Clinical Trial: Assessment of Drug Efficacy of Local Albendazole

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of Drug Efficacy of Albendazole Bought on Local Market Against Soil-transmitted Helminth Infections in School Children in Jimma, Ethiopia

Brief Summary: Infections with soil-transmitted helminthes (STH) occur throughout the developing world and remain a major public health problem in the poorest communities. Preventive chemotherapy (PC) programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg - the drugs of choice for STH - are administered at the population level, is the main strategy for STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline (GSK) (albendazole (ALB), Zentel) and Johnson & Johnson (mebendazole (MEB), Vermox). In addition to this, there are a wide variety of ALB and MEB tablets available on the local market. Although little is known about the quality of anthelmintics sold for human use, several publications have reported variability in the quality of generic anthelmintics used in veterinary medicine. The main objective of the present study is to compare the efficacy of two ALB brands bought on the local market, including OVIS (Korea, DAEHWA pharmaceutical) and BENDEX (India, Cipla)

Detailed Summary:

  1. Background Infections with soil-transmitted helminthes (STH) occur throughout the developing world and remain a major public health problem in the poorest communities. Infection is caused by four main species of worms commonly known as roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura) and hookworms (Ancylostoma duodenale and Necator americanus) (Bethony et al., 2006). It is estimated that STH affects more than 2 billion people worldwide, of which 450 million have significant morbidity attributable to their infection, and hence are one of the most important neglected tropical diseases. Children and pregnant women are the two most vulnerable groups. Children experience growth stunting and diminished physical fitness as well as impaired memory and cognition, resulting in impaired childhood educational performance and reduce school attendance; pregnant women suffer significant morbidity with hookworm-associated anemia likely contributing to maternal mortality (Bundy et al., 1992; Stoltzfus et al., 1996; Crompton and Neisheim, 2002; WHO 2005; Bethony et al., 2006).

    Preventive chemotherapy (PC) programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg - the drugs of choice for STH - are administered at the population level, is the main strategy for STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline (GSK) (albendazole (ALB), Zentel) and Johnson & Johnson (mebendazole (MEB), Vermox). In addition to this, there are a wide variety of ALB and MEB tablets available on the local market. Although little is known about the quality of anthelmintics sold for human use, several publications have reported variability in the quality of generic anthelmintics used in veterinary medicine. The concentrations of nine anthelmintic product
    Sponsor: University Ghent

    Current Primary Outcome: Egg reduction rate [ Time Frame: 14 days after administration of the drugs ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University Ghent

    Dates:
    Date Received: March 26, 2015
    Date Started: February 2014
    Date Completion:
    Last Updated: April 17, 2015
    Last Verified: April 2015