Lymphatic Filariasis Clinical Trial
Official title:
Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast
Approximately 4,000 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
(Ivorian Ministry of Health).
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.
Lymphatic filariasis (LF) is a deforming and disabling infectious disease that causes
elephantiasis and genital deformity (especially hydroceles). The infection affects some 120
million people in 81 countries in tropical and subtropical regions with well over 1 billion
people at risk of acquiring the disease [1]. LF is caused by Wuchereria bancrofti and Brugia
spp. (B. malayi and B.timori), nematode parasites that are transmitted by mosquitoes. This
study is based on the assumption that currently used MDA regimens and schedules are not
optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400
mg plus diethylcarbamazine 6 mg/kg or Alb 400 mg plus Ivermectin (Iver) 200 µg/kg for LF)
were introduced more than 10 years ago.
Onchocerciasis ("Oncho") is similar in some ways to LF in that it is a vector-borne nematode
parasitic disease that causes severe disability. In contrast to LF, this disease causes
blindness and severe skin disease rather than elephantiasis, and it is spread by black flies
instead of mosquitoes. O. volvulus adult worms live in subcutaneous nodules while the adult
worms of the LF parasites live in lymphatic vessels. O. volvulus adult worms are larger and
less sensitive to available drug treatments than those of the species that cause LF and have
a longer lifespan (approximately 14 years rather than the estimated 7 years for LF
parasites). More effective drugs or dosing schedules for MDA against Oncho could shorten the
number of years needed to interrupt Oncho transmission in areas that previously had high
disease rates.
Drugs used for LF MDA are also active against soil transmitted helminth infections (STH,
e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelmintics usually
target special groups of the population, such as schoolchildren, and have limited impact on
transmission. Treatment of the total population and semiannual treatments may reduce
re-infection considerably and will most likely lead to reduced infection densities and
infection prevalence rates. Suppression of STH is an important ancillary benefit of MDA
programs for filarial infections. Increasingly control programs for filariasis and STH are
being integrated with programs for other parasitic diseases such as schistosomiasis. For this
reason, participants will also be tested for schistosomiasis.
Purpose: The study aims to compare the effectiveness once yearly (1X) versus twice yearly
(2X) mass drug administration (MDA) for the elimination of lymphatic filariasis,
onchocerciasis and for control of soil-transmitted helminth infections (intestinal parasites)
in large populations. Mass drug administration will be provided by the Ivory Coast Ministry
of Health. This project will assess the impact of the government's public health program.
Procedures: Study procedures include collection of finger prick blood that will be tested for
microfilariae by microscopy and for serology testing (antigenemia and antibody testing). Skin
snips will be collected and examined by microscopy for the presence of Onchocerca
microfilariae. Stool samples will be collected for detection of parasitic worm eggs by
microscopy. All assays will be performed in Ivory Coast(filarial serology tests, microfilaria
testing, stool examinations).
Washington University researchers developed the protocol, will provide training and guidance
to Ivorian researchers, and work with them to analyze the data. Ivorian researchers will
consent the participants, obtain blood, skin and stool specimens, perform laboratory tests on
the specimens, and enter data on participants and lab results.
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