Assessment of Drug Efficacy of Local Albendazole

December 6, 2022 updated by: University Ghent

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  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). 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.

    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 products (levamisol and MEB) purchased in pharmacies and from agricultural merchants in Kenya varied from 0 to 118 % of their claimed composition. Efficacy studies of seven brands of ALB against gastrointestinal nematodes in sheep in Ethiopia showed that the efficacy of only five of the seven brands was satisfactory.

  2. Objectives 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)

  3. Materials and methods 3.1. Study Population School children between 4 and 18 years old are the focus of this study because of two main reasons: school children are normally a major target for regular treatment with anthelminthic, because they are the group that usually has the heaviest worm burdens for A. lumbricoides and T. trichiura, and are steadily acquiring hookworm infections. In addition, they are in a period of intense physical and intellectual growth. Deworming schoolchildren has a considerable benefit on their nutritional status, physical fitness, appetite, growth and intellectual development.

    3.2. Study design The study design is based on the recent WHO guidelines on how to assess drug efficacy against STH. Briefly, following obtaining informed consent, school children in the target age range group will be recruited and asked to provide a recent stool sample (an interval of less than 4 hours) that will be processed to determine the fecal egg counts (FEC) for each STH present. For the initial sampling the aim is to enroll at least 650 children. This is based on a sample size of at least 50 infected subjects for each STH in each treatment arm (cfr WHO guidelines), an apparent prevalence of 20% for the least prevalent STH species and a drop out of 20%.

    All children providing stool samples will be randomized across two treatment arms. Fourteen days after treatment a second fecal sample will be collected from the children to determine again FEC. Subjects who are unable to provide a stool sample at follow-up, or who are experiencing a severe concurrent medical condition or have diarrhea at time of the first sampling, will be excluded from the study. At follow-up all students will receive a single oral dose ALB tablet that was donated by GSK through WHO (Zentel).

    3.3. Determination of FEC of STH All fecal samples will be processed using the McMaster egg counting technique (analytic sensitivity of 50 EPG) for the detection and the enumeration of infections with A. lumbricoides, T. trichiura and hookworms.

    3.4. Statistical analysis The efficacy of the brands against each of the three STH will be measured by reduction in FEC using the formula below.

    The efficacy of the drugs will be classified into 'satisfactory', 'doubtful' and 'reduced' using the criteria summarized in Table 1.

    Table 1. The criteria based on FECR classifying efficacy of drugs into 'satisfactory', 'doubtful' and 'reduced' A. lumbricoides T. trichiura Hookworm Satisfactory FECR ≥ 95% FECR ≥ 50% FECR ≥ 90% Doubtful 95%> FECR ≥95% 50%> FECR ≥40% 90%> FECR ≥80% Reduced FECR ≤85% FECR ≤40% FECR ≤80%

    3.5. Interpretation In any case of doubtful or reduced efficacy further steps will be taken to assess the efficacy of the drug.

  4. Ethical issues This study will be reviewed by the Ethics committees of the Faculty of Medicine, Ghent University (Belgium) and the Jimma University, Jimma (Ethiopia).

Study Type

Interventional

Enrollment (Actual)

679

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 5-18 years old.
  2. Sex: males and females.
  3. Signed of written informed consent sheet by parents/or guardians, and those who volunteered to comply with study procedures (stool submission, drug treatment).
  4. Females: was not pregnant (as verbally assessed by clinician upon enrolled to treatment).

Exclusion Criteria:

  1. Had vomit within 4 hours after drug administration.
  2. Had diarrhea at time of the first sampling.
  3. Subjects who were unable to provide a stool sample at follow-up,
  4. Subjects who experienced a severe concurrent medical condition
  5. Subjects with known history of allergic reaction to ALB.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ALB-BENDEX
albendazole, 400 mg, single oral dose, (BENDEX)
Drug: albendazole BENDEX
randomized clinical trial with 2 parallel arms
Other Names:
  • BENDEX/OVIS
Active Comparator: ALB-OVIS
albendazole, 400 mg, single-oral dose, (OVIS)
Drug: albendazole OVIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Egg reduction rate
Time Frame: 14 days after administration of the drugs
14 days after administration of the drugs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Jozef Vercruysse, PhD, University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 20, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B670201319330

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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