Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon (BenziR)

July 26, 2021 updated by: Centre de Recherche Médicale de Lambaréné
Soil-transmitted helminths (STHs) infections are common in subtropics and mostly affect the poorest communities, with an impact on human health in many parts of the world. In 2017, World Health organization (WHO) reports more than 1.5 billion people are infected with soil-transmitted helminths worldwide, including 568 million school-age children who need treatment and preventive interventions. Preventive chemotherapy and periodic mass administration with benzimidazoles (BZ) [albendazole (ABZ) and mebendazole (MBZ)] are used to control these parasites. However, rapid reinfection with Ascaris lumbricoides within six months after a completed treatment has been reported, while the reinfection with hookworms is slow. Similarly, the efficacy of these drugs on Trichuris trichiura cure rate is poor. After many years of use of this drug class, there is an increase possibility that BZ resistance could develop. This resistance may occur due to single nucleotide polymorphisms (SNPs) in the β-tubulin gene at positions 167, 198 or 200, as has been reported in animals. Little data exist to show whether any of these polymorphisms do influence the BZ efficacy against STH in humans. The present study will develop methods to look for molecular evidence of BZ drug resistance in human population in order to support the investigation of the control and elimination of neglected tropical diseases (NTDs) in our communities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Randomized Controlled Clinical Trial (RCT) cohort study, to evaluate the efficacy and safety of three benzimidazole derivates drug (Albendazole, Mebendazole, Albendazole Mebendazole, and Albendazole-Pyrantel) to treat major STH in school aged children from Lambaréné and surroundings. After obtaining informed consent from parents or guardians, stool samples will be collected, for infectious status. If positive the participant will be treated with either drug combination. The efficacy and SNP frequencies will be assessed at weeks 3 and 6 post treatment

Description of study population Children of school and preschool age (2 to 17 years old) living in Lambaréné and the surrounding areas are eligible. The choice of school and preschool-aged children is based on the fact that they constitute the main population at risk of infection. In addition, most of the resources available for public health interventions in many endemic areas of soil-transmitted helminths target this group as a cost-effective method for reaching a large part of the population.

The previous analysis of patient cohort reported a success rate of 61% multispecies prevalence amongst children in the study area and considering a significance level of 95% confidence interval (α =5%) and a minimum power of 80%, the investigators will have to include a total of 255 participants in the study

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gabon
    • Moyen- Ogooué
      • Lambaréné, Moyen- Ogooué, Gabon, 1437
        • Centre de Recherches Médicales de Lammbaréné

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

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Living in Lambaréné and surrounding areas
  • Written informed consent or assent
  • Microscopy positive for any major Soil-Transmitted helminths

Exclusion Criteria:

  • Microscopy negative for any STH
  • Pregnant women
  • Do not be available for followed up.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Albendazole
ABZ (400mg)
Drug: Benzimidazole Anthelmintic
The participants diagnosed positive will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study.
Other Names:
  • Mebendazole
  • Albendazole
  • Pyrantel
Experimental: Albendazole and Mebendazole
ABZ 400mg + 1 tablet of MBZ (500mg)
Drug: Benzimidazole Anthelmintic
The participants diagnosed positive will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study.
Other Names:
  • Mebendazole
  • Albendazole
  • Pyrantel
Experimental: Albendazole and Pyrantel
ABZ (400mg) + Pyr (125 mg)
Drug: Benzimidazole Anthelmintic
The participants diagnosed positive will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study.
Other Names:
  • Mebendazole
  • Albendazole
  • Pyrantel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of eggs rate reduction .
Time Frame: three weeks to six weeks

The assessment of efficacy will be the level of the eggs rate reduction . The assessment will be done at weeks 3 and 6 and a different treatment regimen will be compared according to protocol and intention to treat.

This evaluation will be based on the same parasitological examinations carried out at the beginning. Using polymerase chain reaction(PCR) for a better, appreciation of the efficacy of Benzimidazole.
three weeks to six weeks
Assessment of cure rate
Time Frame: three weeks to six weeks
The assessment of efficacy as a cure rate, based on the absence of eggs at three and six weeks post treatment, using microscopy and PRC examination.
three weeks to six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The assessment of safety
Time Frame: three to six weeks.
The adverse events due to a drug intake and the frequency of single nucleotide polymorphisms (SNPs) before and after treatment in each group.The safety of administration of Benzimidazole will be evaluated primarily clinically. The safety will be evaluated within 24 hours and at any unscheduled visit or at week 3 and week 6 to record any symptoms that occur after the drug has been administered.
three to six weeks.

Collaborators and Investigators

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

Sponsor

Centre de Recherche Médicale de Lambaréné

Investigators

  • Principal Investigator: Ayôla Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné

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 (Actual)

November 11, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0084/2019/PR/SG/CNER
  • CEI- 007/2019 (Other Identifier: Institutional ethics committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The Data will be shared in RedCap database.

IPD Sharing Time Frame

The date will be available around December 2020 until september 2021.

IPD Sharing Access Criteria

The Data will be shared12 months after study completion in research journal. A lle the result will be publicly available the

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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