Condition category
Infections and Infestations
Date applied
19/05/2017
Date assigned
19/05/2017
Last edited
25/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Parasitic worms are organisms that live in the intestine and feed off their living hosts. There are many types of parasitic worms, including the hookworm. 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. Tribendimidine is a broad-spectrum anti-parasitic worm drug which has been developed in China. The aim of this study is to find out the best dose of this drug to give to children with hookworm infections.

Who can participate?
Children aged between six and twelve years who have hookworm eggs in their stool.

What does the study involve?
Participants are randomly allocated to one of five groups. Those in the first group receive a single dose of 100 mg tribendimidine. Those in the second group receive a single dose of 200 mg tribendimidine. Those in the third group receive a split 200 mg tablet of tribendimidine. Those in the next group receive a single dose of a placebo (dummy drug). 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 and 24 hours after treatment about whether they have experienced any side effects.

What are the possible benefits and risks of participating?
All participants benefit from receiving a clinical examination and hookworm infection treatment. STHs. All participating children remaining positive for hookworm at the end of the study will be treated with another medication (according to WHO recommendations). There are no notable risks involved with participating.

Where is the study run from?
Rubino Health Center (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?
European Research Council (Belgium)

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
+41 612 848 218
jennifer.keiser@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v.1.02

Study information

Scientific title

Efficacy and safety of ascending dosages of tribendimidine against hookworm and concomitant soil-transmitted helminth infections in children: a randomized controlled trial

Acronym

Study hypothesis

The aim of this study is to compare the efficacy and safety of three oral tribendimidine dosages (100 mg, 200 mg and 400 mg) versus placebo in school-aged children infected with hookworm and to measure tribendimidine disposition using dried blood spot technology.

Ethics approval

1. Ethics committee of Northwestern and Central Switzerland (EKNZ) 03/04/2017, ref: 2017-00139
2. Ministere de la Sante et de hygiene publique, comite nationa d'ethique de la recherche, 17/04/2017, ref: 053/IMSHP/CNER-kp

Study design

Single blind 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 below to request a patient information sheet

Condition

Hookworm infection

Intervention

Current interventions as of 25/07/2017:
Single, oral tribendimidine 100, 200 and 400 mg and placebo.

Patients will be randomized using block randomization to one of four groups.

Intervention group 1: Participants receive a single dose of oral tribendimidine 100 mg
Intervention group 2: Participants receive a single dose of oral tribendimidine 200 mg
Intervention group 4: Participants receive a single dose of oral tribendimidine 400 mg
Control group: Participants receive a single dose of a placebo

Follow up will be conducted for all treatment arms 21 days after treatment.

Previous interventions:
Single, oral tribendimidine 100, 200 and 400 mg and placebo.

Patients will be randomized using block randomization to one of four groups.

Intervention group 1: Participants receive a single dose of oral tribendimidine 100 mg
Intervention group 2: Participants receive a single dose of oral tribendimidine 200 mg
Intervention group 3: Participants receive a single dose of oral tribendimidine 200 mg split tablet
Intervention group 4: Participants receive a single dose of oral tribendimidine 400 mg
Control group: Participants receive a single dose of a placebo

Follow up will be conducted for all treatment arms 21 days after treatment.

Intervention type

Drug

Phase

Phase II

Drug names

Tribendimidine

Primary outcome measures

Cure rate (conversion from being egg positive pre-treatment to egg negative post-treatment) against hookworm infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment.

Secondary outcome measures

1. Egg reduction rate against hookworm infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment
2. Cure and egg reduction rate against concomitant soil-transmitted helminths 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 and 24 hours after treatment
4. Pharmacokinetic parameters: drug concentrations will be measured with a validated LC/MS method at baseline, 2, 3, 4, 5, 6, 7, 7.5, 8.5 and 24 hours post-dosing

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 parents and/or legal representative; and oral assent by child
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. Positive for hookworm eggs in the stool
5. Absence of major systemic illnesses, e.g. diabetes, severe anemia, clinical malaria as assessed by a medical doctor, upon initial clinical assessment
6. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease
7. No recent anthelminthic treatment (within past 4 weeks)
8. No known allergy to tribendimidine
9. Age range is 6-12 years old

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. No written informed consent by parents and/or legal representative
2. Presence of major systemic illnesses, e.g. diabetes, 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 hookworm 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

Rubino Health Center
Rubino
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

Government

Funder name

European Research Council

Alternative name(s)

ERC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Results and Publications

Publication and dissemination plan

Planned scientific publication in a peer reviewed journal.

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

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

25/07/2017: Target number of participants has been updated from 200 to 160. Interventions have been updated.