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

• Status: Completed
• Trial end date: 2018-08-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Tropical & Public Health Institute
• Collaborator: Public Health Laboratory Ivo de Carneri
• Treatments: Albendazole; Milbemycin; Moxidectin

Criteria

Inclusion Criteria:

1. Male and female subjects aged 16 to 18 years, inclusive

2. Written informed consent/assent signed from parent/guardian

3. 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)

4. 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:

1. Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.

2. Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.

3. Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration.

4. Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.

5. Known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.

6. Pregnant (urine testing) or breastfeeding women