Better Options for Lymphatic Filariasis Treatment

NCT ID: NCT07159373

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 5100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2028-06-30

Brief Summary

The goal of this clinical trial is to learn if mass drug administration with moxidectin in combination with diethylcarbamazine, and albendazole (MoxDA) can treat lymphatic filariasis, scabies and strongyloidiasis in children and adults living in communities where these diseases are common. The main questions it aims to answer are:

1. Does MoxDA clear infection in people with lymphatic filariasis ?

2. Does MoxDA cause any medical problems in infected and uninfected people?

Researchers will compare MoxDA with ivermectin given together with diethylcarbamazine and albendazole (IDA) to see if it works better to clear infection and does not cause any more medical problems.

Participants will:

1. Be tested to see if they are infected with the parasites that cause lymphatic filariasis, scabies and strongyloidiasis

2. Take 3 single doses of MoxDA or IDA, 12 months apart

3. Visit their village centre once or twice in the 1 week after each treatment for safety checkups

Conditions

Lymphatic Filariasis; Scabies; Strongyloidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MoxDA

Moxidectin + diethylcarbamazine + albendazole

Group Type: EXPERIMENTAL

MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole

Intervention Type: DRUG

Mass drug administration with moxidectin co-administered with DEC and albendazole (MoxDA).

Participants who are ineligible to receive moxidectin will be offered modified treatment options:

1. Children aged ≥ 2 years but < 4 years - DEC, albendazole, and permethrin 5% cream

2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5% cream (unless allergic)

IDA

Ivermectin + diethylcarbamazine + albendazole

Group Type: ACTIVE_COMPARATOR

IDA - Ivermectin + DEC + albendazole

Intervention Type: DRUG

Mass drug administration with ivermectin co-administered with DEC and albendazole (IDA).

Participants who are ineligible to receive moxidectin will be offered modified treatment options:

1. Children aged < 2 years or weight < 15 kg - DEC, albendazole, and permethrin 5% cream

2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5% cream (unless allergic)

Interventions

MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole

Mass drug administration with moxidectin co-administered with DEC and albendazole (MoxDA).

Participants who are ineligible to receive moxidectin will be offered modified treatment options:

1. Children aged ≥ 2 years but < 4 years - DEC, albendazole, and permethrin 5% cream

2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5% cream (unless allergic)

Intervention Type: DRUG

IDA - Ivermectin + DEC + albendazole

Mass drug administration with ivermectin co-administered with DEC and albendazole (IDA).

Participants who are ineligible to receive moxidectin will be offered modified treatment options:

1. Children aged < 2 years or weight < 15 kg - DEC, albendazole, and permethrin 5% cream

2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5% cream (unless allergic)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated informed consent.

2. Resident in one of the study locations.

Exclusion Criteria

Participants are ineligible to receive the treatment regimen allocated to their village if they meet any of the following criteria:

1. Severe illness (any illness that is severe enough to interfere with activities of daily living);

2. Known or suspected allergy to ivermectin, moxidectin, diethylcarbamazine or albendazole;

3. Pregnant;

4. Breastfeeding a baby within 7 days of birth;

5. Age < 4 years for villages randomised to moxidectin, diethylcarbamazine, and albendazole (MoxDA); or

6. Age < 2 years or weight < 15 kg for villages randomized to ivermectin, diethylcarbamazine and albendazole (IDA).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Murdoch Childrens Research Institute

OTHER

Sponsor Role: collaborator

Kirby Institute

OTHER_GOV

Sponsor Role: collaborator

Medicines Development for Global Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ministry of Health and Medical Services Fiji

Suva, , Fiji

Countries

Fiji

Facility Contacts

Meciusela Tuicakau, MD

Role: primary

meciutui2015@gmail.com

+679 332 1500

Other Identifiers

MDGH-MOX-3003

Identifier Type: -

Identifier Source: org_study_id