Clinical trial NCT03261596: Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hookworm Infections
Keywords: Soil-transmitted helminth
hookworm
hookworm infections
necator americanus
ancylostoma duodenale
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Yale University
name: Noguchi Memorial Institute for Medical Research
name: Ghana Health Services
name: HopeXchange Medical Center, Ghana
name: Kintampo Health Research Centre, Ghana
First posted: 2017-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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 criteria: Inclusion Criteria

All participants must meet all of the following 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

Participants must meet none of the following exclusion criteria to be eligible for this study:

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.

Primary outcomes:
measure: Cure Rate (CR) against hookworm, as determined by Kato Katz.
timeFrame: 20 days
Secondary outcomes:
measure: Egg reduction rate (ERR), based on geometric mean, against hookworm
timeFrame: 20 days
measure: CR and ERR against Ascaris lumbricoides and Trichuris trichiura
timeFrame: 20 days
measure: Adverse Events
timeFrame: Through 20 days of follow-up
Other outcomes:
measure: Sensitivity of Kato-Katz and PCR for hookworm infection detection
timeFrame: Up to 14 weeks following Day 20
measure: Prevalence of hookworm genetic resistance markers
timeFrame: Up to 14 weeks following Day 20
measure: Distribution of hookworm species among participants
timeFrame: Up to 14 weeks following Day 20
Locations:
city: Legon
country: Ghana
facility: Noguchi Memorial Institute for Medical Research - University of Ghana
state: Accra
Study officials:
affiliation: Yale University
name: Michael Cappello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ghana
name: Michael Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References: