Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura (MOXIDOSE)
Trichuris Trichiura; Infection
About this trial
This is an interventional treatment trial for Trichuris Trichiura; Infection
Eligibility Criteria
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
Sites / Locations
- Public Health Laboratory Ivo de Carneri, P.O. Box 122
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Moxidectin 8 mg
Moxidectin 8 mg + Albendazole
Moxidectin 16 mg
Moxidectin 16 mg + Albendazole
Moxidectin 24 mg
Moxidectin 24 mg + Albendazole
Placebo
A single tablet of 8 mg of moxidectin
A single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg)
Two tablets of 8 mg of moxidectin ( = 16 mg)
Two tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg)
Three tablets of 8 mg of moxidectin ( = 24 mg)
Three tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg)
A single tablet of placebo