CompletedPhase 2

Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura

Tanzania286 participantsStarted 2018-07-03

Plain-language summary

The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania.

Who can participate

Age range16 Years – 18 Years

SexALL

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Inclusion criteria

✓. Male and female subjects aged 16 to 18 years, inclusive
✓. Written informed consent/assent signed from parent/guardian
✓. Positive for T. trichiura by at least two slides of the quadruple Kato-Katz thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)
✓. Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).

Exclusion criteria

✕. Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
✕. Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
✕. Prior treatment with anthelmintics (eg, diethylcarbamazine \[DEC\], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration.
✕. Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
✕. Known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.
✕. Pregnant (urine testing) or breastfeeding women

What they're measuring

Cure rate against Trichuris trichiura

Timeframe: 6 weeks

Trial details

NCT IDNCT03501251

SponsorSwiss Tropical & Public Health Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-08-11

View on ClinicalTrials.gov More Trichuris Trichiura; Infection trials