W. Bancrofti FilariasisNCT00145223
Research for Elim of Filariasis
An observational study of W. Bancrofti Filariasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- W. Bancrofti Filariasis
- How many people
- Not given
- Where
- 1 siteEgypt
- Study dates
- Aug 2003to Jul 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Village studies: Age less than 5 years. School studies: None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research for Elimination of Human Filariasis
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.
Read the 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.
- Conditions
- W. Bancrofti Filariasis
- Keywords
- Wuchereria bancrofti, filariasis, Egypt
- Medical subject headings
- Filariasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startAug 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for W. Bancrofti FilariasisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145223
- Sponsor's protocol ID
- 00-015
- Status last verified
- Mar 2007
- First submitted
- 2 Sep 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for Elimination of Human Filariasis
- ClinicalTrials.gov ID
- NCT00145223
- Acronym / sponsor ID
- 00-015
- Conditions
- W. Bancrofti Filariasis
- Keywords
- Wuchereria bancrofti, filariasis, Egypt
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2003
- Study completion
- Jul 2005
- First posted
- 5 Sep 2005 (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.
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 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Village studies: Age less than 5 years. School studies: None
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 27 Aug 2010.
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 W. Bancrofti Filariasis, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 1 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 27 Aug 2010. 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 27 Aug 2010.