ClinicalTrials.gg
RecruitingNCT07159373BOLTUpdated Oct 7, 2026

Better Options for Lymphatic Filariasis Treatment

A Phase 3 interventional study of MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole and IDA - Ivermectin + DEC + albendazole in Lymphatic Filariasis, Scabies and Strongyloidiasis, sponsored by Medicines Development for Global Health. Recruiting at 1 site in Fiji. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Medicines Development for Global Health · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 7, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
5,100
Allocation
Randomized
Sex
All
01

Study 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
02

Conditions studied

  • Lymphatic Filariasis
  • Scabies
  • Strongyloidiasis

Keywords

  • Moxidectin
  • Ivermectin
  • Mass drug administration
  • Lymphatic filariasis
  • Scabies
  • Strongyloidiasis
  • Cluster-randomized
  • Diethylcarbamazine
  • Albendazole
03

In context

Elephantiasis, Filarial

42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.

This study's planned enrollment of 5,100 is above the median of 1,000 across 27 interventional studies indexed under Elephantiasis, Filarial.

Browse Elephantiasis, Filarial studies →

Lead sponsor

Medicines Development for Global Health is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,100 participants (estimated)

Study arms

  • Experimental
    MoxDA

    Moxidectin + diethylcarbamazine + albendazole

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

  • Active comparator
    IDA

    Ivermectin + diethylcarbamazine + albendazole

    Drug: IDA - Ivermectin + DEC + albendazole

Interventions

  • DrugMoxDA - 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)

  • DrugIDA - 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)

06

What researchers measure

Primary outcomes

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

    Lymphatic filariasis (LF) Mf measured by ultrafiltration

    Time frame: 12 months post-treatment

  2. Incidence and severity of adverse events

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

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

Secondary outcomes

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

    LF Mf measured using ultrafiltration

    Time frame: 24 months post-treatment

  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

    LF Mf measured using ultrafiltration

    Time frame: 12 and 24 months post-treatment

  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

    CFA measured using rapid lateral flow assay

    Time frame: 12 and 24 months post-treatment

  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

    LF Mf measured using ultrafiltration

    Time frame: 12 and 24 months post-treatment

  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

    CFA measured using rapid lateral flow assay

    Time frame: 12 and 24 months post-treatment

  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

    LF Mf measured using ultrafiltration

    Time frame: 12 to 24 months post-treatment

  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

    Lf Mf measured using ultrafiltration

    Time frame: 12 to 24 months post-treatment

  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

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

    Time frame: 12 and 24 months post-treatment

  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

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

    Time frame: 12 and 24 months post-treatment

07

Study locations

1 of 1 sites recruiting
  • Ministry of Health and Medical Services Fiji
    Suva, Fiji
    Recruiting
    • Meciusela Tuicakau, MD · Contactmeciutui2015@gmail.com · +679 332 1500
    • Myra Hardy, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 7, 2026
Sites
Ministry of Health and Medical Services Fiji is now Recruiting
Oct 7, 2026
Start date
Mar 2026→Sep 28, 2026 (actual)
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Not yet recruiting→Recruiting
    Ministry of Health and Medical Services Fiji is now Recruiting
    Start date Mar 2026→Sep 28, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07159373
Lead sponsor
Medicines Development for Global Health
Collaborators
Murdoch Childrens Research Institute, Kirby Institute
Responsible party
Sponsor
First posted
Sep 8, 2025
Start date
Sep 28, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 7, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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