Condition category
Infections and Infestations
Date applied
04/04/2016
Date assigned
04/04/2016
Last edited
04/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Strongyloides stercoralis, commonly referred to as threadworms, is a type of parasitic worm that infects the large intestines. S. stercoralis can cause a range of gastrointestinal (gut) symptoms, including nausea, pain and diarrhoea, and long-term infections can lead to disabling complications such as anaemia, stunted growth and slow mental development. S. stercoralis infections are very common in south East Asia and affect mainly adults. At the moment the most effective drug against the infection is ivermectin (a medication used to treat a range of different parasitic infections). The aim of this study is to find out whether the medication moxidectin (a drug designed specifically to kill parasitic worms) is active against the worm in the human body.

Who can participate?
Adults with a S. stercoralis infection.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive a single dose of 8mg moxidectin. Participants in the second group receive a single dose of 200ug/kg ivermectin. At the start of the study and 21 days after treatment, participants provide stool samples so that the severity of the infection can be measured. Participants are also asked to report any unwanted side-effects from the medications 3, 24, 48 and 72 hours after treatment.

What are the possible benefits and risks of participating?
Participants will benefit from receiving a free medical examination and treatment. There are no risks of participating as the study medications have been used before and no major side effects have been reported.

Where is the study run from?
Local villages in Champasack province (Laos)

When is the study starting and how long is it expected to run for?
December 2015 to June 2016

Who is funding the study?
European Research Council (Belgium)

Who is the main contact?
Professor Jennifer Keiser

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Keiser

ORCID ID

Contact details

Swiss Tropical and Public Health Institute (Swiss TPH)
Socinstr. 57
Basel
4051
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of moxidectin vs ivermectin against Strongyloides stercoralis infections: A randomised parallel trial

Acronym

Study hypothesis

The aim of this study is to assess the first time the efficacy of oral moxidectin against S. stercoralis infection.

Ethics approval

1. Ethical comittee of Northern and Central Switzerland, 07/12/2015, ref: EKNZ UBE-15/103
2. Ministry of Health, National Institute of Public Health, Lao People's Democratic Republic, 11/01/2016, ref: NIOPH/NECHR 075

Study design

Single-blind phase 2 randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel 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

Strongyloides stercoralis infection

Intervention

Subjects will be randomly assigned to one of the two treatment arms.

Group 1: Participants receive a single dose of ivermectin 200 ug/kg.
Group 2: Participants receive a single dose of moxidectin 8 mg.

Follow up will be carried out 21 days after the treatment and involves the provision of two stool samples.

Intervention type

Phase

Drug names

Primary outcome measures

Strongyloides stercoralis infection status is determined 21 days after treatment using the Baermann method in 2 stool samples.

Secondary outcome measures

1. Adverse events are measured through self-reporting 3, 24, 48 and 72 hours after treatment
2. S. stercoralis infection intensity is measured using a larval count in stool samples 21 days after treatment in relation to baseline infection intensity (LRR)
3. O. viverrini and other helminth infection status and intensity is measured using stool samples (Kato Katz method) 21 days after treatment

Overall trial start date

01/12/2015

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Infected with S. stercoralis infection
3. Absence of major systemic illnesses
4. Written informed consent signed

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

120 infected subjects

Participant exclusion criteria

1. Abnormal medical conditions or chronic disease
2. Negative diagnostic result for soil-transmitted helminthes infection
3. No written informed consent
4. Recent anthelminthic treatment (past 2 months)
5. Pregnancy

Recruitment start date

21/04/2016

Recruitment end date

06/05/2016

Locations

Countries of recruitment

Laos

Trial participating centre

National Institute of Public Health
Vientiane
01
Laos

Sponsor information

Organisation

Swiss Tropical and Public Health Institute (Swiss TPH)

Sponsor details

Socinstr. 57
Basel
4051
Switzerland

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

European Research Council

Alternative name(s)

ERC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

30/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes