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. Few drugs are available which are widely used in the treatment of parasitic worm infections and drug resistance is a growing problem. Ivermectin (a medication used to treat a range of parasitic worm infections), may be useful when used in combination with other medications. The aim of this study is to find the best dose of ivermectin to use in the treatment of parasitic worm infections.
Who can participate?
Adults, pre-school children and school age children with a parasitic worm infection.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a single dose of a placebo (dummy drug). Those in the second group receive a single dose of ivermectin. The dose will vary depending on the age of the participant. 21 days after receiving the treatment, participants provide a stool sample which is then tested for signs of parasitic worm eggs. Participants are also interviewed before treatment, 3, 24, and 72 hours after treatment about whether they have experienced any side effects.
What are the possible benefits and risks of participating?
All participants will benefit from a clinical examination and a treatment against parasitic worm infections. In addition, all participants who do not respond to treatment will receive treatment with a different drug (according to WHO recommendations). Ivermectin is a well-known, widely used drug and has very few, mild side effects. Therefore there are no significant risks involved with taking part.
Where is the study run from?
Hôpital Méthodiste de Dabou (Cote d’Ivoire)
When is the study starting and how long is it expected to run for?
January 2017 to December 2017
Who is funding the study?
Bill and Melinda Gates 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)612 848 218
jennifer.keiser@unibas.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.02
Study information
Scientific title
Efficacy and safety of ascending dosages of ivermectin against Trichuris trichiura in preschool- and school-aged children: a randomized controlled trial
Acronym
Study hypothesis
Study aims:
1. To determine pharmacokinetic parameters in 10 adult patients infected with T. trichiura using whole blood, plasma, dried blood spots (DBS) and Mitra® allowing the determination of the best microsampling technology.
2. To compare the efficacy and safety of oral ivermectin dosages: i) 100 µg/kg and ii) 200 µg/kg versus iii) placebo in preschoolers infected with T. trichiura and to measure ivermectin disposition using a microsampling technology (DBS or Mitra®).
3. To compare the efficacy and safety of oral ivermectin dosages: i) 200 µg/kg ii) 400 µg/kg and iii) 600 µg/kg versus vi.) placebo in school-aged children infected with T. trichiura and to measure ivermectin disposition using a microsampling technology (DBS or Mitra®).
Ethics approval
1. Ethics committee of Northwestern and Central Switzerland (EKNZ), 20/03/2017, ref: 2017-00250
2. Ministere de la Sante et de l'hygiene publique, comite national d'ethique de la recherche, 17/04/2017, ref: 052/fMSHP/CNER-kp
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Trichuris infection
Intervention
Study participants eligible for treatment will be randomly assigned to receive single, oral doses of placebo or ivermectin using a computer-generated stratified block randomization code. The random allocation sequence with varying random blocks will be provided by a statistician. The following doses of ivermectin will be used:
Adults: 0.2 μg/kg ivermectin
Preschoolers: 0.1 and 0.2 μg/kg ivermectin
School-aged children: 0.2, 0.4 and 0.6 μg/kg ivermectin
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
Ivermectin
Primary outcome measures
Cure rate (CR) (conversion from being egg positive pre-treatment to egg negative post-treatment) for Trichuris infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment.
Secondary outcome measures
1. Egg reduction rate for Trichuris infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment
2. Cure rate and egg reduction rate for concomitant soil-transmitted helminth infections will be assessed using the quadruple Kato-Katz method at 21 days post-treatment
3. Safety will be assessed with evaluation of adverse events of the treated subjects based on interviews at 3, 24, and 72 hours after treatment
4. Pharmacokinetic parameters: drug concentrations will be measured with a validated LC/MS method at baseline, 2, 4, 6, 7, 8, 9, 24, 48 and 72 hours post treatment
Overall trial start date
01/01/2017
Overall trial end date
31/12/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Written informed consent signed by either participating PK patient or for the study involving children parents and/or caregiver; and oral assent by child (aged 6-12 years)
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 three weeks after treatment (follow-up)
4. Corresponding age to be included in the respective age groups of interest (i.e. between 2 to 5 years for preschoolers, between 6 to 12 for school-aged children or ≥21 years for the adult age group sample)
5. Positive for T. trichiura eggs in the stool
6. Absence of major systemic illnesses, e.g. severe anemia, clinical malaria as assessed by a medical doctor, upon initial clinical assessment
7. No known or reported history of chronic illness as cancer, diabetes, chronic heart, liver or renal disease
8. No recent anthelminthic treatment (within past 4 weeks)
9. No known allergy to study medications (i.e., ivermectin)
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
290
Participant exclusion criteria
1. No written informed consent by individual/parents and/or caregiver
2. Presence of major systemic illnesses, e.g. severe anemia, clinical malaria as assessed by a medical doctor, upon initial clinical assessment
3. History of acute or severe chronic disease
4. Recent use of anthelminthic drug (within past 4 weeks)
5. Attending other clinical trials during the study
6. Negative diagnostic result for T. trichiura eggs in the stool
Recruitment start date
25/05/2017
Recruitment end date
30/09/2017
Locations
Countries of recruitment
Cote d'Ivoire
Trial participating centre
Hôpital Méthodiste de Dabou
Dabou
0000
Cote d'Ivoire
Funders
Funder type
Charity
Funder name
Bill and Melinda Gates Foundation
Alternative name(s)
Bill & Melinda Gates Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal mid 2018.
IPD Sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from jennifer.keiser@unibas.ch
Intention to publish date
30/06/2018
Participant level data
Available on request
Results - basic reporting
Publication summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29617737