CompletedPhase 4ACTRN12617000738325

Fiji Integrated Therapy (FIT) - Triple therapy for lymphatic filariasis, scabies and soil transmitted helminths in Fiji

Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji


Sponsor

Murdoch Children's Research Institute

Enrollment

4,000 participants

Start Date

Jul 13, 2017

Study Type

Interventional

Conditions

Summary

Lymphatic Filariasis (LF), scabies and soil transmitted helminths (STH) are common neglected tropical diseases affecting the people of Fiji. There is a dedicated LF eradication program supported by the World Health Organization (WHO), however scabies and STH are currently managed on an individual level with symptomatic treatment as required. In an attempt to reduce the prevalence of LF globally, research is being undertaken into alternative, more effective treatment options. A recent study in Papua New Guinea demonstrated a new triple drug therapy (ivermectin, diethylcarbamazine and albendazole) is superior to the currently recommended two drug therapy (diethylcarbamazine and albendazole) used by WHO LF programs in the Pacific. However, adverse events were more frequent. Despite no serious adverse events being observed, it is necessary to conduct further studies to review the safety of this new triple therapy before it can be endorsed as an effective mass drug administration (MDA) regimen for LF in endemic countries. Fiji’s burden of LF, that has been recalcitrant to previous MDA with diethylcarbamazine and albendazole, make it an ideal site to obtain further efficacy and safety data of the triple therapy. Ivermectin given to communities as MDA has been proven to be effective in reducing the community prevalence of scabies. What is not known is the effects of one dose versus two doses of ivermectin as MDA. This question will be reviewed within the design of the community randomised study. The prevalence of impetigo in a community is linked to scabies and this will also be reviewed. Ivermectin and albendazole are both effective individually against STH. The effectiveness of this combination of treatment as MDA in Fiji for STH has not been studied. The effectiveness for the individual in the short-term and the community in the longer-term will be reviewed. In addition, the acceptability and feasibility of the new therapy in communities at risk of these three diseases will be reviewed.


Eligibility

Sex: Both males and females

Inclusion Criteria1

  • All community members will be invited to participate in the study

Exclusion Criteria1

  • No informed consent

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Interventions

IDA1 Arm: - ivermectin, diethylcarbamazine and albendazole Day 0, - permethrin Day 0 if excluded from ivermectin IDA2 Arm: - ivermectin, diethylcarbamazine and albendazole Day 0, ivermectin Day

IDA1 Arm: - ivermectin, diethylcarbamazine and albendazole Day 0, - permethrin Day 0 if excluded from ivermectin IDA2 Arm: - ivermectin, diethylcarbamazine and albendazole Day 0, ivermectin Day 8 - permethrin Day 0 and Day 8 if excluded from ivermectin Details of dosing: - ivermectin: 200 mcg/kg oral - diethylcarbazine: 6mg/kg oral - albendazole 400mg oral - permethrin 5% cream topical: apply to whole body and wash off after 4hrs when less than 2 months; apply to whole body and wash off after 8hrs when 2 months and older. Directly observed therapy (DOT) will be used for ivermectin, diethylcarbamazine and albendazole. Instructions will be provided for application of permethrin cream when distributed but application will not be observed, since this is normally done at night to avoid inadvertent washing/rubbing off during daytime activities. Assistance by another person (household member/support person) will be required for application to ensure coverage of whole body. Exclusion criteria for ivermectin, diethylcarbamazine and albendazole: - severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living); - allergy to ivermectin, diethylcarbamazine or albendazole; - pregnant; - breastfeeding within 7 days of delivery; - less than 2 years old; OR - less than 15 kg In addition if less than 5 years old excluded from ivermectin. Exclusion criteria for permethrin: - allergy to permethrin - crusted scabies


Locations(1)

Rotuma and Gau islands in Eastern Division, Fiji

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ACTRN12617000738325