Condition category
Infections and Infestations
Date applied
24/02/2017
Date assigned
28/02/2017
Last edited
19/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parasitic worms are organisms that live in the intestine and feed off their living hosts. They are among the most common type of infections worldwide, especially in poor and deprived communities. They are spread by eggs present in human faeces which in turn contaminate soil in areas where sanitation is poor. An infection can cause malnutrition, physical and mental retardation, and reduced work performance in older age. On Pemba Island most children are infected with one or even two or three different types of parasitic worms, despite the fact that preventive treatment with anti-parasite medications such as praziquantel and albendazole is carried out yearly. The existing drugs albendazole and mebendazole, which are widely used in preventive drug treatment, have been found to be ineffective against whipworm (a type of parasitic worm) infections. Therefore there is a need to discover and develop treatment alternatives. Moxidectin is a drug which kills parasitic worms and is used to prevent and control heartworm and intestinal worms in animals. It is currently under approval for use in humans. The aim of this study is to look at the efficacy and safety of moxidectin alone and in combination against parasitic worm infections.

Who can participate?
Patients aged 12-18 years who have parasitic worms.

What does the study involve?
Participants are randomly allocated to one of four groups. Those in the first group receive a single dose of moxidectin to take by mouth, those in the second group are given a single dose of moxidectin and tribendimidine, those in the third group are given a single dose of moxidectin and albendazole and those in the fourth group are given a single dose of albendazole and oxantel pamoate. For all participants, two stool samples are collected if possible on two consecutive days or otherwise within a maximum of 5 days. The medical history of the participants is assessed with a standardized and previously used questionnaire, in addition to a clinical examination carried out by the study physician on the treatment day. Participants are also interviewed before treatment, 1, 3, 24 and 48 hours after treatment about the occurrence of side effects. The efficacy of the treatment is determined 21 days post-treatment by collecting other two stool samples and testing for the presence of parasitic worm eggs.

What are the possible benefits and risks of participating?
Participants benefit from receiving free treatment which could rid them of their parasitic worm infection. The drugs used are safe and have been already used in previous trials with adolescents of the same age range. Participants take the risk of having side effects, but will be closely monitored shortly after assumption and for the following two days.

Where is the study run from?
Public Health Laboratory Ivo de Carneri (Tanzania)

When is the study starting and how long is it expected to run for?
May 2016 to December 2017

Who is funding the study?
Thrasher Foundation (USA)

Who is the main contact?
Professor Jennifer Keiser
jennifer.keiser@unibas.ch

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Keiser

ORCID ID

Contact details

Swiss Tropical and Public Health Institute
Socinstrasse 57
Basel
4051
Switzerland
+41 61 284 82 18
jennifer.keiser@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V 0.1

Study information

Scientific title

Efficacy and safety of moxidectin plus albendazole, moxidectin plus tribendimidine, and moxidectin alone versus albendazole plus oxantel pamoate against Trichuris trichiura and concomitant soil-transmitted helminth infections: a randomised controlled trial

Acronym

Study hypothesis

A combination of moxidectin with albendazole or tribendimidine demonstrates high efficacy against Trichuris trichiura and concomitant soil-transmitted helminth infections.

Ethics approval

1. Ethics committee of Northwestern and Central Switzerland (EKNZ), 21/02/2017, ref: 2016-00839
2. Zanzibar Medical Research and Ethical Committee (Tanzania), ref: ZAMREC/0001/February 2017

Study design

Single-blind randomosed controlled drug combination trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infection with Trichuris trichiura and other soil-transmitted helminths

Intervention

Study participants eligible for treatment will be randomly assigned to one of the four treatment arms using a computer-generated stratified block randomization code. The random allocation sequence with varying random blocks of seven or fourteen will be provided by a statistician.

Group 1: Participants receive a single oral dose of moxidectin 8 mg
Group 2: Participants receive a single oral dose of moxidectin 8 mg plus tribendimidine 400 mg
Group 3: Participants receive a single oral dose of moxidectin 8 mg plus albendazole 400 mg
Group 4: Participants receive a single oral dose of albendazole 400 mg plus oxantel pamoate 25 mg/kg

The treatment will be administered on one day only and follow up will be conducted for all treatment arms 21 days after treatment.

Intervention type

Drug

Phase

Phase II

Drug names

1. Moxidectin 8 mg
2. Tribendimidine 400 mg
3. Albendazole 400 mg
4. Oxantel pamoate 25 mg/kg

Primary outcome measures

The egg reduction rates (ERRs) of moxidectin and the combinations moxidectin/tribendimidine and moxidectin/albendazole against T. trichiura will be assessed using the quadruple Kato-Katz method 21 days after treatment.

Secondary outcome measures

1. Efficacy in terms of CR against T. trichiura and CR and ERR against co-infections using the quadruple Kato-Katz method 21 days after treatment
2. Safety will be assessed with evaluation of the treated subjects at 3, 24 and 48 hours after treatment

Overall trial start date

01/05/2016

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent signed by participants (if 18 years old), parents and/or legal guardian; and oral assent by participants
2. Able and willing to be examined by a study physician at the beginning of the study
3. Able and willing to provide two stool samples, at the beginning (baseline) and approximately one and three weeks after treatment (follow-up)
4. Positive for T. trichiura eggs in the stool
5. Absence of major systemic illnesses (e.g. cancer, diabetes, clinical malaria or organ failure) as assessed by a medical doctor, upon initial clinical assessment
6. No known or reported history of chronic illness as cancer, diabetes, chronic heart, liver or renal disease.
7. No recent anthelminthic treatments (within past 2 months)
8. No known allergy to study medications
9. Age 12-18 years

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

640

Participant exclusion criteria

1. No written informed consent by participants, parents and/or legal guardian
2. Presence of any abnormal medical condition judged by the study physician
3. History of acute or severe chronic disease such as cancer, diabetes, chronic heart, liver or renal disease
4. Recent use of anthelminthic drugs (within past 2 months)
5. Attending other clinical trials during the study
6. Negative diagnostic result for T. trichiura eggs in stool samples
7. Age below 12 years

Recruitment start date

15/03/2017

Recruitment end date

01/11/2017

Locations

Countries of recruitment

Tanzania

Trial participating centre

Public Health Laboratory Ivo de Carneri
P.O. Box 122 Wawi, Chake Chake Pemba, Zanzibar (Tanzania)
Chake Chake
122
Tanzania

Sponsor information

Organisation

Swiss Tropical and Public Health Institute

Sponsor details

Socinstrasse 57
Basel
4051
Switzerland

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Thrasher Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The final results of this study will be shared with the local laboratory staff and later published in a scientific journal and presented at scientific conferences. The outcome of this study will be presented to the MoH of Zanzibar. In addition results from this trial will provide valuable information to the scientific community and to WHO to refine the PC strategy and the use of anthelminthic drugs in combinations. All results from this investigation are considered confidential and shall not be made available to any third part by any member of the investigating team before publication.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Jennifer Keiser (jennifer.keiser@unibas.ch)

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes