NCT07159373Not yet recruitingPhase 3
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
Medicines Development for Global Health1 site in 1 country5,100 target enrollmentStarted: March 1, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 5,100
- Locations
- 1
- Primary Endpoint
- Proportion of microfilariae (Mf)-positive participants at Baseline who are Mf-negative at Month 12 following treatment with MoxDA or IDA
Study Overview
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:
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
- •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).
Arms & Interventions
MoxDA
Experimental
Moxidectin + diethylcarbamazine + albendazole
Intervention: MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole (Drug)
IDA
Active Comparator
Ivermectin + diethylcarbamazine + albendazole
Intervention: IDA - Ivermectin + DEC + albendazole (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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(12 and 24 months post-treatment)
- Proportion of Mf-positive participants at Baseline who are Mf-negative at Month 24 following treatment with MoxDA or IDA(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(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(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(12 to 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(12 and 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(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(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(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(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(12 and 24 months post-treatment)
Investigators
Study Sites (1)
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