- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00145223
Research for Elim of Filariasis
26 augusti 2010 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Cairo, Egypten, 11566
- Ain Shams University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2003
Avslutad studie
1 juli 2005
Studieregistreringsdatum
Först inskickad
2 september 2005
Först inskickad som uppfyllde QC-kriterierna
2 september 2005
Första postat (Uppskatta)
5 september 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 augusti 2010
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2010
Senast verifierad
1 mars 2007
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 00-015
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på W. Bancrofti Filariasis
-
National Institute of Allergy and Infectious Diseases...Tuberculosis Research Centre, IndiaAvslutadLymfatisk filariasis | Wuchereria Bancrofti-infektionIndien
-
University Hospitals Cleveland Medical CenterWashington University School of MedicineAvslutadWuchereria Bancrofti-infektionElfenbenskusten
-
University of RegensburgUniversity of Heidelberg Medical Center; Charite University, Berlin, Germany och andra samarbetspartnersOkändPankreas Allograft Recipients w/wo njurtransplantationTyskland
-
University Hospitals Cleveland Medical CenterWashington University School of Medicine; Case Western Reserve University; Papua New Guinea Institute for Medical Research och andra samarbetspartnersRekryteringEliminering av lymfatisk filariasis genom massläkemedelsadministration | Övervakning och utvärdering av massläkemedelsadministration för lymfatisk filariasis | Accepterbarhet av massläkemedelsadministration för lymfatisk filariasisPapua Nya Guinea
-
Washington University School of MedicineCase Western Reserve University; Regional Hospital of Agboville, Southern...Aktiv, inte rekryterande
-
University Hospitals Cleveland Medical CenterWashington University School of MedicineAvslutad
-
National Institute of Allergy and Infectious Diseases...Avslutad
-
The Task Force for Global HealthUnited States Agency for International Development (USAID)AvslutadLymfödem | Lymfatisk filariasis | FilariasisMali
-
National Institute of Allergy and Infectious Diseases...Avslutad
-
Washington University School of MedicineNational Institute of Allergy and Infectious Diseases (NIAID)Avslutad