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| Name | Class |
|---|---|
| Murdoch Childrens Research Institute | OTHER |
| Kirby Institute | OTHER_GOV |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MoxDA | Experimental | Moxidectin + diethylcarbamazine + albendazole |
|
| IDA | Active Comparator | Ivermectin + diethylcarbamazine + albendazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole | Drug | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months post-treatment |
| Incidence and severity of adverse events | Frequency, type, and severity of adverse events reported by treatment group | 7 days, 12 months and 24 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion 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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ministry of Health and Medical Services Fiji | Suva | Fiji |
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| ID | Term |
|---|---|
| D004605 | Elephantiasis, Filarial |
| D012532 | Scabies |
| D013322 | Strongyloidiasis |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Open label trial of mass drug administration with two treatment arms cluster-randomized 1:1 by village and stratified by island.
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|
| IDA - Ivermectin + DEC + albendazole | Drug | 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:
|
|
LF Mf measured using ultrafiltration |
| 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 | 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 | 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 | 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 | 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 | 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 | Scabies and impetigo measured using modified International Alliance for the Control of Scabies (IACS) criteria based on examination of normally exposed skin | 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 | LF Mf measured using ultrafiltration and CFA measured using rapid lateral flow assay | 12 and 24 months post-treatment |
| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017196 | Rhabditida Infections |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |