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

Swiss Tropical and Public Health (TPH) Institute

Status and phase: Completed; Phase 2

Conditions: Trichuris Trichiura; Infection

Treatments: Drug: Moxidectin 24 mg; Drug: Moxidectin 16 mg + albendazole 400 mg; Drug: Moxidectin 8 mg + albendazole 400 mg; Drug: Moxidectin 16 mg; Drug: Moxidectin 8mg; Drug: Moxidectin 24 mg + albendazole 400 mg; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03501251

MOXI_DOSE_PEMBA

Details and patient eligibility

About

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.

Enrollment: 286 patients

Sex: All

Ages: 16 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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286 participants in 7 patient groups, including a placebo group

Moxidectin 8 mg

Experimental group

Description:

A single tablet of 8 mg of moxidectin

Treatment:

Drug: Moxidectin 8mg

Moxidectin 8 mg + Albendazole

Experimental group

Description:

A single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg)

Treatment:

Drug: Moxidectin 8 mg + albendazole 400 mg

Moxidectin 16 mg

Experimental group

Description:

Two tablets of 8 mg of moxidectin ( = 16 mg)

Treatment:

Drug: Moxidectin 16 mg

Moxidectin 16 mg + Albendazole

Experimental group

Description:

Two tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg)

Treatment:

Drug: Moxidectin 16 mg + albendazole 400 mg

Moxidectin 24 mg

Experimental group

Description:

Three tablets of 8 mg of moxidectin ( = 24 mg)

Treatment:

Drug: Moxidectin 24 mg

Moxidectin 24 mg + Albendazole

Experimental group

Description:

Three tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg)

Treatment:

Drug: Moxidectin 24 mg + albendazole 400 mg

Placebo

Placebo Comparator group

Description:

A single tablet of placebo

Treatment:

Other: Placebo