Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000569505
Ethics application status
Approved
Date submitted
25/03/2024
Date registered
6/05/2024
Date last updated
6/05/2024
Date data sharing statement initially provided
6/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assess the feasibility of pharmacies participating in the monitoring of Influenza-Like Illness circulating in the community in individuals aged 18 years and older
Scientific title
Addressing gaps in the surveillance and response to influenza-like illness: A community pharmacy-based feasibility study,
Secondary ID [1] 311506 0
PRN-ILI
Universal Trial Number (UTN)
u1111-1300-6739
Trial acronym
PRN-ILI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza-Like Illness 332958 0
Condition category
Condition code
Infection 329672 329672 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to provide information on the types of viruses causing influenza like symptoms in communities in Aotearoa/New Zealand. Currently only certain GP practices and hospitals swab patients with influenza like symptoms. The results of the swabs taken help to inform our health system with information about what viruses are circulating in the community as well as helping with international efforts to design the flu vaccine for each season. We will compare the swabs taken from community pharmacies with the swabs taken at the GP clinics to see if there is a difference in the types of viruses detected. The inclusion of pharmacies into the sentinel surveillance programme is novel and these results will tell us if pharmacy swabbing is an effective way of collecting this information.

Pharmacists will collect nasopharyngeal swabs (a swab taken high up from the back of the nose) from people with the symptoms of an influenza-like illness. Swabs will be collected if participants meet the eligibility requirements and has given informed consent.

They will only be swabbed once during their visit and their swab will be sent to Environmental Science and Research (ESR) laboratory in Wellington for testing. These swabs will be analysed for the presence of
Influenza, SARS-CoV-2, RSV, Adenovirus, Enterovirus, Metapneumovirus, Parainfluenza and Rhinovirus.
10 days post swabbing participants will be sent a survey via email/text message. This survey will provide feedback of the participants experience participating in the study and to record any changes in their health post swabbing related to the swabbing.
Intervention code [1] 328032 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337456 0
The proportion of samples received by ESR detecting a positive result for a priority acute respiratory pathogen through the annual respiratory illness season.
Timepoint [1] 337456 0
All sample results will be collated and analysed for the primary end point on study completion.
Secondary outcome [1] 431945 0
Number of weeks pharmacists complete 3 samples per week, during the peak winter season compared to the GP sentinel system.
Timepoint [1] 431945 0
End of study
Secondary outcome [2] 431946 0
The proportion of samples received by ESR detecting a positive result for a priority acute respiratory pathogen, compared to the GP sentinel system. These virus subtypes are currently including Influenza, SARS-CoV-2, RSV, Adenovirus, Enterovirus, Metapneumovirus, Parainfluenza and Rhinovirus.
Timepoint [2] 431946 0
End of study
Secondary outcome [3] 431947 0
To assess the acceptability of patients participation in the programme
Timepoint [3] 431947 0
Day 10 post nasopharyngeal swab collection
Secondary outcome [4] 431948 0
To assess the acceptability of pharmacist's participation in the programme
Timepoint [4] 431948 0
End point of study
Secondary outcome [5] 432548 0
To explore inter-seasonal-swabbing, time to three samples per week should aberrant ILI activity emerge, compared to the GP-sentinel system,
Timepoint [5] 432548 0
End of study
Secondary outcome [6] 434496 0
The proportion of samples received by ESR detecting a positive result for any screened ILI.
Timepoint [6] 434496 0
End of Study
Secondary outcome [7] 434497 0
The proportion of samples received by ESR detecting a positive result by viral subtype, compared to the GP sentinel system.
Timepoint [7] 434497 0
End of study

Eligibility
Key inclusion criteria
1. Aged 18 year and over
2. Able and willing to give informed consent to participate
3. confirmed symptoms of ILI, per the sentinel general respiratory surveillance programme:

a. History of fever (subjective or measured) or a measured fever of ³38°C AND
b. Cough, AND
c. Acute onset in the past 10 days
4. Registered with a General Practitioner in New Zealand and willing for the study team to
contact their usual primary care physician
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Nasopharyngeal conditions such as a deviated septum and chronic rhinitis, which the investigator considers could impair ability to swab.
2. Recent facial trauma (30 days)
3. Recent surgery to the facial regional or upper airways, or clinical procedure such as bronchoscopy involving the nasal passages.
4. Chronic nasal blockage
5. History of coagulopathy
6. Current use of anti-coagulant medications
7. Participation in the sentinel general practice respiratory surveillance programme in the
previous four weeks.
8. Participation in the current study within the previous four weeks.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Assuming the same proportion of positive samples obtained by the 2022 GP Sentinel Surveillance (54.3%), 447 samples would achieve reasonable precision to estimate the proportion of positive samples, with a 95% CI of 49.6% to 59.0%. An additional 30 samples will be held back in the case of activity of interest requiring sampling to resume outside of weeks 18 to 39 in order to assess pharmacy response.

Primary objective will be by count and percentage.

Secondary objective will be by ANOVA, Chi-square test, estimation of relative risk, mean, SD, median, minimum and maximum, and by counts (n)0, proportions and cox's proportional hazards regression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/05/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
477
Accrual to date
Final
Recruitment outside Australia
Country [1] 26161 0
New Zealand
State/province [1] 26161 0

Funding & Sponsors
Funding source category [1] 315796 0
Other
Name [1] 315796 0
Te Niwha Infectious Diseases Research Platform
Country [1] 315796 0
New Zealand
Primary sponsor type
Other
Name
Medical Research Institute of New Zealand (MRINZ)
Address
Country
New Zealand
Secondary sponsor category [1] 318030 0
None
Name [1] 318030 0
Address [1] 318030 0
Country [1] 318030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314654 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314654 0
https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
Ethics committee country [1] 314654 0
New Zealand
Date submitted for ethics approval [1] 314654 0
23/02/2024
Approval date [1] 314654 0
26/03/2024
Ethics approval number [1] 314654 0
2024 FULL 19736

Summary
Brief summary
The study is a single group, observational feasibility study.

The purpose of this study is to assess the feasibility of pharmacies participating in the surveillance of ILI circulating in the community in individuals aged 18 years and older. Procedures will align with the sentinel General Practice (GP) surveillance programme, which invites individuals with symptoms of ILI to provide nasopharyngeal swabs (NPS) for viral analysis at ESR. 447 adult participants will be swabbed at participating MRINZ Pharmacy Research Network (PRN) sites from week 18 through to week 39 of 2024, reflecting the increased seasonal prevalence of ILI. 30 further swabs will be reserved to be taken during the inter-seasonal period of 2024 to 2025 in response to ESR determined activity of interest, to assess capacity of the community pharmacy platform to respond acutely.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132298 0
Dr Alex Semprini
Address 132298 0
Medical Research Institute of New Zealand (MRINZ), 7 CSB building wellington hospital, Riddiford street, Newtown 6021
Country 132298 0
New Zealand
Phone 132298 0
+64 21427527
Fax 132298 0
Email 132298 0
alex.semprini@mrinz.ac.nz
Contact person for public queries
Name 132299 0
Dr. Alex Semprini
Address 132299 0
Medical Research Institute of New Zealand (MRINZ), 7 CSB building wellington hospital, Riddiford street, Newtown, 6021, Wellington
Country 132299 0
New Zealand
Phone 132299 0
+64 21427527
Fax 132299 0
Email 132299 0
alex.semprini@mrinz.ac.nz
Contact person for scientific queries
Name 132300 0
Alex Semprini
Address 132300 0
Medical Research Institute of New Zealand (MRINZ). 7 CSB building wellington hospital, Riddiford street, Newtown, 6021, Wellington
Country 132300 0
New Zealand
Phone 132300 0
+64 21427527
Fax 132300 0
Email 132300 0
alex.semprini@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data underlying published results only.
When will data be available (start and end dates)?
Data will be available after the publication of the manuscript, no end date.
Available to whom?
Data will be available to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
For purposes of achieving specific aims outlined in the proposal.
How or where can data be obtained?
Proposals should be directed to Dr Alex Semprini via email (alex.semprini@mrinz.ac.nz)


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.