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

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ClinicalTrials.gov Identifier: NCT03177993
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
The Task Force for Global Health
Murdoch Children's Research Institute
Information provided by (Responsible Party):
Washington University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Lymphatic Filariases Scabies Impetigo Soil Transmitted Helminths Drug: 3 drug dose - IDA Drug: 3 drug dose - IDA with second dose of ivermectin Drug: 2 drug dose - DA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 13, 2017
Actual Primary Completion Date : November 22, 2017
Actual Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: DA




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177993


Locations
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Fiji
Ministry of Health and Medical Services
Suva, Fiji
Sponsors and Collaborators
Washington University School of Medicine
The Task Force for Global Health
Murdoch Children's Research Institute
Investigators
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Principal Investigator: Andrew Steer, PhD Murdoch Children's Research Institute
Principal Investigator: Gary Weil, MD Washington University School of Medicine
Principal Investigator: Christopher King, MD PhD Case Western Reserve University

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03177993     History of Changes
Other Study ID Numbers: 201607068-2
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Impetigo
Filariasis
Elephantiasis, Filarial
Scabies
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Ivermectin
Albendazole
Diethylcarbamazine
Permethrin
Antiparasitic Agents
Anti-Infective Agents