The efficacy of mass drug administration strategies to control scabies in a highly endemic population.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613000474752
• Date of registration: 29/04/2013
• Prospective Registration: No
• Primary sponsor: Murdoch Childrens Research Institute, Royal Children's Hospital
• Public title: The efficacy of mass drug administration strategies to control scabies in a highly endemic population.
• Scientific title: The efficacy of mass drug administration strategies to control scabies in a highly endemic population.
• Date of first enrolment: 26/09/2012
• Target sample size: 2058
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12613000474752.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Fiji

Contacts

• Name: Dr Andrew Steer

• Name: Dr Andrew Steer

Key inclusion & exclusion criteria

Inclusion criteria: We have chosen 3 isolated island communities, each with a total population of approximately 800, as the sites for this study. These communities are culturally and geographically similar and are large enough to have a wide distribution of age groups that resembles the national population make up, but are small enough that they are only connected to the main island by a weekly boat service, and so receive relatively few visitors.
All residents of the selected islands, willing to participate and sign a written consent form are eligible to participate in the study.
Exclusion criteria: Person not residents of the selected islands and not willing to sign a written consent form.

Age minimum: No limit
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Epidemiology

Infection - Other infectious diseases

Scabies;Skin sores;Other parasitic diseases (strongyloidiasis, ascariasis and trichuriasis);Lymphatic filariasis;Common skin diseases (fungal infections, eczema);
Scabies
Skin sores
Other parasitic diseases (strongyloidiasis, ascariasis and trichuriasis)
Lymphatic filariasis
Common skin diseases (fungal infections, eczema)

Skin - Dermatological conditions

Intervention(s)

This community intervention trial is a prospective comparison of efficacy and safety of 3 different treatment regimens for scabies. Two of the regimens involve Mass Drug Administration (MDA) and the third is standard of care treatment of symptomatic people and their household contacts. Each of the treatment regimens has beenrandomly assigned to the population of 1 of 3 separate island groups, by a person independent form the investigator. After 100% of the sample is reviewed at the initial study visit, study outcomes and adverse events will be assessed at 3 months (analysing 20% of sample), 12 months (entire sample, 100%), and 24 months (20% of sample), with 12 months being the primary endpoint.

Interventions: Each one of the islands will be assigned to one of the following intervention arms. Assignment will be random, but we note that the study is not formally designed as a randomised trial. In all 3 arms, all residents will be invited to participate, and a skin examination will be undertaken at the initial study visit in those who consent to participate.
1. Oral ivermectin based MDA: Participants will be offered 1 dose of oral ivermectin at 200 ug/kg, unless contra-indicated (as follows). Ivermectin will be replaced by topical permethrin 5% cream in the following “ivermectin contra-indication” groups: children under 15 kg, pregnant and breastfeeding women (as according to onchocerciasis guidelines), people with neurologic disease such as Parkinson’s Disease or cerebral palsy, and people taking medication that is metabolised by the cytochrome p450 pathway. We estimate the number excluded from the ivermectin group to be approximately 20% of the population (10% being children under 15kg and 10% due to pregnancy, lactation or other contraindication); we will d

Primary Outcome(s)

1. To assess the efficacy of MDA using either a) topical permethrin or b) oral ivermectin for scabies, compared to standard of care treatment using topical permethrin, in an endemic population. Efficacy will be measured by clinical examination for scabies and impetigo using a standardised clinical examination tools.[12 months]

2. To assess whether oral ivermectin is at least as effective as topical permetrhin as MDA strategy for scabies. Efficacy will be measured by clinical examination for scabies and impetigo using a standardised clinical examination tools.[12 months]

Secondary Outcome(s)

4. To evaluate the impact of MDA for scabies on other parasitic diseases (strongyloidiasis, ascariasis and trichuriasis), by parasitological examination of stool samples.[12 months]

5. To evaluate the cost-effectiveness of the three alternative treatment regimens. Cost effectiveness will be measured by calculation of an incremental cost effectiveness ratio, defined as the incremental cost per case of scabies adverted.[12 months]

3. To assess the safety of MDA using topical permethrin or oral ivermectin. Safety data will be actively collected in the period 7-14 days after administration of medication by direct questions to participants and passively collected for the duration of the study by collection of data from health clinics.[12 months]

Secondary ID(s)

APP1032310 National Health and Medical Research Council (NHMRC)

Source(s) of Monetary Support

National Health and Medical Research Council (NHMRC)

Secondary Sponsor(s)

University of New South Wales

Ethics review

Status: Approved
Approval date:
Contact:

Fiji National Health Research Ethics Review Committee

Status: Approved
Approval date:
Contact:

Royal Children's Hospital Human Research Ethics Committee