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Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji (FIT)

Primary Purpose

Lymphatic Filariases, Scabies, Impetigo

Status
Completed
Phase
Not Applicable
Locations
Fiji
Study Type
Interventional
Intervention
3 drug dose - IDA
3 drug dose - IDA with second dose of ivermectin
2 drug dose - DA
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphatic Filariases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All community members that have given written informed consent to participate

Exclusion Criteria:

  • No informed consent

Sites / Locations

  • Ministry of Health and Medical Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

IDA 1

IDA 2

DA

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Frequency, type, and severity of adverse events reported by participants following treatment with triple drug therapy (IDA) and standard two drug therapy (DA) in LF infected and uninfected individuals in a community as measured by CTCAE v4.03
Participants will be interviewed and asked to report their general health status at baseline before receiving treatment and daily for the 2 days following treatment (Active Adverse Event Monitoring phase). For 3 to 7 days following treatment, anyone unwell the preceding day will be actively followed, other participants will be interviewed only if they feel unwell and present to the study team (Passive Adverse Event Monitoring phase). At any stage if they describe being unwell, further questions to determine type and severity of symptom(s) experienced will be asked and recorded according to pre-defined adverse event table. If participants report moderate to severe symptoms they will have further medical assessments as required. LF infection status will be determined by Filiarial Test Strip (FTS) and microfilariae (mf) smears.

Secondary Outcome Measures

Clearance of microfilariae (mf) and filarial antigenemia following treatment with IDA or DA in LF infected individuals as measured by microfilaria count in 60ul thick blood smears and filarial test strip rapid diagnostic antigen test.
Methods of assessment: FTS and Dried Blood Spot (DBS) for filarial antigenemia, mf smears for microfilariae
Prevalence of scabies in study population measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
Methods of assessment: Skin examination
Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR at baseline and 12 months after treatment
Methods of assessment: Stool samples will be analysed using Kato-katz method, as well as PCR.
Acceptability and feasibility of IDA and DA in communities at risk of LF, scabies and STH as assessed by survey and focus group discussions.
Methods of assessment: Acceptability Survey, designed specifically for the Triple therapy studies, Focus group discussions, Interviews with key informants
Prevalence of impetigo measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
Methods of assessment: Skin examination

Full Information

First Posted
May 31, 2017
Last Updated
December 30, 2020
Sponsor
Washington University School of Medicine
Collaborators
The Task Force for Global Health, Murdoch Children's Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03177993
Brief Title
Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
Acronym
FIT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
November 22, 2017 (Actual)
Study Completion Date
October 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
The Task Force for Global Health, Murdoch Children's Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Filariases, Scabies, Impetigo, Soil Transmitted Helminths

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4773 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDA 1
Arm Type
Experimental
Arm Description
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.
Arm Title
IDA 2
Arm Type
Experimental
Arm Description
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.
Arm Title
DA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
3 drug dose - IDA
Other Intervention Name(s)
IDA
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
3 drug dose - IDA with second dose of ivermectin
Other Intervention Name(s)
IDA with second dose of ivermectin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
2 drug dose - DA
Other Intervention Name(s)
DA
Intervention Description
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
Primary Outcome Measure Information:
Title
Frequency, type, and severity of adverse events reported by participants following treatment with triple drug therapy (IDA) and standard two drug therapy (DA) in LF infected and uninfected individuals in a community as measured by CTCAE v4.03
Description
Participants will be interviewed and asked to report their general health status at baseline before receiving treatment and daily for the 2 days following treatment (Active Adverse Event Monitoring phase). For 3 to 7 days following treatment, anyone unwell the preceding day will be actively followed, other participants will be interviewed only if they feel unwell and present to the study team (Passive Adverse Event Monitoring phase). At any stage if they describe being unwell, further questions to determine type and severity of symptom(s) experienced will be asked and recorded according to pre-defined adverse event table. If participants report moderate to severe symptoms they will have further medical assessments as required. LF infection status will be determined by Filiarial Test Strip (FTS) and microfilariae (mf) smears.
Time Frame
within 7 days of drug administration
Secondary Outcome Measure Information:
Title
Clearance of microfilariae (mf) and filarial antigenemia following treatment with IDA or DA in LF infected individuals as measured by microfilaria count in 60ul thick blood smears and filarial test strip rapid diagnostic antigen test.
Description
Methods of assessment: FTS and Dried Blood Spot (DBS) for filarial antigenemia, mf smears for microfilariae
Time Frame
Baseline and 12 months
Title
Prevalence of scabies in study population measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
Description
Methods of assessment: Skin examination
Time Frame
Baseline and 12 months
Title
Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR at baseline and 12 months after treatment
Description
Methods of assessment: Stool samples will be analysed using Kato-katz method, as well as PCR.
Time Frame
Stool collected at baseline (pre-treatment), 4 weeks (individual response), and 12 months (community prevalence).
Title
Acceptability and feasibility of IDA and DA in communities at risk of LF, scabies and STH as assessed by survey and focus group discussions.
Description
Methods of assessment: Acceptability Survey, designed specifically for the Triple therapy studies, Focus group discussions, Interviews with key informants
Time Frame
Approximately 4 weeks following treatment
Title
Prevalence of impetigo measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
Description
Methods of assessment: Skin examination
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All community members that have given written informed consent to participate Exclusion Criteria: No informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Steer, PhD
Organizational Affiliation
Murdoch Children's Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Weil, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher King, MD PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Health and Medical Services
City
Suva
Country
Fiji

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Datasets used for published results will be shared publicly through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.
Citations:
PubMed Identifier
34758017
Citation
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.
Results Reference
derived
PubMed Identifier
33728462
Citation
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.
Results Reference
derived

Learn more about this trial

Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji

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