Research for Elim of Filariasis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00145223
First received: September 2, 2005
Last updated: August 26, 2010
Last verified: March 2007
  Purpose

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.


Condition
W. Bancrofti Filariasis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Research for Elimination of Human Filariasis

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Study Start Date: August 2003
Estimated Study Completion Date: July 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145223

Locations
Egypt
Ain Shams University
Cairo, Egypt, 11566
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00145223     History of Changes
Other Study ID Numbers: 00-015
Study First Received: September 2, 2005
Last Updated: August 26, 2010
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Wuchereria bancrofti, filariasis, Egypt

Additional relevant MeSH terms:
Filariasis
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014