Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana

NCT03261596 | Withdrawn Phase 4 DMC

• 1 other identifier: STH-MBZ-PO-4 02-GHA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hookworm Infections

Keywords

Soil-transmitted helminth; hookworm; hookworm infections; necator americanus; ancylostoma duodenale

Outcome Measures

Primary Outcomes (1)

• Cure Rate (CR) against hookworm, as determined by Kato Katz.

  To determine point estimates for the efficacy of two mebendazole regimens: (i) 100 mg solid tablets twice daily for three days, and (ii) single dose of 500 mg solid tablets in participants aged 6 to 18 years infected with hookworm. The CR will be calculated as the percentage of children and adolescents (all hookworm egg-positive at enrollment) who are egg negative 20 days after treatment. The CRs will be tabulated by mebendazole dose regimen received, along with their corresponding 95% CIs.

  20 days

Secondary Outcomes (3)

• Egg reduction rate (ERR), based on geometric mean, against hookworm

  20 days

• CR and ERR against Ascaris lumbricoides and Trichuris trichiura

  20 days

• Adverse Events

  Through 20 days of follow-up

Other Outcomes (3)

• Sensitivity of Kato-Katz and PCR for hookworm infection detection

  Up to 14 weeks following Day 20

• Prevalence of hookworm genetic resistance markers

  Up to 14 weeks following Day 20

• Distribution of hookworm species among participants

  Up to 14 weeks following Day 20

Study Arms (2)

100 mg solid tablets 2x/day for 3 days

EXPERIMENTAL

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.

Drug: Mebendazole

Single dose 500 mg solid tablets

EXPERIMENTAL

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.

Drug: Mebendazole

Interventions

Mebendazole 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.

Also known as: Vermox

100 mg solid tablets 2x/day for 3 days; Single dose 500 mg solid tablets

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• PATH: lead
• Yale University: collaborator
• Noguchi Memorial Institute for Medical Research: collaborator
• Ghana Health Services: collaborator
• HopeXchange Medical Center, Ghana: collaborator
• Kintampo Health Research Centre, Ghana: collaborator

Study Sites (1)

Noguchi Memorial Institute for Medical Research - University of Ghana

Legon, Accra, Ghana

Location

MeSH Terms

Conditions

Hookworm Infections; Ancylostomiasis

Interventions

Mebendazole

Condition Hierarchy (Ancestors)

Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Cappello, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Michael Wilson, PhD

  University of Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 25, 2017
• Study Start: September 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

GH (1)