Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145223
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2005-09-02
Brief Title:
Research for Elim of Filariasis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Research for Elimination of Human Filariasis
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 mgkg 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 200-300school 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None