The Efficacy of Five Anthelmintic Regimes Against Trichuris Trichiura Infections in Schoolchildren in Jimma, Ethiopia
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Infection by Trichuris Trichiura |
Drug: Albendazole, 2 x 400mg Drug: Albendazole 400mg Drug: Mebendazole 500mg Drug: Mebendazole 2 x 500mg Drug: Pyrantel-oxantel + mebendazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia |
- Efficacy against T. trichiura of various treatment regimes [ Time Frame: After two weeks treatment ] [ Designated as safety issue: No ]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
| Enrollment: | 2250 |
| Study Start Date: | December 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Albendazole 400mg
albendazole, 1 x 400mg
|
Drug: Albendazole 400mg
Albendazole 400mg
|
|
Experimental: Albendazole 2 x 400mg
albendazole, 2 x 400mg
|
Drug: Albendazole, 2 x 400mg
Albendazole 2 x 400mg
|
|
Experimental: Mebendazole 500mg
mebendazole, 1 x 500mg
|
Drug: Mebendazole 500mg
Mebendazole 500mg
|
|
Experimental: Mebendazole 2 x 500mg
mebendazole, 2x 500mg
|
Drug: Mebendazole 2 x 500mg
Mebendazole 2 x 500mg
|
|
Experimental: Pyrantel-oxantel + mebendazole
pyrantel-oxantel (10mg/kg)+ mebendazole (500mg)
|
Drug: Pyrantel-oxantel + mebendazole
Pyrantel-oxantel + mebendazole
|
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided by University Ghent
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jozef Vercruysse, University Ghent |
| ClinicalTrials.gov Identifier: | NCT01327469 History of Changes |
| Other Study ID Numbers: | 2010/517 |
| Study First Received: | March 30, 2011 |
| Last Updated: | March 31, 2011 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Trichuriasis Enoplida Infections Adenophorea Infections Nematode Infections Helminthiasis Parasitic Diseases Albendazole Anthelmintics Mebendazole Piperazine Piperazine citrate Pyrantel Pyrantel Pamoate Anticestodal Agents Antiplatyhelmintic Agents |
Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antinematodal Agents Neuromuscular Depolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013