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Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana

NCT ID: NCT03261596

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Hookworm Infections

Keywords

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Soil-transmitted helminth hookworm hookworm infections necator americanus ancylostoma duodenale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a single site Phase 4, open-label, randomized controlled study. Subjects will be randomized 1:1 to one of two treatment allocations: 150 to receive a single dose of 500 mg mebendazole and 150 to receive a multi-dose of 100 mg mebendazole twice a day for three days.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Study drug will be maintained and dispensed to the participant by a qualified un-blinded study staff member and witnessed by another un-blinded study staff member. The blinding of laboratory staff will be maintained throughout the trial until data entry and processing are complete and the data have been verified.

Study Groups

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100 mg solid tablets 2x/day for 3 days

Assess the efficacy (Cure Rate/CR) and safety of 100 mg dose regimen of mebendazole in children aged 6 to 18 years, inclusive, infected with hookworm.

Group Type EXPERIMENTAL

Mebendazole

Intervention Type DRUG

Participants will be randomized using a 1:1 ratio to one of the two arms. Study participants eligible for treatment will be randomly assigned to one of the two treatment arms using a computer-generated stratified block randomization code.

Single dose 500 mg solid tablets

Assess the efficacy (Cure Rate/CR) and safety of 500 mg dose regimen of mebendazole in children aged 6 to 18 years, inclusive, infected with hookworm.

Group Type EXPERIMENTAL

Mebendazole

Intervention Type DRUG

Participants will be randomized using a 1:1 ratio to one of the two arms. Study participants eligible for treatment will be randomly assigned to one of the two treatment arms using a computer-generated stratified block randomization code.

Interventions

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Mebendazole

Participants will be randomized using a 1:1 ratio to one of the two arms. Study participants eligible for treatment will be randomly assigned to one of the two treatment arms using a computer-generated stratified block randomization code.

Intervention Type DRUG

Other Intervention Names

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Vermox

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Noguchi Memorial Institute for Medical Research

OTHER

Sponsor Role collaborator

Ghana Health Services

OTHER_GOV

Sponsor Role collaborator

HopeXchange Medical Center, Ghana

UNKNOWN

Sponsor Role collaborator

Kintampo Health Research Centre, Ghana

OTHER

Sponsor Role collaborator

PATH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Cappello, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Michael Wilson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ghana

Locations

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Noguchi Memorial Institute for Medical Research - University of Ghana

Legon, Accra, Ghana

Site Status

Countries

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Ghana

Other Identifiers

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STH-MBZ-PO-4 02-GHA

Identifier Type: -

Identifier Source: org_study_id