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Trial registered on ANZCTR


Registration number
ACTRN12609000654257
Ethics application status
Approved
Date submitted
22/06/2009
Date registered
4/08/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Beating scabies and strongyloidiasis in a remote Aboriginal community in the Northern Territory
Scientific title
A before and after study of scabies and strongyloidiasis prevalence in a remote Aboriginal community following the introduction of an ivermectin mass drug administration (MDA) delivered at months 0 and 12.
Secondary ID [1] 252984 0
Ross Andrews
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
strongyloidiasis 3960 0
scabies 4521 0
Condition category
Condition code
Infection 4156 4156 0 0
Other infectious diseases
Public Health 4806 4806 0 0
Epidemiology
Skin 4826 4826 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A population census will be conducted at month 0 & 12 to screen the community for scabies and strongyloidiasis followed by a mass drug administration. The following drugs will be given according to weight and pregnancy status regardless of disease status if the eligible drug has not been given in the previoius 7 days to treat scabies or strongyloidiasis.

- weight 15 kg or more and not pregnant, oral ivermectin 200 microgram/kg immediately
- weight 6kg to <15 kg topical 5% permethrin immediately & 200mg (6-10kg) or 400mg (10-<15kg) oral albendazole daily for 3 days
- weight 3.5kg to <6kg topical 5% permethrin immediately
- <3.5kg topical 10% crotamiton daily for 3 days.

Retreatment at 2-3 weeks for those diagnosed with scabies and/or strongyloidiasis will be administered as the same treatment received 2-3 weeks prior.
Scabies
- non-pregnant and 15 kg or greater, oral ivermectin 200micrograms/kg
- pregnant or =3.5 kg and <15 kg, topical 5% permethrin
- <3.5kg, topical 10% crotamiton daily for 3 days
Strongyloidiasis
- Non-pregnant and 15 kg or greater, oral ivermectin 200 microgram/kg immediately
- 6kg to <15 kg, 200mg (6-10kg) or 400mg (>10kg) oral albendazole daily for 3 days
- pregnant females will be treated with oral ivermectin 1 week after delivery with 200 microgram/kg 2-3 weeks apart if not treated by local practitioners previously
- 0 to <6kg discuss with medical supervisor before treatment

At month 6 and 18 participants diagnosed with disease in the previous 6 months will be followed up along with a percentage of negative participants. Only those diagnosed with disease at these 2 time points will receive treatment that will be administered as 2 treatments 2-3 weeks apart.
Intervention code [1] 3679 0
Prevention
Intervention code [2] 4276 0
Treatment: Drugs
Intervention code [3] 4300 0
Early detection / Screening
Comparator / control treatment
no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5688 0
1. At month 12, demonstrate:
a) a reduction in scabies prevalence from 13% at month 0 to 8% or less. Scabies will be diagnosed clinically and the results of the skin screening performed during the population census at month 0 & 12 will be compared.
Timepoint [1] 5688 0
Month 0 and 12
Primary outcome [2] 238183 0
1. At month 12, demonstrate:
b) a reduction in strongyloidiasis prevalence from 40% at month 0 to 20% or less. A reduction in prevalence will be assessed at month 0 and 12 by comparing the proportion of positive stool samples for children aged <12 years and the equivacol or positive serology results for those aged 12 years and older. Stool specimens will be examined for larvae by microscopy and culture and IgG antibodies to Strongyloides ratti will be measured in serum samples.
Timepoint [2] 238183 0
Month 0 and 12
Secondary outcome [1] 8498 0
Epidemiological features of scabies and strongyloidiasis infections in a remote Aboriginal setting including spatial and household clustering will be collected during the population census at months 0 & 12 and the cross sectional survey at months 6 & 18. Demographic data will be collected on all participants at these time points to describe the epidemiological features. The data will be stratified by age, gender, disease status, treatment given and household lot number using Stata 10 and Global Positioning System(GPS) mapping.
Timepoint [1] 8498 0
Month 0, 6, 12 and 18
Secondary outcome [2] 241552 0
a) Scabies/strongyloidiasis treatment failure and acquisition rates assessed at months 6 and 18. The treatment failure and disease acquisition rates will be determined by comparing the faecal/serology results for strongyloidiasis and the skin screening results for scabies from the population census conducted at months 0 and 12 with the cross sectional survey results collected at months 6 and 18. In exploring differences between susceptibles who did and did not acquire scabies/strongyloidiasis over the follow-up period, GEE will be employed given the potential for clustering by household. Simple (univariate) Generalized Estimating Equation (GEE) will be performed for each explanatory variable of interest.
Timepoint [2] 241552 0
Month 6 and 18
Secondary outcome [3] 242486 0
Proportion of participants reporting any serious adverse events. Reporting of adverse events will be monitored 24-72 hours after administration of oral medications from a questionaire asked prior to administration of medication and compared with answers provided 24-72 hours after administration. The adverse events will be reported as an overall percentage of those who completed the pre and post oral treatment questionaire.
Timepoint [3] 242486 0
Month 0, 6, 12 and 18

Eligibility
Key inclusion criteria
All residents in a remote Aboriginal community and the surrounding homelands that have consented to participate
Minimum age
0 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion from treatment criteria
- Allergy to any of the components of the allocated drug regimen
- Currently on, or has taken ivermectin or completed a 3 day course of albendazole in the previous 7 days
- Has had topical 5% permethrin or completed a 3 day application of 10% crotamiton in the previous 7 days
- Clinical diagnosis of crusted scabies.

Study design
Purpose of the study
Treatment
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
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1804 0
0822

Funding & Sponsors
Funding source category [1] 4143 0
Government body
Name [1] 4143 0
Cooperative Research Centre for Aboriginal Health
Address [1] 4143 0
PO Box 41096
Casuarina, NT 0811
Country [1] 4143 0
Australia
Funding source category [2] 4144 0
Government body
Name [2] 4144 0
Northern Territory Research and Innovation Board
Address [2] 4144 0
GPO Box 3200,
DARWIN NT 0801
Country [2] 4144 0
Australia
Funding source category [3] 4738 0
Other
Name [3] 4738 0
Menzies School of Health Research
Address [3] 4738 0
PO Box 41096
Casuarina, NT 0811
Country [3] 4738 0
Australia
Funding source category [4] 257954 0
Government body
Name [4] 257954 0
National Health and Medical Research Council
Address [4] 257954 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601 .
Country [4] 257954 0
Australia
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
PO Box 41096
Casuarina, NT, 0811
Country
Australia
Secondary sponsor category [1] 4274 0
None
Name [1] 4274 0
Address [1] 4274 0
Country [1] 4274 0
Other collaborator category [1] 626 0
University
Name [1] 626 0
James Cook University
Address [1] 626 0
101 Angus Smith Drive
Townsville QLD 4811
Country [1] 626 0
Australia
Other collaborator category [2] 627 0
University
Name [2] 627 0
Queensalnd Institute of Medical Research
Address [2] 627 0
PO Royal Brisbane Hospital
QLD 4029
Country [2] 627 0
Australia
Other collaborator category [3] 628 0
University
Name [3] 628 0
Charles Sturt Univeristy
Address [3] 628 0
Correspondence Locked Bag 588,
Wagga Wagga,
New South Wales 2678
Country [3] 628 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6742 0
The Human Research Ethics Committee of NT Department of Health and Families and Menzies School of Health Research
Ethics committee address [1] 6742 0
PO Box 41096
Casuarina, NT, 0811
Ethics committee country [1] 6742 0
Australia
Date submitted for ethics approval [1] 6742 0
25/03/2009
Approval date [1] 6742 0
15/05/2009
Ethics approval number [1] 6742 0
09/34

Summary
Brief summary
A before and after study of scabies and strongyloidiasis prevalence in a remote Aboriginal community following the introduction of an ivermectin MDA delivered at months 0 and 12. The assessment of prevalence will be through a population census at months 0 and 12 with a cross sectional survey of treatment failure rates and acquisition rates at months 6 and 18.
All residents in the remote Aboriginal community are eligible for enrolment. Each household in the community will be visited by the research team to explain the project and obtain informed consent. The population census includes screening for scabies and strongyloidiasis and collection of non-specific disease markers.
Participants will then receive ivermectin if they are not pregnant, weight is 15kg or more and they have not been given ivermectin in the previous 7 days. Tretment regimens for those
not eligible for ivermectin are: - Pregnant
females will receive 5% permethrin cream only -weight >3.5kg and <6kg 5% permethrin only, if diagnosed with strongyloidiasis discuss with medical supervisor - weight >6 kg and <15 kg albendazole 200mg
(6-10kg) or 400mg (>10kg)and 5% permethrin.
- weight <3.5kg 10% crotamiton only
Participants diagnosed with scabies or
strongyloidiasis will receive a repeat treatment
after 2-3 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29117 0
Address 29117 0
Country 29117 0
Phone 29117 0
Fax 29117 0
Email 29117 0
Contact person for public queries
Name 12274 0
Therese Kearns
Address 12274 0
PO Box 41096
Casuarina, NT, 0811
Country 12274 0
Australia
Phone 12274 0
+61 407 190 675
Fax 12274 0
+61 8 8927 5187
Email 12274 0
therese.kearns@menzies.edu.au
Contact person for scientific queries
Name 3202 0
Therese Kearns
Address 3202 0
PO Box 41096
Casuarina, NT, 0811
Country 3202 0
Australia
Phone 3202 0
+61 8 8922 8196
Fax 3202 0
+61 8 8927 5187
Email 3202 0
therese.kearns@menzies.edu.au

No information has been provided regarding IPD availability
Summary results
No Results