate in the clinical registry.
Secondary outcome [5] 369253 0
Proportion of children who are free from fever by day 7, 14, 21 and 28 (d7; d14; d21; d28) assessed by parental questionnaire/survey. Parental follow-up surveys 1,2,3, and 4 are specifically designed for this study. Among other questions, it contains 18 questions from the 'Canadian Acute Respiratory Illness and Flu Scale (CARIFS)' (Jacobs et al., J Clin Epidemiol. 2000 Aug;53(8):793-9.) which is a validated survey to measure severity of childhood respiratory infections.
Timepoint [5] 369253 0
Day 7, 14, 21 and 28 post presentation at the emergency department and consent to participate in the clinical registry.
Secondary outcome [6] 369254 0
Proportion of children with clinical failure (defined as: repeat emergency presentation or hospitalization; general practice re-presentation; modification or unplanned prolongation of antibiotic therapy) by day 7, 14, 21, 28 (d7; d14; d21; d28) assessed by parental questionnaire/survey and medical records. Parental follow-up surveys 1,2,3, and 4 are specifically designed for this study. Among other questions, it contains 18 questions from the 'Canadian Acute Respiratory Illness and Flu Scale (CARIFS)' (Jacobs et al., J Clin Epidemiol. 2000 Aug;53(8):793-9.) which is a validated survey to measure severity of childhood respiratory infections.
Timepoint [6] 369254 0
Day 7, 14, 21 and 28 post presentation at the emergency department and providing consent to participate in the clinical registry.
Secondary outcome [7] 369255 0
Proportion of children intolerant to therapy assessed by parental questionnaire/survey. Parental follow-up surveys 1,2,3, and 4 are specifically designed for this study. Among other questions, it contains 18 questions from the 'Canadian Acute Respiratory Illness and Flu Scale (CARIFS)' (Jacobs et al., J Clin Epidemiol. 2000 Aug;53(8):793-9.) which is a validated survey to measure severity of childhood respiratory infections.
Timepoint [7] 369255 0
Day 0 to 28 post presentation at the emergency department and providing consent to participate in the clinical registry.
Secondary outcome [8] 436861 0
Proportion of parents who missed work due to caring duties assessed as number of days of work missed. Parental follow-up surveys 1,2,3, and 4 are specifically designed for this study. Among other questions, it contains 18 questions from the 'Canadian Acute Respiratory Illness and Flu Scale (CARIFS), (Jacobs et al., J Clin Epidemiol. 2000 Aug;53(8):793-9.)
Timepoint [8] 436861 0
Day 7, 14, 21 and 28 post-presentation at the emergency department and consent to participate in the clinical registry.
Secondary outcome [9] 436862 0
Effectiveness of specific prevention strategies, such as National and State-run immunisation programs, following adjustment for potential confounders as assessed by baseline data collected in a case report form (CRF) from participants providing informed consent.
Timepoint [9] 436862 0
Day 7, 14, 21 and 28 post-presentation at the emergency department and consent to participate in the clinical registry.
Secondary outcome [10] 436863 0
Effectiveness of specific prevention strategies, such as National and State-run immunisation programs, following adjustment for potential confounders as assessed by baseline data collected in a case report form (CRF) from participants providing informed consent.
Timepoint [10] 436863 0
Baseline clinical collected from medical records/administrative databases post-presentation at the emergency department with consent to participate in the clinical registry.

Eligibility
Key inclusion criteria
To be eligible to participate in the PATRIC Clinical Registry, a participant must meet the following criteria:
1. Children aged greater than or equal to 1 months of age and less than or equal to 15 years.
2. Symptoms and signs of ARI:
a. A documented fever greater than or equal to 37.5°C or history of fever in the past 96 hours AND
b. Acute respiratory symptoms including cough and/or flu-like symptoms (e.g. sore throat, rhinorrhoea, fatigue)
3. Total duration of symptoms <21 days at time of enrolment.
Minimum age
1 Months
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potentially eligible individual who meets any of the following criteria will be excluded from participation if the following criteria is met:
1. Children less than 1 month old or greater than 15 years
2. Previous participation in PATRIC within the last 3 months
3. Parents whose English is insufficient to understand study materials
4. Parents unwilling/unable to provide consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size calculation:
The Registry will continue to recruit patients to follow outcomes over time. As such, there is no specific sample size calculation.
Prior to reporting of specific endpoints, statistical power will be assessed to ensure sufficient data to provide robust estimates for the outcome in question.
As of 2024, >2500 children have been enrolled with outcome data available on >1500 children.

Analysis:
Proportion reaching the primary outcome and the median time to reach this outcome, as determined by parental surveys, will be assessed in the PATRIC Clinical Registry. Subgroup analysis, by age group, risk factors and treatments prescribed will be performed. Severe outcomes, including hospital representation, will be cross-checked against the medical record. The proportion lost to follow up prior to return to their premorbid state will also be reported.
Continuous variables will be summarised as mean and standard deviation for symmetric distributions and median and interquartile range (IQR) for asymmetric distributions. Categorical variables will be summarised at each level as frequency and percentage. Frequencies below five will be reported as “<5” to ensure individual confidentiality. Categorical data and time-to-event continuous endpoints will be assessed using standard statistical analytical approaches including Chi-squared; Fisher’s exact tests; Student t-test and Mann-Whitney U test. Predictors of outcomes will be assessed using logistic and linear regression models and Cox regression to account for time dependent outcomes.
These data will inform trial simulations, critical to establishing the PATRIC Platform Trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
9/02/2020
Date of last participant enrolment
Anticipated
1/04/2027
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
4000
Accrual to date
2500
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13608 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 26270 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 302428 0
University
Name [1] 302428 0
University of Western Australia
Country [1] 302428 0
Australia
Funding source category [2] 302467 0
Charities/Societies/Foundations
Name [2] 302467 0
The Ramaciotti Foundation
Country [2] 302467 0
Australia
Funding source category [3] 302470 0
Other Collaborative groups
Name [3] 302470 0
The Telethon Kids Institute
Country [3] 302470 0
Australia
Funding source category [4] 316825 0
Government body
Name [4] 316825 0
National Health and Medical Research Council (NHMRC) Investigator Grant
Country [4] 316825 0
Australia
Funding source category [5] 316826 0
Charities/Societies/Foundations
Name [5] 316826 0
PCH Foundation
Country [5] 316826 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Country
Australia
Secondary sponsor category [1] 302645 0
None
Name [1] 302645 0
Country [1] 302645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303097 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 303097 0
Ethics committee country [1] 303097 0
Australia
Date submitted for ethics approval [1] 303097 0
18/02/2019
Approval date [1] 303097 0
01/04/2019
Ethics approval number [1] 303097 0
RGS0000003078

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 92458 0
Prof Christopher Blyth
Address 92458 0
Telethon Kids Institute, Perth Childrens Hospital 15 Hospital Ave, Nedlands, Western Australia, 6009; Telethon Kids Institute, PO Box 855, West Perth, WA, 6872
Country 92458 0
Australia
Phone 92458 0
+61 8 6456 5614
Fax 92458 0
+61 8 6319 1777
Email 92458 0
christopher.blyth@uwa.edu.au
Contact person for public queries
Name 92459 0
Ms Erin van der Helder
Address 92459 0
Telethon Kids Institute, Perth Childrens Hospital 15 Hospital Ave, Nedlands, Western Australia, 6009; Telethon Kids Institute, PO Box 855, West Perth, WA, 6872
Country 92459 0
Australia
Phone 92459 0
+61 8 6456 8701
Fax 92459 0
+61 8 6319 1777
Email 92459 0
erin.vanderhelder@telethonkids.org.au
Contact person for scientific queries
Name 92460 0
Ms Erin van der Helder
Address 92460 0
Telethon Kids Institute, Perth Childrens Hospital 15 Hospital Ave, Nedlands, Western Australia, 6009; Telethon Kids Institute, PO Box 855, West Perth, WA, 6872
Country 92460 0
Australia
Phone 92460 0
+61 8 6456 8701
Fax 92460 0
+61 8 6319 1777
Email 92460 0
erin.vanderhelder@telethonkids.org.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The investigators may be contacted to request particular de-identified participant level data for other non-profit research and this will be considered on a case by case basis.

Conditions for requesting access:
• -

What individual participant data might be shared?
• The investigators may be contacted to request particular de-identified participant level data and this will be considered on a case by case basis.

What types of analyses could be done with individual participant data?
• To be determined on a case by case basis.

When can requests for individual participant data be made (start and end dates)?
From:
The data will be available after December 2020, with no defined end-date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approval by the Principal Investigator with the requirement to sign a data access agreement. The Principal Investigator can be contacted via email; christopher.blyth@uwa.edu.au

Are there extra considerations when requesting access to individual participant data?
No


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
EmbasePragmatic Adaptive Trial for Respiratory Infection in Children (PATRIC) Clinical Registry protocol.2024https://dx.doi.org/10.1136/bmjopen-2023-074308
N.B. These documents automatically identified may not have been verified by the study sponsor.