Condition category
Infections and Infestations
Date applied
27/04/2015
Date assigned
19/07/2015
Last edited
07/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Schistosomiasis is an infection caused by parasites that live in fresh water in subtropical and tropical regions of the world. There are six species of schistosomes; S. mansoni, S. japonicum and S. haematobium are the most common. Each year around 230 million people are infected with schistosomes, and around 11,000 people die from the infection. Schistosomiasis can become a persistent chronic disorder in areas with high infection rates, which results in common disabling complications such as anaemia, stunted growth, slow mental development and decreased fitness. The aim of this study is to test how well 4 different drugs work to cure the infection and reduce the number of schistosomes eggs in an infected person’s body. We will be testing how well moxidectin, Synriam® and a Synriam®-praziquantel combination work against schistosome infections compared to taking praziquantel alone. This study will also be testing how safe the drugs are for school children, how effective moxidectin, Synriam® and Synriam®/praziquantel combination are against possible co-infections (Ascaris lumbricoides, Trichuris trichiura, hookworm, Strongyloides stercoralis) and how effective Synriam® is against malaria infection.

Who can participate?
Children infected with schistosomes.

What does the study involve?
Participants are randomly allocated into one of four groups. Those in group 1 (intervention group) are given the drug moxidectin. Those in group 2 (intervention group) are given the drug Synriam®. Those in group 3 (intervention group) are given the drug combination Synriam® and praziquantel. Those in group 4 (intervention group) are given the drug praziquantel. Participants are asked to give urine and stool samples, and a finger prick blood test at the start of the study, then again 3 and 6 weeks after treatment. The medical history of participants is assessed using a questionnaire, and a clinical examination is carried out by the study physician on the day of treatment. There are interviews before treatment, then 2, 24, 48 and 72 hours after treatment.

What are the possible benefits and risks of participating?
All participants have a free diagnosis for intestinal parasitic infection and malaria infection. All are treated and, if not cured by the drug provided, treated with the currently recommended drug (albendazole and praziquantel and malaria treatment according to local guidelines). Risks are represented by side effects linked to the treatment.

Where is the study run from?
1. Centre Suisse de Recherches Scientifiques (CSRS) (Côte d’Ivoire)
2. University Felix Houphouet Boigny (Université Félix Houphouët Boigny (UFHB)) (Côte d’Ivoire)

When is the study starting and how long is it expected to run for?
May 2015 to October 2015

Who is funding the study?
Rudolf Geigy Foundation (Switzerland)

Who is the main contact?
Prof J Keiser

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Keiser

ORCID ID

Contact details

Socinstrasse 57
Basel
4002
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01

Study information

Scientific title

Assessment of the safety and efficacy of oral Moxidectin, Synriam®, Synriam®-Praziquantel combination versus Praziquantel in school children infected with Schistosoma haematobium and Schistosoma mansoni

Acronym

Study hypothesis

The aim of this study is to assess the efficacy of Moxidectin and Synriam in treating schistosomes.

Ethics approval

1. Nordwest und Zentralschweiz Ethics Committee (Ethikkommission Nordwest und Zentralschweiz EKNZ) ref: EKNZ UBE-15/01, 12/01/2015
2. National Ethics & Research Committee (Comite National d'Ethique et de la Recherche CNER) 16./06/2015

Study design

Randomised controlled phase 2 single blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Schistosomiasis

Intervention

This study has four treatment arms - Two stool samples (study 1), three urine samples (study 2) and one blood finger prick sample will be collected if possible on two consecutive days or otherwise within a maximum of 5 days):
1. Moxidectin 8 mg single dose
2. Synriam® 150 mg (arterolane + 750 piperaquine) for three consecutive days
3. Synriam® 150 mg (arterolane + 750 piperaquine) for three consecutive days + praziquantel 40 mg/kg single dose
4. Praziquantel 40 mg/kg single dose

Intervention type

Drug

Phase

Phase II

Drug names

Moxidectin, Synriam (arterolane + piperaquine), Praziquantel

Primary outcome measures

Efficacy: cure and egg reduction rate of S. mansoni and S. haematobium

Secondary outcome measures

1. Drug safety
2. Cure and egg reduction rate against possible co-infections (Ascaris lumbricoides, Trichuris trichiura, hookworm Strongyloides stercoralis)
3. To determine the efficacy of Synriam® against malaria infection

Overall trial start date

04/05/2015

Overall trial end date

01/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent signed by parents and/or legal guardian, and oral assent by children
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, three urine samples and one finger prick test at baselin and approximately three weeks after treatment (follow-up)
4. Positive for S. mansoni or S. haematobium eggs in the stool and/or in urine
5. Absence of major systemic illnesses (e.g. cancer, diabetes, clinical malaria or hepato-splenic schistosomiasis) as assessed by a medical doctor, upon initial clinical assessment
6. No known or reported history of chronic illness, e.g. cancer, diabetes, chronic heart, liver or renal disease
7. No anthelminthic or antimalarial treatments within past 4 weeks
8. No known allergy to study medications

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. No written informed consent by parents and/or legal guardian
2. Presence of any abnormal medical condition, judged by the study physician.
3. History of acute or severe chronic disease such as cancer, diabetes, chronic heart, liver or renal disease
4. Recent use of anthelminthic or antimalarial drugs (within past 4 weeks)
5. Attending other clinical trials during the study
6. Negative diagnostic result for S. mansoni or S. haematobium (absence of helminth eggs in stool/urine)

Recruitment start date

04/05/2015

Recruitment end date

15/05/2015

Locations

Countries of recruitment

Cote d'Ivoire

Trial participating centre

Centre Suisse de Recherches Scientifiques (CSRS) (Côte d’Ivoire)
Niangon Sud
-
Cote d'Ivoire

Trial participating centre

University Felix Houphouet Boigny (Université Félix Houphouët Boigny (UFHB)) (Côte d’Ivoire)
Abidjan
-
Cote d'Ivoire

Sponsor information

Organisation

Geigy Foundation

Sponsor details

Socinstrasse 59
Basel
4002
Switzerland

Sponsor type

Research organisation

Website

Organisation

European Research Council

Sponsor details

Covent Garden
Place Charles Rogier 16
1210 Saint-Josse-ten-Noode
Brussels
1210
Belgium

Sponsor type

Research council

Website

Funders

Funder type

Research organisation

Funder name

Rudolf Geigy Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

One manuscript will be submitted to a scientific journal by the end of 2015.

Intention to publish date

31/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27636542

Publication citations

Additional files

Editorial Notes

07/10/2016: Publication reference added.