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

August 13, 2018 updated by: Jennifer Keiser, Swiss Tropical & Public Health Institute

Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura in Adolescents: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
    • Pemba
      • Chake Chake, Pemba, Tanzania
        • Public Health Laboratory Ivo de Carneri, P.O. Box 122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Moxidectin 8 mg
A single tablet of 8 mg of moxidectin
Drug: Moxidectin 8mg
Participants will receive the tablet with clean water and a package of biscuits.
EXPERIMENTAL: Moxidectin 8 mg + Albendazole
A single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg)
Drug: Moxidectin 8 mg + albendazole 400 mg
Participants will receive the tablets with clean water and a package of biscuits.
EXPERIMENTAL: Moxidectin 16 mg
Two tablets of 8 mg of moxidectin ( = 16 mg)
Drug: Moxidectin 16 mg
Participants will receive the tablets with clean water and a package of biscuits.
EXPERIMENTAL: Moxidectin 16 mg + Albendazole
Two tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg)
Drug: Moxidectin 16 mg + albendazole 400 mg
Participants will receive the tablets with clean water and a package of biscuits.
EXPERIMENTAL: Moxidectin 24 mg
Three tablets of 8 mg of moxidectin ( = 24 mg)
Drug: Moxidectin 24 mg
Participants will receive the tablets with clean water and a package of biscuits.
EXPERIMENTAL: Moxidectin 24 mg + Albendazole
Three tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg)
Drug: Moxidectin 24 mg + albendazole 400 mg
Participants will receive the tablets with clean water and a package of biscuits.
PLACEBO_COMPARATOR: Placebo
A single tablet of placebo
Other: Placebo
Participants will receive the tablet with clean water and a package of biscuits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate against Trichuris trichiura
Time Frame: 6 weeks
Conversion from being Trichuris trichiura-egg positive pre-treatment to egg negative post-treatment. Since this might be influenced by infection intensity, treatment groups will be equally balanced in terms of infection intensity by 2 levels of baseline infection intensity (light infections and moderate/heavy infections).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Egg Reduction Rate of the different drug regimens against Trichuris trichiura
Time Frame: 6 weeks
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
6 weeks
Cure rate of the different drug regimens against Ascaris lumbricoides
Time Frame: 6 weeks
Conversion from being Ascaris lumbricoides-egg positive pre-treatment to egg negative post-treatment.
6 weeks
Egg Reduction Rate of Ascaris lumbricoides
Time Frame: 6 weeks
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
6 weeks
Cure rate against hookworm
Time Frame: 6 weeks
Conversion from being hookworm-egg positive pre-treatment to egg negative post-treatment.
6 weeks
Egg Reduction Rate of hookworm
Time Frame: 6 weeks
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
6 weeks
Number of adverse events at 5 time points
Time Frame: 6 weeks
Patients will be kept for observation for at least 3 hours following treatment for any acute adverse events. During the reporting period, any unfavorable changes in the subject's condition will be recorded as adverse events, whether reported by the subject or observed by the Investigator. In case of any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. In addition, patients will be also interviewed by a nurse and/or a physician about the occurrence of adverse events 24, 48 and 72 hours post-treatment using a questionnaire. Finally, upon collection of the first follow-up stool sample participants will be re-questioned.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Tropical & Public Health Institute

Collaborators

Public Health Laboratory Ivo de Carneri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 3, 2018

Primary Completion (ACTUAL)

August 11, 2018

Study Completion (ACTUAL)

August 11, 2018

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOXI_DOSE_PEMBA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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