Better Options for Lymphatic Filariasis Treatment (BOLT)

Medicines Development for Global Health

Status and phase: Begins enrollment this month; Phase 3

Conditions: Strongyloidiasis; Lymphatic Filariasis; Scabies

Treatments: Drug: MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole; Drug: IDA - Ivermectin + DEC + albendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT07159373

MDGH-MOX-3003

Details and patient eligibility

About

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

Enrollment: 5,100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Provision of signed and dated informed consent.
2. Resident in one of the study locations.

Exclusion criteria

There are no exclusion criteria to participation in the study.

Treatment 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,100 participants in 2 patient groups

MoxDA

Experimental group

Description:

Moxidectin + diethylcarbamazine + albendazole

Treatment:

Drug: MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole

IDA

Active Comparator group

Description:

Ivermectin + diethylcarbamazine + albendazole

Treatment:

Drug: IDA - Ivermectin + DEC + albendazole