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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5,100
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)
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)
Ministry of Health and Medical Services Fiji
Suva, Fiji
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
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
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
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
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
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
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
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
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
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
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
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
LF Mf measured using ultrafiltration and CFA measured using rapid lateral flow assay
Time frame: 12 and 24 months post-treatment
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