Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000998145
Ethics application status
Approved
Date submitted
19/06/2019
Date registered
15/07/2019
Date last updated
3/04/2023
Date data sharing statement initially provided
15/07/2019
Date results information initially provided
15/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Mycobacterium ulcerans colonise skin prior to clinical Buruli ulcer?
Scientific title
Does Mycobacterium ulcerans colonise skin prior to clinical Buruli ulcer?
Secondary ID [1] 296840 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mycobacterium ulcerans 310753 0
Buruli Ulcer 310754 0
Condition category
Condition code
Infection 309441 309441 0 0
Studies of infection and infectious agents
Skin 311985 311985 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will approach Buruli Ulcer(BU) patients and their friends and relatives living or visiting one endemic area where there is a major outbreak of Buruli ulcer currently (near Melbourne Australia).
After explanation and instruction via leaflet participants will be asked to self-collect skin swabs. They will dip a swab in sterile saline and self-swab their skin after a day outside in the endemic area. They will be asked to swab the back of the elbows, the back of the wrists, ankles and calves on both sides of the body. Participants will also be asked to fill in a questionnaire about their activities and clothing. They will then mail the swabs to our research laboratory, where the swabs will be tested by PCR for the presence of M. ulcerans DNA. Informed written consent will be obtained.
We will also enrol scientists involved in environmental surveys in the outbreak area, and ask them also to swab their elbows, wrists, ankles, backs of calves before showering at the end of the day. These swabs will be tested as above.
Intervention code [1] 313127 0
Early Detection / Screening
Comparator / control treatment
We will enrol at least 10 participants who have not recently visited an endemic area and invite them to also self-collect skin swabs.
Control group
Active

Outcomes
Primary outcome [1] 308405 0
Proportion of participants with detected M. ulcerans on their skin detected by PCR.
Timepoint [1] 308405 0
Swabs will be collected at a single time point on one day chosen by the participant on a day when he or she has been outside for several hours and tested as soon as possible after arrival at our research laboratory, planned to be within 2 weeks.
Secondary outcome [1] 354877 0
Open question in a questionnaire designed specifically for this study to describe activities on the day of swab collection. Participants are free to elaborate as much as they like.
Timepoint [1] 354877 0
Same day as swab collection.
Secondary outcome [2] 372253 0
Open question in a questionnaire designed specifically for this study to describe the amount of clothing at the time of swab collection. Divided in covered or bare upper/lower limbs and feet. Participants could further specify for if they changed for different activities or if they wore protective clothing.
Timepoint [2] 372253 0
Same day as swab collection.

Eligibility
Key inclusion criteria
BU patients known to the principal investigator or the Infectious Diseases team at Austin Health who spend time in an endemic area. Friends and relatives of these patients recruited through the index patient, who stay with or spend time with them in the endemic area. Scientists working with our research team who spend a whole day in the endemic area collecting samples will also be recruited.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A study population of 48 persons exposed to BU endemic areas and 8-10 persons from non-endemic areas are needed to detect a difference in M. ulcerans carriage rate (30% vs 0%, power 80%, alpha 0.05). We plan to include 50 persons in BU endemic areas and 10 persons from non-endemic areas. Differences in M. ulcerans DNA detection rates between persons in BU endemic areas vs non-endemic areas will be calculated by Chi Square.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/01/2019
Date of last participant enrolment
Anticipated
Actual
26/04/2019
Date of last data collection
Anticipated
Actual
30/04/2019
Sample size
Target
60
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12702 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 25123 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301416 0
Hospital
Name [1] 301416 0
Austin Health
Country [1] 301416 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Workaddress:
Infectious Diseases Department
Austin Health
145 Studley Rd
Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 301093 0
None
Name [1] 301093 0
Address [1] 301093 0
Country [1] 301093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302149 0
Austin Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 302149 0
145 Studley Rd,
PO Box 5555 Heidelberg,
3084, Heidelberg
Victoria
Ethics committee country [1] 302149 0
Australia
Date submitted for ethics approval [1] 302149 0
22/11/2017
Approval date [1] 302149 0
09/03/2018
Ethics approval number [1] 302149 0
HREC/17/Austin/581

Summary
Brief summary
Buruli ulcer is a destructive disease of the skin and soft tissue that is caused by the bacterium Mycobacterium ulcerans. There is currently a major outbreak of Buruli ulcer in Victoria, specifically in the Mornington and Bellarine Peninsulas. It is unclear how humans acquire the disease. Further information regarding how Buruli ulcer is transmitted may help to prevent the disease and its complications.
This study is investigating whether people who live in or visit endemic areas carry the bacteria on their skin. This has implications for how Buruli ulcer is transmitted. Participants will self-collect swabs of their skin (of backs of elbows, wrists, calves and ankles), which will be tested for the presence of Mycobacterium ulcerans DNA by PCR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89290 0
Prof Paul Johnson
Address 89290 0
Workaddress:
Infectious Diseases Department
Austin Health
145 Studley Rd
Heidelberg, VIC 3084
Country 89290 0
Australia
Phone 89290 0
+61 3 9496 6676
Fax 89290 0
+61 (03) 9496 6677
Email 89290 0
paul.johnson@austin.org.au
Contact person for public queries
Name 89291 0
Miss Anita Velink
Address 89291 0
Workaddress:
Infectious Diseases Department
Austin Health
145 Studley Rd
Heidelberg, VIC 3084
Country 89291 0
Australia
Phone 89291 0
+61 490092473
Fax 89291 0
Email 89291 0
anita.velink@unimelb.edu.au
Contact person for scientific queries
Name 89292 0
Prof Paul Johnson
Address 89292 0
Workaddress:
Infectious Diseases Department
Austin Health
145 Studley Rd
Heidelberg, VIC 3084
Country 89292 0
Australia
Phone 89292 0
+61 (03) 9496 6678
Fax 89292 0
+61 (03) 9496 6677
Email 89292 0
paul.johnson@austin.org.au

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


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo We found no evidence that adult humans with outdoo... [More Details]

Documents added automatically
No additional documents have been identified.