Research for Elim of Filariasis

W. Bancrofti Filariasis Clinical Trial

Official title:

Research for Elimination of Human Filariasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145223
• Other study ID #: 00-015
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: August 26, 2010
• Start date: August 2003
• Est. completion date: July 2005

Study information

• Verified date: March 2007
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Filariasis
• W. Bancrofti Filariasis

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Egypt,