The Efficacy of Five Anthelmintic Regimes Against Trichuris Trichiura Infections in Schoolchildren in Jimma, Ethiopia

NCT01327469 | Completed Phase 4

• 1 other identifier: 2010/517
• Study Type: interventional
• Target: 2,250
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Infection by Trichuris Trichiura

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Albendazole 400mg

EXPERIMENTAL

albendazole, 1 x 400mg

Drug: Albendazole 400mg

Albendazole 2 x 400mg

EXPERIMENTAL

albendazole, 2 x 400mg

Drug: Albendazole, 2 x 400mg

Mebendazole 500mg

EXPERIMENTAL

mebendazole, 1 x 500mg

Drug: Mebendazole 500mg

Mebendazole 2 x 500mg

EXPERIMENTAL

mebendazole, 2x 500mg

Drug: Mebendazole 2 x 500mg

Pyrantel-oxantel + mebendazole

EXPERIMENTAL

pyrantel-oxantel (10mg/kg)+ mebendazole (500mg)

Drug: Pyrantel-oxantel + mebendazole

Interventions

Albendazole 400mg DRUG

Albendazole 400mg

Albendazole 400mg

Albendazole, 2 x 400mg DRUG

Albendazole 2 x 400mg

Albendazole 2 x 400mg

Mebendazole 500mg DRUG

Mebendazole 500mg

Mebendazole 500mg

Mebendazole 2 x 500mg DRUG

Mebendazole 2 x 500mg

Mebendazole 2 x 500mg

Pyrantel-oxantel + mebendazole DRUG

Pyrantel-oxantel + mebendazole

Pyrantel-oxantel + mebendazole

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all school age children who are eligible to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• VLIR-UOS Institutional University Cooperation: collaborator

Study Sites (1)

Jimma University

Jimma, Ethiopia

Location

Related Publications (1)

• Levecke B, Mekonnen Z, Albonico M, Vercruysse J. The impact of baseline faecal egg counts on the efficacy of single-dose albendazole against Trichuris trichiura. Trans R Soc Trop Med Hyg. 2012 Feb;106(2):128-30. doi: 10.1016/j.trstmh.2011.09.007. Epub 2011 Dec 19.

  PMID: 22189084 DERIVED

MeSH Terms

Conditions

Trichuriasis

Interventions

Albendazole; Mebendazole

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jozef Vercruysse, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 1, 2011
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 1, 2011

Record last verified: 2011-03

Locations

ET (1)