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Lymphatic Filariasis | Mass Drug Administration for Lymphatic Filariasis and Onchocerciasis for Liberia

Lymphatic Filariasis research study

What is the primary objective of this study?

Approximately 5,200 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis and onchocerciasis endemic areas. Subject selection will not be based on health status. Two sites will be studied, and each study will last for 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these MDA schedules on soil transmitted helminth infections. MDA will be administered by others (Liberian Ministry of Health or Liberian Institute of Biomedical Research). The investigators will test the hypothesis that semiannual mass drug administration (MDA) is superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for control of soil transmitted helminth (STH) infections. 1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF) in these populations. 2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations. 3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.

Who is eligible to participate?

Inclusion Criteria: - • Study areas should be endemic for filariasis and onchocerciasis. - • Study population have limited or no prior experience with MDA. Males and Females greater than 5 years of age. Exclusion Criteria: - • Children less than 6 years of age. - • Children who weigh less than 15 kg (33 lb)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Lymphatic Filariasis

Onchocerciasis

Soil Transmitted Helminth (STH) Infections

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Annual versus Semiannual Albendazole plus Ivermectin Mass Drug AdministrationAnnual or semiannual Albendazole plus Ivermectin, administered by the Liberian Ministry of Health.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Annual Mass Drug AdministrationThis group will receive annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Liberian Ministry of Health.

Semiannual Mass Drug AdministrationThis group will receive semi-annual mass drug administration (Albendazole 400 mg plus Ivermectin) provided by the Liberian Ministry of Health.

Study Status

Active, not recruiting

Start Date: March 2012

Completed Date: October 2017

Phase: N/A

Type: Observational

Design:

Primary Outcome: Microfilaria prevalence based on results of microscopic examination of blood smears and skin snips.

Secondary Outcome: Prevalence of filarial antigenemia in blood and intensity of filarial and intestinal worm infections based on results of microscopy.

Study sponsors, principal investigator, and references

Principal Investigator: Gary J Weil, MD

Lead Sponsor: Washington University School of Medicine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01905436

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