Research for Elim of Filariasis

August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Research for Elimination of Human Filariasis

Wuchereria bancrofti, is a mosquito-transmitted parasite that causes deforming lymphatic filariasis in the tropics. Improved treatment methods have led to new thinking that it should be possible to interrupt transmission and eliminate this major public health problem by repeated, annual cycles of mass treatment with new single dose combination drug regimens. Egyptian villages involved in the study will be surveyed. Household members above 4 years of age will be tested for filariasis. Also, children in the first year classes of primary schools (5 to 6 years of age) will be tested for parasite infection. Village populations will be treated for filariasis as part of the MOH national filariasis elimination program. Children under age 5, pregnant women, and people with severe underlying illness are excluded from the program.

Study Overview

Status

Completed

Conditions

Detailed Description

Approximately 100 million people are infected with Wuchereria bancrofti, a mosquito-transmitted nemotade parasite that causes deforming lymphatic filariasis in the tropics. Improved therapies and diagnostic methods have led to new thinking about lymphatic filariasis and the realization that it should be possible to interrupt transmission and eliminate the major public health problem by repeated, annual cycles of mass treatment with new single dose combination drug regimens. The Egyptian Ministry of Health is about to institute annual mass therapy with Albendazole (ALB) and diethylcarbamazine (DEC) in all filariasis endemic villages in the country with the aim of eliminating filariasis. This study comprises 4 different activities involving human subjects: These are Village studies of filariasis prevalence and intensity, school studies of antibody prevalence, A treatment trial with an assessment of infectivity of humans with mosquito feeding before and after treatment. Pre-control evaluations of villages will be performed in year 1. Mass treatment will be conducted annually by the MOH, beginning late in year one or early in year 2. Timing of annual follow-up evaluations in years 2-4 will be coordinated with the MOH so that specimens are collected at least 6 months after mass treatment but prior to the next distribution of medication. It is anticipated that the third follow-up collection will be completed by the end of year 4. A final set of follow-up specimens will be collected in year 5 if time permits. The treatment trial will compare effects of diethylcarbamzine (6 mg/kg) and albendazole (400 mg) given as a single dose, 7 consecutive daily doses, or once weekly for 4 weeks. Antibody prevalence in young children (school studies), 200-300/school; infection prevalence studies (village studies sampling humans and mosquitoes), 100 houses (approx. 500 people) per village; treatment trial, n = 60 (20 per treatment group). The project will attempt to measure effects of mass therapy with tools developed in prior studies. It is anticipated that infection prevalence rates and infection intensities will decrease following mass therapy. A successful program should lead to elimination of filariasis over time.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

For village prevalence studies, subjects must reside in villages that are endemic for lymphatic filariasis with MF prevalence rates greater than or equal to 5%. For school studies, subjects must live in endemic villages and attend primary schools.

Exclusion Criteria:

Village studies: Age less than 5 years. School studies: None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 26, 2010

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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