Lymphatic Filariasis, Scabies, Strongyloidiasis
Conditions
Keywords
Moxidectin, Ivermectin, Mass drug administration, Lymphatic filariasis, Scabies, Strongyloidiasis, Cluster-randomized, Diethylcarbamazine, Albendazole
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: 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
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)
Sponsors
Murdoch Childrens Research Institute
Kirby Institute
Medicines Development for Global Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label trial of mass drug administration with two treatment arms cluster-randomized 1:1 by village and stratified by island.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Provision of signed and dated informed consent. 2. Resident in one of the study locations.
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of microfilariae (Mf)-positive participants at Baseline who are Mf-negative at Month 12 following treatment with MoxDA or IDA | 12 months post-treatment | Lymphatic filariasis (LF) Mf measured by ultrafiltration |
| Incidence and severity of adverse events | 7 days, 12 months and 24 months post-treatment | Frequency, type, and severity of adverse events reported by treatment group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | LF Mf measured using ultrafiltration |
| 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 | CFA measured using rapid lateral flow assay |
| 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 | LF Mf measured using ultrafiltration |
| 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 | CFA measured using rapid lateral flow assay |
| 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 | — |
| 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 | Lf Mf measured using ultrafiltration |
| 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 | Scabies and impetigo measured using modified International Alliance for the Control of Scabies (IACS) criteria based on examination of normally exposed skin |
| 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 | LF Mf measured using ultrafiltration and CFA measured using rapid lateral flow assay |
| 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 | LF Mf measured using ultrafiltration |
| Proportion of Mf-positive participants at Baseline who are Mf-negative at Month 24 following treatment with MoxDA or IDA | 24 months post-treatment | LF Mf measured using ultrafiltration |
Countries
Fiji
Outcome results
None listed