Efficacy of a moxidectin versus ivermectin in subjects infected by Strongyloides stercoralis

ISRCTN	ISRCTN11983645
DOI	https://doi.org/10.1186/ISRCTN11983645
Protocol serial number	N/A
Sponsor	Swiss Tropical and Public Health Institute (Swiss TPH)
Funder	European Research Council

Submission date: 04/04/2016
Registration date: 04/04/2016
Last edited: 07/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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?
Prof. Jennifer Keiser

Contact information

Prof Jennifer Keiser
Scientific

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

Study information

Primary study design	Interventional
Study design	Single-blind phase 2 randomised parallel trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Efficacy of moxidectin vs ivermectin against Strongyloides stercoralis infections: a randomised parallel trial
Study objectives	The aim of this study is to assess the first time the efficacy of oral moxidectin against S. stercoralis infection.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Moxidectin, ivermectin
Primary outcome measure(s)	Strongyloides stercoralis infection status is determined 21 days after treatment using the Baermann method in 2 stool samples.
Key secondary outcome measure(s)	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
Completion date	30/06/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	21/04/2016
Date of final enrolment	06/05/2016

Locations

Countries of recruitment

Lao People's Democratic Republic

Study participating centre

National Institute of Public Health

Vientiane
01
Lao People's Democratic Republic

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/07/2017		Yes	No
Results article	results from embedded study	26/03/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/02/2019: Publication reference added.
19/10/2017: Publication reference added.
11/08/2017: Internal review.
06/07/2017: Internal review.