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 (0)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 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
2. Tribendimidine
3. Albendazole
4. Oxantel pamoate
Primary outcome measure
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 (if study stopped)
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
Child
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
PO Box 122 Wawi, Chake Chake
Pemba, Zanzibar (Tanzania)
Chake Chake
122
Tanzania
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
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29858149