Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00406627
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2006-11-30
Brief Title:
Research for Elimination of Lymphatic Filariasis ICIDR
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Research for Elimination of Lymphatic Filariasis ICIDR
Status:
COMPLETED
Status Verified Date:
2008-09
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:
The purpose of this study is to check blood samples for lymphatic filariasis to determine whether the recent Program to Eliminate Lymphatic Filariasis was successful in controlling lymphatic filariasis in areas of Egypt Volunteers will participate in a health assessment program carried out by Ain Shams University and approved by the Egyptian Ministry of Health and Population This program includes a brief interview and laboratory tests to detect worm parasites in participants blood Volunteers and family members found to have worms in their blood will be referred for treatment This study will provide early detection of this parasitic infection and referral for prompt treatment in order to prevent spread of the infection to others Approximately 23500 people 6 years of age and older will participate per year Study participants will include people living in areas of Egypt that are known to have the filariasis parasite Volunteers will participate for up to 2 years
Detailed Description:
The purpose of this study is to detect lymphatic filariasis in blood samples to determine whether the recently concluded Program to Eliminate Lymphatic Filariasis has been successful in controlling lymphatic filariasis LF in areas of Egypt The Research and Training Center on Vectors of Diseases RTC at Ain Shams University in Cairo Egypt will be the central site for data management and laboratory studies Field sites localities for village and school surveys are 44 villages and small towns in 27 Districts and 7 governorates in the Nile river delta and in Giza These localities are chosen based on inclusion in the Egyptian National Program to Eliminate Lymphatic Filariasis PELF Other localities will be chosen because of proximity to known endemic localities or a past history of filariasis endemicity The primary study objective is to conduct population-based field studies to address key questions faced during late stages of programs for elimination of lymphatic filariasis ELF The investigators will test the hypothesis that filariasis has been eliminated in Egypt by 5 rounds of Mass Drug Administration MDA and attempt to answer the following questions 1 Has LF been eliminated in localities included in the Egyptian National ELF Program The investigators will study 44 localities 22 per year in alternate years 2 What characteristics in endemic communities affect the likelihood of success or failure for ELF programs The goal here is to identify key characteristics shared by localities that achieved elimination 3 Are there significant foci of infection in localities that were not included in the Egyptian National PELF The investigators will screen 20 new localities per year for the first 3 years of the project The investigators will conduct a cohort study of the natural history of filarial antigenemia in treated populations This study will test two hypotheses a Filarial antigenemia without microfilaremia following completion of a MDA program with diethylcarbamazine and albendazole is of very little parasitological significance That is to say these people are unlikely to develop levels of microfilaremia that support filariasis transmission b Following completion of a MDA program filarial antigen levels in amicrofilaremic subjects will decline over time and disappear without further treatment The investigators will assess the value of advanced diagnostic methods for detecting foci of continued transmission and for early detection of resurgent transmission The duration of this study is 5 years and approximately 23500 people will participate per year Most participants will be studied only once in cross-sectional surveys The study population will include females and males over 6 years of age who live in areas of Egypt that are known to have been endemic or are now suspected to be endemic for bancroftian filariasis Subject selection will not be based on health status A subset of people approximately 120 will be followed in a cohort study for 2 years
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