Loading clinical trials...

Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana | Clinical Trials | Clareo Health

WITHDRAWNPHASE4

Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana

Efficacy and Safety of a Single-dose Regimen and a Multi-dose Regimen of Mebendazole Against Hookworm Infections in Children and Adolescents in Ghana: a Randomized Controlled Trial

NCT03261596•PATH

View on ClinicalTrials.gov

Summary

The Ghana study will hypothesize that both the multiple dose and single dose of mebendazole will achieve effective cure rates against hookworm among children and adolescents. This study is intended to be a pilot study for a planned Phase 3 registration trial of a new drug for hookworm, tribendimidine.

Detailed Description

This study will determine the Cure Rates (CRs) of mebendazole regimens to be used as comparator drug regimens in the future pivotal trial of tribendimidine and will provide evidence of the efficacy and safety of mebendazole among children and adolescents infected with hookworm in Ghana. Children and adolescents bear a large burden of morbidity from hookworm infection, so building the evidence base for effective treatments in this population has important public health implications in Ghana and other endemic settings.

Eligibility

Age

6 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, aged 6 to 18 years, inclusive, at the time of randomization.
•2. Written informed consent signed by at least one parent and/or legally acceptable representative (as defined by local law); and assent by participant.
•3. Able and willing to be examined by a study health care provider at the beginning of the study.
•4. Able and willing to provide one stool sample at the beginning (baseline) and one sample approximately three weeks after treatment (follow-up).
•5. Positive for hookworm eggs in the stool (two Kato-Katz thick smear slides with more than one hookworm egg) at baseline.

Exclusion Criteria

•1. Presence of major systemic illnesses as assessed by a study health care provider, upon initial targeted clinical assessment.
•2. Pregnancy, based on a positive urine rapid test, or breastfeeding in girls after menarche.
•3. Recent use of an anthelminthic drug (within the past 4 weeks) or use of anthelminthics not provided by study staff during the study period.
•4. Known allergy to mebendazole or albendazole.
•5. Participation in other clinical trials during the study.

Locations (1)

Noguchi Memorial Institute for Medical Research - University of Ghana

Legon, Accra, Ghana

Key Dates

Start Date

September 1, 2017

Primary Completion Date

December 1, 2017

Completion Date

December 1, 2017

Last Updated

November 17, 2017

Conditions

Hookworm Infections

Interventions

Mebendazole

DRUG

Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

NCT05538767

Hookworm Infections

View study

COMPLETEDPHASE2

Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

NCT03995680

Hookworm Infections

View study

UNKNOWNNA

Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education

NCT04227834

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions