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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-03

Study Completion Date

2018-08-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Trichuris Trichiura; Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Participants will receive placebos. Outcome assessors and caregivers will not have access to the list of children allocated to each treatment arm.

Study Groups

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Moxidectin 8 mg

A single tablet of 8 mg of moxidectin

Group Type EXPERIMENTAL

Moxidectin 8mg

Intervention Type DRUG

Participants will receive the tablet with clean water and a package of biscuits.

Moxidectin 8 mg + Albendazole

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

Group Type EXPERIMENTAL

Moxidectin 8 mg + albendazole 400 mg

Intervention Type DRUG

Participants will receive the tablets with clean water and a package of biscuits.

Moxidectin 16 mg

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

Group Type EXPERIMENTAL

Moxidectin 16 mg

Intervention Type DRUG

Participants will receive the tablets with clean water and a package of biscuits.

Moxidectin 16 mg + Albendazole

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

Group Type EXPERIMENTAL

Moxidectin 16 mg + albendazole 400 mg

Intervention Type DRUG

Participants will receive the tablets with clean water and a package of biscuits.

Moxidectin 24 mg

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

Group Type EXPERIMENTAL

Moxidectin 24 mg

Intervention Type DRUG

Participants will receive the tablets with clean water and a package of biscuits.

Moxidectin 24 mg + Albendazole

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

Group Type EXPERIMENTAL

Moxidectin 24 mg + albendazole 400 mg

Intervention Type DRUG

Participants will receive the tablets with clean water and a package of biscuits.

Placebo

A single tablet of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will receive the tablet with clean water and a package of biscuits.

Interventions

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Moxidectin 8mg

Participants will receive the tablet with clean water and a package of biscuits.

Intervention Type DRUG

Moxidectin 8 mg + albendazole 400 mg

Participants will receive the tablets with clean water and a package of biscuits.

Intervention Type DRUG

Moxidectin 16 mg

Participants will receive the tablets with clean water and a package of biscuits.

Intervention Type DRUG

Moxidectin 16 mg + albendazole 400 mg

Participants will receive the tablets with clean water and a package of biscuits.

Intervention Type DRUG

Moxidectin 24 mg

Participants will receive the tablets with clean water and a package of biscuits.

Intervention Type DRUG

Moxidectin 24 mg + albendazole 400 mg

Participants will receive the tablets with clean water and a package of biscuits.

Intervention Type DRUG

Placebo

Participants will receive the tablet with clean water and a package of biscuits.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No