Fiji Integrated Therapy (FIT) - Triple therapy for lymphatic filariasis, scabies and soil transmitted helminths in Fiji

• Register: ANZCTR
• Last refreshed on: 3 February 2020
• Main ID: ACTRN12617000738325
• Date of registration: 22/05/2017
• Prospective Registration: Yes
• Primary sponsor: Murdoch Children's Research Institute
• Public title: Fiji Integrated Therapy (FIT) - Triple therapy for lymphatic filariasis, scabies and soil transmitted helminths in Fiji
• Scientific 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
• Date of first enrolment: 13/07/2017
• Target sample size: 4000
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000738325.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Fiji

Contacts

• Name: Prof Andrew Steer

• Name: Prof Andrew Steer

Key inclusion & exclusion criteria

Inclusion criteria: All community members will be invited to participate in the study
Exclusion criteria: No informed consent

Age minimum: No limit
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Skin - Dermatological conditions

lymphatic filariasis (LF);scabies;impetigo;soil transmitted helminths (STH);
lymphatic filariasis (LF)
scabies
impetigo
soil transmitted helminths (STH)

Infection - Other infectious diseases

Public Health - Other public health

Intervention(s)

IDA1 Arm:
- ivermectin, diethylcarbamazine and albendazole Day 0,
- permethrin Day 0 if excluded from ivermectin
IDA2 Arm:
- 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 off after 4hrs when less than 2 months; apply to whole body and wash off after 8hrs when 2 months and older.

Directly observed therapy (DOT) will be used for ivermectin, diethylcarbamazine and albendazole.
Instructions will be provided for application of permethrin cream when distributed but application will not be observed, since this is normally done at night to avoid inadvertent washing/rubbing off during daytime activities. Assistance by another person (household member/support person) will be required for application to ensure coverage of whole body.

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 additio

Primary Outcome(s)

Determine the frequency, type, and severity of adverse events following triple drug therapy (IDA) compared to standard two drug therapy (DA) in LF infected and uninfected individuals in a community.

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 moderate to severe symptoms they will have further medical assessments as required.
The majority of adverse events expected are related to effective action of the medications on the parasites. Possible side effects include abdominal pain, nausea, vomiting, diarrhoea, fever, painful glands groin/neck/armpits, itch, swelling, headache, joint pain, fatigue, weakness, dizziness, fainting, racing heart or an allergic reaction (itchy rash, difficulty breathing, chest tightness and/or swelling face/tongue).

Methods of assessment:
LF infection status will be determined by Filiarial Test Strip (FTS) and microfilariae (mf) smears.
Adverse events - interviews +- medical assessment[Community members will be actively followed daily for 2 days after treatment, and passively followed for period 3-7 days after treatment.]

Secondary Outcome(s)

To evaluate the effect of 1 versus 2 doses of ivermectin on impetigo prevalence.

Methods of assessment:
Skin examination[Baseline and 12 months]

To evaluate the impact of IDA on STH (hookworm, ascaris, trichuris and strongyloides) 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).]

To assess the effect of intensity of filarial infection on the frequency and severity of adverse events.

Methods of assessment:
FTS and mf results
Documented adverse events[FTS and mf results at baseline will be compared to documented adverse events monitored for 7 days following treatment.]

To evaluate the impact of IDA on scabies prevalence

Methods of assessment:
Skin examination[Baseline and 12 months
]

To compare the efficacy of IDA to DA administered in communities for clearance of microfilariae (mf) and filarial antigenemia (composite outcome). Methods of assessment: FTS and Dried Blood Spot (DBS) for filarial antigenemia. mf smears and membrane filtration (24 month follow-up only) for microfilariae[Baseline, 12 months and 24 months]

To compare acceptability and feasibility of IDA to DA in communities at risk of LF, scabies and STH (composite outcome).

Methods of assessment:
Acceptability Survey, designed specifically for the Triple therapy studies
Focus group discussions
Interviews with key informants[ Approximately 4 weeks following treatment]

To evaluate the effect of 1 versus 2 doses of ivermectin on scabies prevalence.

Methods of assessment:
Skin examination[Baseline and 12 months]

To evaluate the impact of IDA on impetigo prevalence.

Methods of assessment:
Skin examination[Baseline and 12 months]

Secondary ID(s)

None

Source(s) of Monetary Support

Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Project, Washington University in St Louis

The Task Force for Global Health

Ethics review

Status: Approved
Approval date: 12/09/2016
Contact:

Royal Children's Hospital Melbourne Human Research Ethics Committee

Status: Approved
Approval date: 21/04/2017
Contact:

Fiji National Health Research and Ethics Review Committee

Results

• Date Posted: 15/02/2019
• Date Completed: 24/10/2019