Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07159373

Better Options for Lymphatic Filariasis Treatment

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Lymphatic Filariasis Ectoparasitic Infestations Elephantiasis, Filarial Filariasis Helminthiasis Hemic and Lymphatic Diseases Infections Lymphatic Diseases Lymphedema Mite Infestations Mosquito-Borne Diseases Nematode Infections Parasitic Diseases Rhabditida Infections Scabies Secernentea Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Spirurida Infections Strongyloidiasis Vector Borne Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ministry of Health and Medical Services Fiji

Suva, Fiji

Location contact

Meciusela Tuicakau, MD

CONTACT

[email protected]

+679 332 1500

Myra Hardy, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent.
  • 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:

  • Severe illness (any illness that is severe enough to interfere with activities of daily living);
  • Known or suspected allergy to ivermectin, moxidectin, diethylcarbamazine or albendazole;
  • Pregnant;
  • Breastfeeding a baby within 7 days of birth;
  • Age < 4 years for villages randomised to moxidectin, diethylcarbamazine, and albendazole (MoxDA); or
  • Age < 2 years or weight < 15 kg for villages randomized to ivermectin, diethylcarbamazine and albendazole (IDA).

Treatment and study plan

MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole

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:

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

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:

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

Primary outcomes

  1. Proportion of microfilariae (Mf)-positive participants at Baseline who are Mf-negative at Month 12 following treatment with MoxDA or IDA

    Time frame: 12 months post-treatment

    Lymphatic filariasis (LF) Mf measured by ultrafiltration

  2. Incidence and severity of adverse events

    Time frame: 7 days, 12 months and 24 months post-treatment

    Frequency, type, and severity of adverse events reported by treatment group

Secondary outcomes

  1. Proportion of Mf-positive participants at Baseline who are Mf-negative at Month 24 following treatment with MoxDA or IDA

    Time frame: 24 months post-treatment

    LF Mf measured using ultrafiltration

  2. Mean Mf density and mean change from Baseline at Months 12 and 24 following treatment with MoxDA or IDA in participants who are Mf-positive at Baseline

    Time frame: 12 and 24 months post-treatment

    LF Mf measured using ultrafiltration

  3. Proportion of participants who are circulating filarial antigen (CFA)-positive at baseline who become CFA-negative at Months 12 and/or 24 following treatment with MoxDA or IDA

    Time frame: 12 and 24 months post-treatment

    CFA measured using rapid lateral flow assay

  4. Change in community prevalence of LF, as measured by Mf, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24

    Time frame: 12 and 24 months post-treatment

    LF Mf measured using ultrafiltration

  5. Change in community prevalence of LF, as measured by CFA, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthl

    Time frame: 12 and 24 months post-treatment

    CFA measured using rapid lateral flow assay

  6. Proportion of participants with presence of Mf between Month 12 and Month 24 among those who were Mf positive at Month 12 following treatment with MoxDA or IDA

    Time frame: 12 to 24 months post-treatment

    LF Mf measured using ultrafiltration

  7. Time to first detection of Mf in participants with presence of Mf between Month 12 and Month 24 among those who were Mf positive at Month 12 following treatment with MoxDA or IDA

    Time frame: 12 to 24 months post-treatment

    Lf Mf measured using ultrafiltration

  8. Community acceptability of MDA with MoxDA or IDA assessed by surveys, focus group discussions, and/or key informant interviews before Baseline and approximately 2 months following MDA at Baseline and Month 12

    Time frame: Pre- and post-treatment at Baseline and post-treatment at Month 12

  9. Change in community prevalence of scabies and impetigo at Months 12 and 24 following annual community MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessment between Months 12 and 24

    Time frame: 12 and 24 months post-treatment

    Scabies and impetigo measured using modified International Alliance for the Control of Scabies (IACS) criteria based on examination of normally exposed skin

  10. Change in community seroprevalence of S. stercoralis at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24

    Time frame: 12 and 24 months post-treatment

  11. Change in community prevalence of LF, as measured by Mf and CFA, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24

    Time frame: 12 and 24 months post-treatment

    LF Mf measured using ultrafiltration and CFA measured using rapid lateral flow assay

Sponsors and collaborators

Lead sponsor

Medicines Development for Global Health

Other

Collaborators

  • Kirby Institute
  • Murdoch Childrens Research Institute

Registry information

Official study title

Safety and Efficacy Trial of Mass Drug Administration With Moxidectin Versus Ivermectin in Combination With Diethylcarbamazine and Albendazole for Lymphatic Filariasis, Scabies, and Strongyloidiasis in Fiji

Acronym: BOLT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.