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

December 30, 2020 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4773

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Fiji
      • Suva, Fiji
        • Ministry of Health and Medical Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No informed consent

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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
Other Names:
  • IDA
Experimental: 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.
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
Other Names:
  • IDA with second dose of ivermectin
Active Comparator: 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.
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
Other Names:
  • DA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: within 7 days of drug administration

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.
within 7 days of drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline and 12 months
Methods of assessment: FTS and Dried Blood Spot (DBS) for filarial antigenemia, mf smears for microfilariae
Baseline and 12 months
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
Time Frame: Baseline and 12 months
Methods of assessment: Skin examination
Baseline and 12 months
Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR at baseline and 12 months after treatment
Time Frame: Stool collected at baseline (pre-treatment), 4 weeks (individual response), and 12 months (community prevalence).
Methods of assessment: Stool samples will be analysed using Kato-katz method, as well as PCR.
Stool collected at baseline (pre-treatment), 4 weeks (individual response), and 12 months (community prevalence).
Acceptability and feasibility of IDA and DA in communities at risk of LF, scabies and STH as assessed by survey and focus group discussions.
Time Frame: Approximately 4 weeks following treatment
Methods of assessment: Acceptability Survey, designed specifically for the Triple therapy studies, Focus group discussions, Interviews with key informants
Approximately 4 weeks following treatment
Prevalence of impetigo measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
Time Frame: Baseline and 12 months
Methods of assessment: Skin examination
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Task Force for Global Health
Murdoch Children's Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gary Weil, MD, Washington University School of Medicine
  • Principal Investigator: Andrew Steer, PhD, Murdoch Children's Research Institute
  • Principal Investigator: Christopher King, MD PHD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201607068-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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