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
27/06/2019
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. Treating Emergency Department staff will guide parents to the study information card which will contain information for digital access to further information and study consent. 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.

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 <18 years
2. Symptoms and signs of Acute respiratory infection (ARI): cough plus either a documented fever greater than or equal to 37.5°C or history of fever in the past 96 hours
3. Total duration of symptoms <7 days at time of enrollment
Minimum age
1 Months
Maximum age
18 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 or equal to 1 months old or 18 years and older
2. Previous participation in PATRIC within the last 12 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:
500 patients will be enrolled in the PATRIC Clinical Registry. As this is a pilot study, the sample size is based on the number achievable in the time frame, and the number needed to determine feasibility and to refine assumptions and study design.

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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
31/10/2020
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
500
Accrual to date
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
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Telethon Kids Institute, Perth Children Hospital
15 Hospital Ave,
Nedlands WA
6009
Country
Australia
Secondary sponsor category [1] 302645 0
None
Name [1] 302645 0
Address [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
Office 5E, Perth Children’s Hospital
15 Hospital Avenue, Nedlands WA 6009
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
The aim of PATRIC Clinical Registry is to develop improved evidence based treatment of Acute Respiratory Infections (ARI), the most common reason that children attend the emergency department (ED) for care. The data collected by the PATRIC Clinical Registry will evaluate current treatments for ARI in a variety of patient groups and provide a platform the PATRIC Clinical Trial in the future that will test various interventions in ARI treatment and management.

The PATRIC Clinical Registry will recruit parents and children from the Emergency Department at Perth Childrens Hospital (PCH) utilising an informative video and e-consent form. Following this, engagement with parents will continue with tailored instructions to help the parent care for their child at home as well as weekly follow-up e-surveys also sent directly to their mobile device via text message. The suite of participant materials developed for PATRIC are called Patient Engagement through Technology Solutions (PETS). The aim of PETS is to provide an interactive mobile interface which uses parent-owned hand-held devices for enrollment, data-collection, parental education and follow-up in the PATRIC Clinical Registry.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92458 0
A/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 9340 8222
Fax 92458 0
+61 8 6319 1777
Email 92458 0
[email protected]
Contact person for public queries
Name 92459 0
Dr Rebecca Pavlos
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 6319 1318
Fax 92459 0
+61 8 6319 1777
Email 92459 0
[email protected]
Contact person for scientific queries
Name 92460 0
Dr Rebecca Pavlos
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 6319 1318
Fax 92460 0
+61 8 6319 1777
Email 92460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will 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.
When will data be available (start and end dates)?
The data will be available after December 2020, with no defined end-date.
Available to whom?
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.
Available for what types of analyses?
To be determined on a case by case basis.
How or where can data be obtained?
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; [email protected]


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.