Lymphatic FilariasisPhase 3BOLTNCT07159373
Better Options for Lymphatic Filariasis Treatment
A Phase 3 study testing MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole and IDA - Ivermectin + DEC + albendazole in people with Lymphatic Filariasis and Scabies, run by Medicines Development for Global Health at 1 site in Fiji.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Filariasis, Scabies, Strongyloidiasis
- What is being tested?
- MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole and IDA - Ivermectin + DEC + albendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,100 participants
- Where
- 1 siteFiji
- Study dates
- 28 Sep 2026to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent.
- Resident in one of the study locations.
Who cannot join
- 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;
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fiji1 site, 1 recruiting
- Recruiting
Ministry of Health and Medical Services Fiji
Suva
Meciusela Tuicakau, MD, +679 332 1500, meciutui2015@gmail.com
Myra Hardy, MD
About this study
Official 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
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:
- Does MoxDA clear infection in people with lymphatic filariasis ?
- Does MoxDA cause any medical problems in infected and uninfected people?
Read more
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:
- Be tested to see if they are infected with the parasites that cause lymphatic filariasis, scabies and strongyloidiasis
- Take 3 single doses of MoxDA or IDA, 12 months apart
- Visit their village centre once or twice in the 1 week after each treatment for safety checkups
- Conditions
- Lymphatic Filariasis, Scabies, Strongyloidiasis
- Being tested
- MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole, IDA - Ivermectin + DEC + albendazole
- Keywords
- Moxidectin, Ivermectin, Mass drug administration, Lymphatic filariasis, Scabies, Strongyloidiasis, Cluster-randomized, Diethylcarbamazine, Albendazole
- Medical subject headings
- Elephantiasis, Filarial, Scabies, Strongyloidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxDA - Moxidectin + Diethylcarbamzine (DEC) + AlbendazoleDrug
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 + albendazoleDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| MoxDA | Experimental | Moxidectin + diethylcarbamazine + albendazole Receives: Drug: MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole |
| IDA | Active comparator | Ivermectin + diethylcarbamazine + albendazole Receives: Drug: IDA - Ivermectin + DEC + albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months post-treatment
Incidence and severity of adverse events
Frequency, type, and severity of adverse events reported by treatment group
Measured: 7 days, 12 months and 24 months post-treatment
Secondary outcomes (11)
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
Measured: 24 months post-treatment
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
Measured: 12 and 24 months post-treatment
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
Measured: 12 and 24 months post-treatment
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
Measured: 12 and 24 months post-treatment
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
Measured: 12 and 24 months post-treatment
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
Measured: 12 to 24 months post-treatment
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
Measured: 12 to 24 months post-treatment
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
Measured: Pre- and post-treatment at Baseline and post-treatment at Month 12
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
Measured: 12 and 24 months post-treatment
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
Measured: 12 and 24 months post-treatment
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
Measured: 12 and 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start28 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic FilariasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label trial of mass drug administration with two treatment arms cluster-randomized 1:1 by village and stratified by island.
- Masking
- None (open label)
- Enrolment
- 5,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicines Development for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- Murdoch Childrens Research Institute, Kirby Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159373
- Sponsor's protocol ID
- MDGH-MOX-3003
- Acronym
- BOLT
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07159373
- Acronym / sponsor ID
- BOLT / MDGH-MOX-3003
- Conditions
- Lymphatic Filariasis, Scabies, Strongyloidiasis
- Keywords
- Moxidectin, Ivermectin, Mass drug administration, Lymphatic filariasis, Scabies, Strongyloidiasis, Cluster-randomized, Diethylcarbamazine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,100 participants (estimated)
- Lead sponsor
- Medicines Development for Global HealthUniversity, hospital or other
- Collaborators
- Murdoch Childrens Research Institute, Kirby Institute
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does MoxDA clear infection in people with lymphatic filariasis ?
- 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:
- Be tested to see if they are infected with the parasites that cause lymphatic filariasis, scabies and strongyloidiasis
- Take 3 single doses of MoxDA or IDA, 12 months apart
- Visit their village centre once or twice in the 1 week after each treatment for safety checkups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label trial of mass drug administration with two treatment arms cluster-randomized 1:1 by village and stratified by island.
| Arm | Type | Receives |
|---|---|---|
| MoxDA | Experimental | Drug: MoxDA - Moxidectin + Diethylcarbamzine (DEC) + AlbendazoleMoxidectin + diethylcarbamazine + albendazole |
| IDA | Active comparator | Drug: IDA - Ivermectin + DEC + albendazoleIvermectin + diethylcarbamazine + albendazole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Provision of signed and dated informed consent.
- Resident in one of the study locations.
Key exclusion criteria (9 listed)
- There are no exclusion criteria to participation in the study.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxDA - Moxidectin + Diethylcarbamzine (DEC) + AlbendazoleMass 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) | Drug | MoxDA |
| IDA - Ivermectin + DEC + albendazoleMass 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) | Drug | IDA |
Primary outcome
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
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
11 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole and IDA - Ivermectin + DEC + albendazole in people with Lymphatic Filariasis and Scabies, run by Medicines Development for Global Health at 1 site in Fiji.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Fiji. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.