Clinical trial NCT01905423: Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis
Official title: Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphatic Filariasis
Soil Transmitted Helminth Infections
Keywords: Filariasis
Albendazole
Diethylcarbamazine
STH Soil Transmitted Helminths
MDA Mass Drug Administration
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 17108
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study populations are people who live in areas of Indonesia that are endemic for lymphatic filariasis.

Brief summary: Approximately 3,500 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis endemic areas. The study will be performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 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. Purpose of the study is to evaluate different mass drug administration (MDA) regimens for lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of this study may enhance efforts to control and eliminate these important neglected tropical diseases.

The investigators will test the hypothesis that accelerated mass drug administration will be superior to annual MDA for elimination of lymphatic filariasis and for control of soil transmitted helminth infections (STH):

1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF).
2. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.

Detailed description: 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. 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 mass drug administration (MDA) regimens and schedules are not optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400 mg plus diethylcarbamazine (DEC) 6 mg/kg or Alb 400 mg plus ivermectin (Iver) 200 µg/kg for LF) were developed more than 10 years ago.

Drugs used for LF MDA are also active against soil transmitted helminth infections (STH, e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelminthics usually target special groups of the population, such as schoolchildren, and have limited impact on the 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 prevalences. Suppression of STH is an important ancillary benefit of MDA programs for filarial infections.

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 and for control of soil-transmitted helminths (intestinal parasites) in large populations. Mass drug administration will be provided by the Indonesia Ministry of Health. This project will assess the impact of the public health program.

Procedures: Study procedures include collection of finger prick blood that will be tested for microfilaremia and for serology testing (antigenemia and antibody testing). Stool samples will be collected to detect STH infections. All assays will be performed in Indonesia (filarial serology tests, blood smears for detection of microfilariae (MF), and stool examinations for detection of worm eggs).

Washington University researchers developed the protocol, will provide training and guidance to Indonesian researchers, and work with them to analyze the data. Indonesian researchers will consent the participants, obtain stool and blood specimens, perform laboratory tests on the specimens, and enter data on participants and lab results.

Eligibility criteria: Inclusion Criteria:

* Areas should be endemic for filariasis and have limited or no prior experience with MDA. Males and Females greater than or equal to 5 years of age.

Exclusion Criteria:

* Children less than 5 years of age.

Primary outcomes:
measure: Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood
timeFrame: 3 years
Secondary outcomes:
measure: Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests
timeFrame: 3 years
measure: Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test
timeFrame: 3 years
measure: Prevalence of Ascaris Infection
timeFrame: 2 Years
measure: Prevalence of Hookworm Infection
timeFrame: 2 years
measure: Prevalence of Trichuris Infection
timeFrame: 2 years
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: University of Indonesia, Department of Parasitology
state: Java
Study officials:
affiliation: Washington University School of Medicine
name: Peter U Fischer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Gary J Weil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Taniawati Supali, Ph.D.
role: STUDY_DIRECTOR
References: