Condition category
Infections and Infestations
Date applied
19/05/2017
Date assigned
19/05/2017
Last edited
06/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
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. 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 measure

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 (if study stopped)

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

Sponsor information

Organisation

Swiss Tropical and Public Health Institute

Sponsor details

Socinstrasse 57
Basel
4051
Switzerland

Sponsor type

Research organisation

Website

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

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29617737

Publication citations

Additional files

Editorial Notes

06/04/2018: Publication reference added.