CompletedPhase 3Phase 4ACTRN12618000461291

Fiji Northern Division Ivermectin Mass Drug Administration for Scabies Trial

Does mass Drug Administration for Scabies Result in Control of Serious Bacterial Complications? A Proof of Concept Towards Global Elimination


Sponsor

Murdoch Children's Research Insititute

Enrollment

135,000 participants

Start Date

Jul 16, 2018

Study Type

Interventional

Conditions

Summary

This project aims to evaluate the impact of ivermectin mass drug administration (MDA) for scabies in a large population on the incidence of serious bacterial complications that may arise from scabies and associated impetigo. These complications include skin and soft tissue infections, bloodstream infections, invasive bacterial infections, rheumatic fever and kidney disease. The sample studied will be the population of the Northern Division (~135,000 people) of Fiji whereby ivermectin-based MDA will be offered to all consenting individuals. There will be a 12 month period of surveillance pre and post MDA where incidence of these conditions will be monitored via hospital and clinic presentations and selected village site skin examinations. In addition, this study aims to review the safety, coverage, acceptability, feasibility and cost effectiveness of a large MDA programme compared to standard care. The results from this trial will have direct implications on national public health policy in Fiji and more generally populations where scabies is endemic. The findings of reduced bacterial complications from MDA and health cost averted will greatly strengthen the case for targeted global elimination through MDA.


Eligibility

Sex: Both males and females

Inclusion Criteria1

  • All consenting residents of the Northern Division are eligible to be included in the study

Exclusion Criteria1

  • No treatment will be given to patients who are seriously ill: inpatients in hospital and bedridden in the community.

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Interventions

This is a before-after intervention trial of two doses of ivermectin-based mass drug administration (MDA) delivered to the whole population of the Northern Division of Fiji. Ivermectin will be offe

This is a before-after intervention trial of two doses of ivermectin-based mass drug administration (MDA) delivered to the whole population of the Northern Division of Fiji. Ivermectin will be offered to all consenting individuals of the Northern Division of Fiji unless an indiviudual is: - Pregnant or may be pregnant - Breastfeeding an infant less than 1 week of age - A child less than 90cm in height - Taking warfarin in which case, they will be offered topical permethrin cream instead or If they are requiring inpatient hospitalisation or are bedridden in the community, no intervention will be offered. Initially, the planned dose of ivermectin by height measure was: 90-119cm : 3mg (1 tab) 120-140cm: 6mg (2 tab) 141-158cm: 9mg (3 tab) >158cm: 12mg (4 tab) However, an updated dosing regimen was used referring to the schedule developed by Death to Onchocerciasis and Lymphatic Filariasis, using height-weight correlations in Pacific Island populations. The dosing schedule used is as follows: 90-112cm : 3mg (1 tablet) 113-133cm : 6mg (2 tablets) 134-146cm : 9mg (3 tablets) 147-156cm : 12mg (4 tablets) 157-164cm : 15mg (5 tablets) 165-200cm : 18mg (6 tablets) Permethrin 5% cream: Adults and children apply the cream from neck to toes and leave it on for a minimum of 8 hours and maximum of 24 hours if possible. Infants under 2 months of age to apply head to toe and leave on for maximum of 4 hours. 2 doses of ivermectin or permethrin (if ivermectin contraindicated) will be given 7-14 days apart. There will be no ongoing doses unless an individual is diagnosed with crusted scabies in which case they will be will be treated with 2 doses of ivermectin (except if ivermectin is contraindicated as outlined above) in conjunction with twice weekly permethrin cream for 1 month, with review at 1,2,3,12 and 24 months. Efforts will be made to control these cases intensively to prevent the high mite load of infection associated with crusted scabies from diminishing the effect of the MDA. These cases will be followed up by the Principal Research Coordinator. The intervention will be administered by trained distributors already present in the Northern Division from the previous lymphatic filariasis MDA programme. Ivermectin administration and permethrin application (in children under 90cm in height) will be under directly observed therapy. The planned time frame for this to be accomplished will be within 1 month.


Locations(1)

Northern Division, Fiji

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