Lymphatic FilariasisNCT00406627
Research for Elimination of Lymphatic Filariasis (ICIDR)
An observational study of Lymphatic Filariasis, run by Washington University School of Medicine at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Filariasis
- How many people
- 117,500 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2006to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gender, minority and child inclusion: Males and females will be included in population-based village studies without regard to race or ethnic group. There is no reason to exclude pregnant women from population-based studies. There is no reason to exclude children from the village/town studies, and they are included. Younger children will be studied in the school surveys (with large numbers per locality) because they are important sentinels for ongoing filariasis transmission.
- Eligibility for the cohort study: Subjects in household surveys with positive immunochromotography test, filarial antigen tests, and negative microfilaria thick blood smears and who took diethylcarbamazine and albendazole during the Egyptian Program to Eliminate Lymphatic Filariasis will be invited to participate in the study. Subjects must be residents of localities that have met the Basic Elimination criterion (community microfilaria prevalence by thick smear less than 1% or antigen prevalence rate less than 2%). Consenting subjects will be screened further by testing a sample of venous blood collected after 9 p.m. for microfilaremia by membrane filtration and by performing an ELISA to quantitate filarial antigenemia in serum. Eligible subjects will have no microfilaremia by smear and antigen levels > 20 ng/ml.
Who cannot join
- Exclusion of children less than 10 years of age from community studies of filarial antigen and microfilaria prevalence is justified because prevalence rates for these parameters are exceedingly low in young children in low transmission areas like Egypt.
Trial locations and contacts
1 site in 1 country.
About this study
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 23,500 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.
Read the 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 23,500 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.
- Conditions
- Lymphatic Filariasis
- Keywords
- filariasis, lymphatic filariasis, Egypt
- Medical subject headings
- Elephantiasis, Filarial, Filariasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startDec 2006
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic FilariasisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 117,500 participants
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406627
- Sponsor's protocol ID
- 05-0137
- Status last verified
- Sep 2008
- First submitted
- 30 Nov 2006
- Last updated
- 9 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for Elimination of Lymphatic Filariasis (ICIDR)
- ClinicalTrials.gov ID
- NCT00406627
- Acronym / sponsor ID
- 05-0137
- Conditions
- Lymphatic Filariasis
- Keywords
- filariasis, lymphatic filariasis, Egypt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117,500 participants
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 2006
- Study completion
- Dec 2011
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 23,500 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 23,500 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gender, minority and child inclusion: Males and females will be included in population-based village studies without regard to race or ethnic group. There is no reason to exclude pregnant women from population-based studies. There is no reason to exclude children from the village/town studies, and they are included. Younger children will be studied in the school surveys (with large numbers per locality) because they are important sentinels for ongoing filariasis transmission.
- Eligibility for the cohort study: Subjects in household surveys with positive immunochromotography test, filarial antigen tests, and negative microfilaria thick blood smears and who took diethylcarbamazine and albendazole during the Egyptian Program to Eliminate Lymphatic Filariasis will be invited to participate in the study. Subjects must be residents of localities that have met the Basic Elimination criterion (community microfilaria prevalence by thick smear less than 1% or antigen prevalence rate less than 2%). Consenting subjects will be screened further by testing a sample of venous blood collected after 9 p.m. for microfilaremia by membrane filtration and by performing an ELISA to quantitate filarial antigenemia in serum. Eligible subjects will have no microfilaremia by smear and antigen levels > 20 ng/ml.
Key exclusion criteria (1 listed)
- Exclusion of children less than 10 years of age from community studies of filarial antigen and microfilaria prevalence is justified because prevalence rates for these parameters are exceedingly low in young children in low transmission areas like Egypt.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic Filariasis, run by Washington University School of Medicine at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2008.