Completed

FITTriple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji

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What is being tested

3 drug dose - IDA

+ 3 drug dose - IDA with second dose of ivermectin

+ 2 drug dose - DA

Drug
Who is being recruted

Vector Borne Diseases+25

+ Mosquito-Borne Diseases

+ Bacterial Infections and Mycoses

+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2017
See protocol details

Summary

Principal SponsorWashington University School of Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 13, 2017

Actual date on which the first participant was enrolled.

This study focuses on three neglected tropical diseases common in Fiji: Lymphatic Filariasis (LF), scabies, and soil transmitted helminths (STH). Currently, LF is managed through a World Health Organization (WHO) eradication program, while scabies and STH are treated individually based on symptoms. The study aims to explore a new triple drug therapy (ivermectin, diethylcarbamazine, and albendazole) that has shown promise in reducing LF prevalence, but needs further safety assessment before it can be widely endorsed. The study is particularly interested in Fiji due to its persistent LF burden despite previous treatments. Additionally, the study will examine the impact of one versus two doses of ivermectin on scabies, and the effectiveness of the new therapy against STH. The acceptability and feasibility of this new therapy in affected communities will also be evaluated.

Official TitleCommunity 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
NCT03177993
Principal SponsorWashington University School of Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4773 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesMosquito-Borne DiseasesBacterial Infections and MycosesBacterial InfectionsEctoparasitic InfestationsElephantiasis, FilarialFilariasisHelminthiasisHemic and Lymphatic DiseasesImpetigoInfectionsLymphatic DiseasesLymphedemaMite InfestationsNematode InfectionsParasitic DiseasesScabiesSkin DiseasesSkin Diseases, InfectiousSkin Diseases, ParasiticStaphylococcal InfectionsStaphylococcal Skin InfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsSecernentea InfectionsSkin Diseases, BacterialSpirurida InfectionsSkin and Connective Tissue Diseases

Criteria

1 inclusion criteria required to participate
All community members that have given written informed consent to participate
1 exclusion criteria prevent from participating
No informed consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
* ivermectin, diethylcarbamazine and albendazole Day 0, * permethrin Day 0 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 o after 4hrs when less than 2 months; apply to whole body and wash off after 8hrs when 2 months and older.

Group II

Experimental
* 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 o after 4hrs when less than 2 months; apply to whole body and wash off after 8hrs when 2 months and older.

Group III

Active Comparator
* diethylcarbamazine and albendazole Day 0 * permethrin Day 8 if scabies present in participant or household member Details of dosing: * 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 o after 8hrs when 2 months and older.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ministry of Health and Medical Services

Suva, FijiOpen Ministry of Health and Medical Services in Google Maps
CompletedOne Study Center