An observational study in Lymphatic Filariases, sponsored by Washington University School of Medicine. Completed at 5 sites in 5 countries. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-31.
Sponsored by Washington University School of Medicine · Observational
This study will assess the impact of 2-drug (DA) or 3-drug (IDA) regimens on lymphatic filariasis infection parameters in communities. Parameters measured will include: circulating filarial antigenemia (CFA) assessed with the Filariasis Test Strip (FTS), antifilarial antibodies tested with plasma and microfilaremia (assessed by night blood smears and microscopy).
Results from clinical trials in Papua New Guinea and Cote d'Ivoire have shown that a single dose of three drugs (ivermectin, diethylcarbamazine, and albendazole [IDA]) was superior to standard two drug therapy (diethylcarbamazine and albendazole [DA]) in clearing W. bancrofti microfilaremia (MF) (King et al. unpublished data).1 Recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if IDA was safe for use in mass drug administration (MDA) (DOLF Project, unpublished data). Currently, there is no information about what community indicators of infection look like following shorter IDA programs. It is possible that current WHO guidelines for stopping MDA need to be modified for MDA programs that use IDA. Observing the levels of infection indicators in a community following treatment with IDA will provide important information to the GPELF if IDA is recommended for use in MDA programs. There is an opportunity to study communities that were treated with IDA during the "Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis". Communities in this study were randomly assigned to receive IDA or DA treatment. A large percentage of individuals in these communities participated in the study thereby approximating a mass distribution of the treatments. By surveying these communities 12 months following their initial treatment the investigators will be able to better understand and compare the impact of MDA with IDA or DA on LF infection parameters at the level of communities.
42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.
This study's enrollment of 20,092 is above the median of 12,930 across 13 observational studies indexed under Elephantiasis, Filarial.
Browse Elephantiasis, Filarial studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
All eligible individuals who reside in the communities where the "Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis" was conducted.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Communities who were treated with diethylcarbamazine and albendazole (DA) mass drug administration during the safety study entitled "Community Based Safety Study of 2-drug (DA) versus 3-drug (IDA) Therapy for Lymphatic Filariasis."
Drug: 2 drug dose - DA
Communities who were treated with ivermectin, diethylcarbamazine and albendazole (IDA) mass drug administration during the safety study entitled "Community Based Safety Study of 2-drug (DA) versus 3-drug (IDA) Therapy for Lymphatic Filariasis."
Drug: 3 drug dose - IDA
Lymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine and albendazole (DA)
Also known as: DA
Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA)
Also known as: IDA
Number of participants with circulating filarial antigenemia (CFA) as measured by the Filaria Test Strip
To assess the impact of DA vs. IDA mass drug administration in community settings participants will be tested using the filaria test strip (FTS) which detects circulating filarial antigen.
Time frame: One sample collected about 12 months after exposure to treatment
Number of participants with IgG4 antifilarial antibodies in plasma
To assess the impact of DA vs. IDA mass drug administration in community settings participant's dried blood spot specimens will be tested using a commercially available antibody test.
Time frame: One sample collected about 12 months after exposure to treatment
Number of participants with microfilaremia as measured with night blood smear testing
To assess the impact of DA vs. IDA mass drug administration in community settings participants with positive FTS will be tested for presence of microfilaria detected by thick blood smear using 60 microliters (ul) from finger prick blood collected at night.
Time frame: One sample collected about 12 months after exposure to treatment
Community prevalence of microfilaremia as measured with night blood smear
Community prevalence of microfilaremia will be compared between the two cohorts to identify any difference of the impact of mass drug administration with IDA or DA
Time frame: One comparison about 12 months after exposure to treatment
Community prevalence of circulating filarial antigen as measured with filarial test strip
Community prevalence of circulating filarial antigen will be compared between the two cohorts to identify any difference of the impact of mass drug administration with IDA or DA
Time frame: One comparison about 12 months after exposure to treatment
Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR
Some sites will include stool sample collections to compare the impact of MDA with IDA or DA on soil transmitted helminth (STH) infection parameters in communities. Stool samples will be analyzed using Kath-katz method, as well as PCR.
Time frame: One comparison about 12 months after exposure to treatment
Plan to share: Yes — Datasets used for published results will be shared publically through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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