WithdrawnPhase 4

Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana

Stopped: In light of new evidence, the decision was made by the sponsor to not proceed.

Ghana0Started 2017-09

Plain-language 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.

Who can participate

Age range6 Years – 18 Years

SexALL

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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

✕. 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.

What they're measuring

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

Timeframe: 20 days

Trial details

NCT IDNCT03261596

SponsorPATH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Hookworm Infections trials