Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura - Clinical Trial for Trichuris Trichiura; Infection | NCT03501251

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Tanzania

Study Type

Interventional

Intervention

Moxidectin 8mg

Moxidectin 8 mg + albendazole 400 mg

Moxidectin 16 mg

Moxidectin 16 mg + albendazole 400 mg

Moxidectin 24 mg

Moxidectin 24 mg + albendazole 400 mg

Placebo

About this trial

This is an interventional treatment trial for Trichuris Trichiura; Infection

Eligibility Criteria

16 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

Moxidectin 8 mg

Moxidectin 8 mg + Albendazole

Moxidectin 16 mg

Moxidectin 16 mg + Albendazole

Moxidectin 24 mg

Moxidectin 24 mg + Albendazole

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Cure rate against Trichuris trichiura

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).

Secondary Outcome Measures

Egg Reduction Rate of the different drug regimens against Trichuris trichiura

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.

Cure rate of the different drug regimens against Ascaris lumbricoides

Conversion from being Ascaris lumbricoides-egg positive pre-treatment to egg negative post-treatment.

Egg Reduction Rate of Ascaris lumbricoides

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.

Cure rate against hookworm

Conversion from being hookworm-egg positive pre-treatment to egg negative post-treatment.

Egg Reduction Rate of hookworm

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.

Number of adverse events at 5 time points

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.

Full Information

NCT ID

NCT03501251

First Posted

March 1, 2018

Last Updated

August 13, 2018

Sponsor

Swiss Tropical & Public Health Institute

Collaborators

Public Health Laboratory Ivo de Carneri

1. Study Identification

Unique Protocol Identification Number

NCT03501251

Brief Title

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

Acronym

MOXIDOSE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 3, 2018 (Actual)

Primary Completion Date

August 11, 2018 (Actual)

Study Completion Date

August 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Swiss Tropical & Public Health Institute

Collaborators

Public Health Laboratory Ivo de Carneri

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trichuris Trichiura; Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

286 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moxidectin 8 mg

Arm Type

Experimental

Arm Description

A single tablet of 8 mg of moxidectin

Arm Title

Moxidectin 8 mg + Albendazole

Arm Type

Experimental

Arm Description

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

Arm Title

Moxidectin 16 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Moxidectin 16 mg + Albendazole

Arm Type

Experimental

Arm Description

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

Arm Title

Moxidectin 24 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Moxidectin 24 mg + Albendazole

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A single tablet of placebo

Intervention Type

Drug

Intervention Name(s)

Moxidectin 8mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Moxidectin 8 mg + albendazole 400 mg

Intervention Description