Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PATH
• Collaborators: Ghana Health Services; HopeXchange Medical Center, Ghana; Kintampo Health Research Centre, Ghana; Noguchi Memorial Institute for Medical Research; Yale University
• Treatments: DMP 777; Mebendazole; Piperazine; Piperazine citrate

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.