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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03261596 |
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Date of registration:
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16/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana
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Scientific title:
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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 |
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Date of first enrolment:
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September 2017 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03261596 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 4
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Michael Wilson, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ghana |
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Name:
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Michael Cappello, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yale University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hookworm Infections
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Intervention(s)
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Drug: Mebendazole
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Primary Outcome(s)
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Cure Rate (CR) against hookworm, as determined by Kato Katz.
[Time Frame: 20 days]
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Secondary Outcome(s)
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CR and ERR against Ascaris lumbricoides and Trichuris trichiura
[Time Frame: 20 days]
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Adverse Events
[Time Frame: Through 20 days of follow-up]
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Egg reduction rate (ERR), based on geometric mean, against hookworm
[Time Frame: 20 days]
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Secondary ID(s)
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STH-MBZ-PO-4 02-GHA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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