- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00145223
Research for Elim of Filariasis
26. august 2010 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Cairo, Egypten, 11566
- Ain Shams University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2003
Studieafslutning
1. juli 2005
Datoer for studieregistrering
Først indsendt
2. september 2005
Først indsendt, der opfyldte QC-kriterier
2. september 2005
Først opslået (Skøn)
5. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. august 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2010
Sidst verificeret
1. marts 2007
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 00-015
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .