NCT03177993

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,773 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 randomized 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.

Conditions

• Lymphatic Filariases
• Scabies
• Impetigo
• Soil Transmitted Helminths

Interventions

Type	Name	Description
DRUG	3 drug dose - IDA	Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA). Participants excluded from ivermectin will receive a topical dose of permethrin cream. 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
DRUG	3 drug dose - IDA with second dose of ivermectin	Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA). Eight days after treatment participants will be given a second dose of ivermectin alone. Participants excluded from ivermectin will receive a topical dose of permethrin cream both on day 0 and day 8. 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
DRUG	2 drug dose - DA	Lymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine, and albendazole (DA). If scabies is present in the participant or a household member permethrin cream will be provided 8 days after dose of DA. Exclusion criteria for 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 diethylcarbamazine or albendazole; * pregnant; * breastfeeding within 7 days of delivery; * less than 2 years old; OR * less than 15 kg Exclusion criteria for permethrin: * allergy to permethrin * crusted scabies

Timeline

• Start date: 2017-07-13
• Primary completion: 2017-11-22
• Completion: 2019-10-24
• First posted: 2017-06-06
• Last updated: 2020-12-31

Locations

1 site across 1 country: Fiji