Status:
WITHDRAWN
Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana
Lead Sponsor:
PATH
Collaborating Sponsors:
Yale University
Noguchi Memorial Institute for Medical Research
Conditions:
Hookworm Infections
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
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...
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 an...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- All participants must meet all of the following inclusion criteria:
- 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.
- Exclusion Criteria
- Participants must meet none of the following exclusion criteria to be eligible for this study:
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03261596
Start Date
September 1 2017
End Date
December 1 2017
Last Update
November 17 2017
Active Locations (1)
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1
Noguchi Memorial Institute for Medical Research - University of Ghana
Legon, Accra, Ghana