Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000095561
Ethics application status
Approved
Date submitted
19/12/2023
Date registered
2/02/2024
Date last updated
2/02/2024
Date data sharing statement initially provided
2/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing whether testing of rectal swabs is as accurate as bulk faeces testing in diagnosis of bacterial infections.
Scientific title
Rectal Swabs vs Bulk Faeces PCR testing for the Diagnosis of Enteric Conditions (RecSwabFaeces)
Secondary ID [1] 311340 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infectious disease 332420 0
Condition category
Condition code
Infection 329112 329112 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will compare paired stool and rectal swab sample PCR testing to investigate whether rectal swabs are a reliable proxy for faecal sampling. Tests would be done in accordance with normal clinical practice. Persons who would normally be provided with a faecal specimen jar, will also be provided with a rectal swab to perform themselves (within 24 hours of the faeces collection, preferably as the first step). Written instructions with diagrams will be provided to the participant prior to testing. The person will obtain 1x faecal sample and 1x rectal swab sample. Rectal swab collection was carried out at the same time as stool sample production and was obtained by self-insertion via the anus to a depth of 2–3 cm and rotated 3-5 times and ensure it is soiled. Faecal samples and rectal swabs will be returned to a local hospital to be sent to Pathology Queensland. These will be sent to FSS for paired sample testing of Hepatitis A PCR if they are part of a Hepatitis A cluster. The samples will be sent to Pathology Queensland for multiplex PCR assays for a range of organisms (including norovirus) if the setting is in community settings or hospital and not part of an outbreak.
Intervention code [1] 327676 0
Diagnosis / Prognosis
Comparator / control treatment
No control group as we are comparing to the gold standard, which is bulk faeces testing, Bulk faeces testing is using whole turds that are traditionally asked for as human samples during clinical practice.
Control group
Active

Outcomes
Primary outcome [1] 336929 0
Test accuracy of rectal swabs compared to the gold standard of bulk faeces testing
Timepoint [1] 336929 0
Single timepoint tested
Secondary outcome [1] 430192 0
Cycle threshold value differences between rectal swabs and bulk faeces testing
Timepoint [1] 430192 0
Single timepoint (time of test)
Secondary outcome [2] 430766 0
Testing preference
Timepoint [2] 430766 0
After testing, during a routine follow-up phone call

Eligibility
Key inclusion criteria
Persons aged 18 and older

Able to consent to and perform the additional rectal swab test.

Close contact or person exposed, suspected or confirmed case associated with an outbreak of an enteric organism. E.g. hepatitis A outbreak, foodbourne outbreak.

Chronic carrier of an enteric organism that requires testing.

Person involved in a clinical encounter where they are, or likely suffering from a disease caused by an enteric organism. (E.g. person presenting to the GP or Emergency Department with diarrhoea or jaundice)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons unlikely (as judged by the clinician) to be harbouring an enteric organism.

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
We will assess the sensitivity, specificity, positive predictive value, negative predictive value using 2x2 tables. The gold standard will be bulk faeces PCR testing. Sensitivity is the proportion of individuals with the disease who test positive with rectal swabs. Specificity is the proportion of individuals without the disease who test negative with rectal swabs. Sensitivity = True positives / (True positives + False negatives). Specificity = True negatives / (True negatives + False positives). We will assess the cycle threshold values using general linear models if the relationship is linear as expected.
The McNemar test is a non-parametric test used to analyse paired nominal data. It is a test on a 2 x 2 contingency table and checks the marginal homogeneity of two dichotomous variables. The test requires one nominal variable with two categories (dichotomous; disease or no disease) and one independent variable with two dependent groups (rectal swab vs bulk faeces). The minimal sample size required for the McNemar test is at least ten discordant pairs. It should be noted that if the sum of discordant pairs is small (<25), even if the total sample size is large, the statistical power of the McNemar test will be low and the exact binomial test can be used. All results will be reported using 95% confidence intervals.
The R statistical suite will be used for all analyses and data visualisation. All estimates will be presented with 95% confidence intervals (CI). P-values <0.05 are deemed significant, and p-values <0.1 are considered trends.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25957 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 25958 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [3] 26128 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 26129 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 41986 0
4029 - Herston
Recruitment postcode(s) [2] 41987 0
4032 - Chermside
Recruitment postcode(s) [3] 41988 0
4560 - Sunshine Coast
Recruitment postcode(s) [4] 41794 0
4575 - Birtinya
Recruitment postcode(s) [5] 41795 0
4700 - Rockhampton

Funding & Sponsors
Funding source category [1] 315477 0
Government body
Name [1] 315477 0
Forensic Scientific Services
Country [1] 315477 0
Australia
Primary sponsor type
Government body
Name
Sunshine Coast Hospital and Health Service
Address
60 Dalton Drive, Maroochydore, 4558, Queensland
Country
Australia
Secondary sponsor category [1] 317548 0
None
Name [1] 317548 0
Address [1] 317548 0
Country [1] 317548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314386 0
Metro North Health Human Research Ethics Committee (HREC) B (EC00168)
Ethics committee address [1] 314386 0
Level 14 Block 7 Royal Brisbane and Women's Hospital Cnr Butterfield St and Bowen Bridge Rd HERSTON QLD 4029
Ethics committee country [1] 314386 0
Australia
Date submitted for ethics approval [1] 314386 0
08/09/2023
Approval date [1] 314386 0
19/12/2023
Ethics approval number [1] 314386 0
HREC/2023/MNHB/101033

Summary
Brief summary
We are verifying if rectal swabs are as accurate as builk faeces testing in routine clinical care. We hypothesise that these two tests are equally as accurate and it would mean that it is easier to obtain medical tests for gastrointestinal organisms during routine clinical care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131394 0
A/Prof Nicolas Smoll
Address 131394 0
Sunshine Coast Public Health Unit, 60 Dalton Drive, Maroochydore, Queensland 4558
Country 131394 0
Australia
Phone 131394 0
+61 400118807
Fax 131394 0
Email 131394 0
nicolas.smoll@health.qld.gov.au
Contact person for public queries
Name 131395 0
A/Prof Nicolas Smoll
Address 131395 0
Sunshine Coast Public Health Unit, 60 Dalton Drive, Maroochydore, Queensland 4558
Country 131395 0
Australia
Phone 131395 0
+61 7 5202 0000
Fax 131395 0
Email 131395 0
nicolas.smoll@health.qld.gov.au
Contact person for scientific queries
Name 131396 0
A/Prof Nicolas Smoll
Address 131396 0
Sunshine Coast Public Health Unit, 60 Dalton Drive, Maroochydore, Queensland 4558
Country 131396 0
Australia
Phone 131396 0
+61 7 5202 0000
Fax 131396 0
Email 131396 0
nicolas.smoll@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data privacy sharing concerns.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21260Study protocol    387084-(Uploaded-16-01-2024-14-22-33)-Study-related document.docx
21261Informed consent form    387084-(Uploaded-16-01-2024-14-22-21)-Study-related document.docx
21262Ethical approval    387084-(Uploaded-19-12-2023-17-18-42)-Study-related document.pdf



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.