Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
NCT ID: NCT03177993
Last Updated: 2020-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4773 participants
INTERVENTIONAL
2017-07-13
2019-10-24
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDA 1
* 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.
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
IDA 2
* 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.
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
DA
* 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.
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
Interventions
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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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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The Task Force for Global Health
OTHER
Murdoch Childrens Research Institute
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Andrew Steer, PhD
Role: PRINCIPAL_INVESTIGATOR
Murdoch Childrens Research Institute
Gary Weil, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Christopher King, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Ministry of Health and Medical Services
Suva, , Fiji
Countries
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References
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Hardy M, Samuela J, Kama M, Tuicakau M, Romani L, Whitfeld MJ, King CL, Weil GJ, Schuster T, Grobler AC, Engelman D, Robinson LJ, Kaldor JM, Steer AC. Community control strategies for scabies: A cluster randomised noninferiority trial. PLoS Med. 2021 Nov 10;18(11):e1003849. doi: 10.1371/journal.pmed.1003849. eCollection 2021 Nov.
Hardy M, Samuela J, Kama M, Tuicakau M, Romani L, Whitfeld MJ, King CL, Weil GJ, Grobler AC, Robinson LJ, Kaldor JM, Steer AC. Individual Efficacy and Community Impact of Ivermectin, Diethylcarbamazine, and Albendazole Mass Drug Administration for Lymphatic Filariasis Control in Fiji: A Cluster Randomized Trial. Clin Infect Dis. 2021 Sep 15;73(6):994-1002. doi: 10.1093/cid/ciab202.
Other Identifiers
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201607068-2
Identifier Type: -
Identifier Source: org_study_id