Infection by Trichuris Trichiura Clinical Trial
Official title:
The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia
| Verified date | March 2011 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris
trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the
most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH
and more than one billion individuals are thought to be infected, of which 450 million have
significant morbidity attributable from their infection, school-aged children in particular.
In this population infections cause stunting of the linear growth, anemia, reduce the
cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are
highly prevalent, affecting more than 60% of the children (data not published).
Current efforts to control STH infections involve periodic mass drug anthelmintic treatment
of infected children in endemic areas and are likely to intensify as more attention is
addressed to the importance of these neglected diseases. Monitoring drug efficacy in these
control programs has become indispensable in order to detect the emergence of resistance
and/or identify confounding factors affecting the drug efficacy. Recently a study has
evaluated a single dose albendazole (ALB) in school age children across 7 countries,
including Ethiopia, revealing that this regime is highly efficacious for the treatment of A.
lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this
parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate.
Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose
10mg/kg), of which the latter holds promise as it can also be administrated to children
between 6 months and 2 years. The main objective of the present study, therefore, is to
assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren
in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x
500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).
| Status | Completed |
| Enrollment | 2250 |
| Est. completion date | March 2011 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 4 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - all school age children who are eligible to participate in the study Exclusion Criteria: - Not willing to participate (no informed consent) - Unable to give samples for follow up - Severe intercurrent medical condition - Diarrhea at first sampling - Study subjects who had treatment for STH in the last 3 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Ethiopia | Jimma University | Jimma |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent | VLIR-UOS Institutional University Cooperation |
Ethiopia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy against T. trichiura of various treatment regimes | The evaluation of the efficacy against T. trichiura of various treatment regimes. To this end, subjects infected with T. trichura (based on McMaster), will be randomly assigned to one of the five proposed treatment regimes. Two weeks after the treatment, faecal egg counts will be performed and the reduction in faecal egg counts will be evaluated | After two weeks treatment | No |