Condition category
Infections and Infestations
Date applied
20/12/2017
Date assigned
18/01/2018
Last edited
18/01/2018
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 a parasitic worm that lives in fresh water in tropical and subtropical areas. The parasite can infect both humans and fresh water snails. In Côte d’Ivoire, schistosomiasis is endemic (regularly found) and the national control strategy emphasizes preventive chemotherapy (medication). However, this strategy does not protect patients from being infected again and so additional control measures are needed. The aim of this study is to explore the association between the snails that carry schistosomiasis, freshwater prawns that might act as their natural predators, and schistosomiasis among school-aged children and adults.

Who can participate?
Children aged 9–12 and adults aged 20–55 who live in participating villages in Côte d’Ivoire

What does the study involve?
All human-water contact points are visited four times over a 14-month period once every season in each of the 24 villages, in order to collect samples of snails and prawns. Participants give stool and urine samples which are checked for schistosomiasis parasite eggs.

What are the possible benefits and risks of participating?
Participants who are found to be infected are treated with the drug praziquantel. Villages where the prevalence of schistosomiasis is over 20% are all treated with praziquantel by the national schistosomiasis control programme. Praziquantel has few adverse events (e.g. mild abdominal pain and headache).

Where is the study run from?
1. Swiss Tropical and Public Health Institute (Switzerland)
2. Université Félix Houphouët-Boigny (Côte d’Ivoire)

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

Who is funding the study?
The Bill & Melinda Gates Foundation through the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) based at the University of Georgia

Who is the main contact?
Prof. Juerg Utzinger

Trial website

https://score.uga.edu/

Contact information

Type

Scientific

Primary contact

Prof Jürg Utzinger

ORCID ID

http://orcid.org/0000-0001-6885-0798

Contact details

Socinstrasse 57
Basel
4002
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Relationship between native riverine prawns, intermediate host snails and schistosomiasis prevalence in two river systems in Côte d’Ivoire

Acronym

Study hypothesis

Native riverine prawns (Macrobrachium) act as natural predators of schistosomiasis intermediate host snails (Bulinus sp and Biomphalaria), and hence influence the transmission of schistosomiasis.

Ethics approval

Comité National d’Éthique et de la Recherche, Ministère de la Santé et de Lutte contre le SIDA, 22/01/2015, ref: 114/MSLS/CNER-dkn

Study design

Ecological study, including a single cross-sectional parasitological survey in humans and four cross-sectional surveys pertaining to prawns and snails

Primary study design

Observational

Secondary study design

Ecological study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Schistosoma mansoni infection, Schistosoma haematobium infection

Intervention

Twenty-four villages located in two hydrological systems of Côte d’Ivoire will be the selected for the current study. The villages will be situated within a 3 km radius from the main river in the two hydrological system. The villages will be separated from each other by at least 5 km. All human-water contact points will be visited four times over a 14 months study period, once every season in each of the 24 localities. Intermediate host snails will be sampled by two experienced malacologists during 15 min using kitchen sieves and forceps. Prawns will be collected using an electric fishing device. A total of 150 individuals (100 pupils aged 9–12 years and 50 adults aged 20–55 years) will be invited to give stool and urine samples during a single cross sectional survey. Stool samples will be subjected to duplicate Kato-Katz thick smear, and slides quantitatively examined under microscope for Schistosoma mansoni eggs and urine filtration method for to determine Schistosoma haematobium eggs.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Schistosoma mansoni and S. haematobium infection status, assessed with the Kato-Katz and urine filtration methods, respectively, in a cross-sectional survey conducted from 21/01/2016 to 29/01/2016

Secondary outcome measures

1. The presence and number of riverine prawns, collected using an electric fishing device, determined in four surveys once every season:
01/10/2015-12/10/2015
07/04/2016-19/04/2016
19/07/2016-31/07/2016
04/12/2016-15/12/2016
2. The presence and number of intermediate host snails, sampled using kitchen sieves and forceps, determined in four surveys once every season:
01/10/2015-12/10/2015
07/04/2016-19/04/2016
19/07/2016-31/07/2016
04/12/2016-15/12/2016

Overall trial start date

28/05/2015

Overall trial end date

15/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent signed by adults (aged 20-55 years) and parents/guardian of children (aged 9-12 years) and oral assent by children
2. Able and willing to provide a single urine sample at the baseline cross-sectional survey
3. No known allergy to study medication (i.e. praziquantel)

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

3600

Participant exclusion criteria

1. No written informed consent by adults and parents/guardian on behalf of their children
2. Recent use of anthelminthic drug (within past 4 weeks)

Recruitment start date

21/01/2016

Recruitment end date

29/01/2016

Locations

Countries of recruitment

Cote d'Ivoire

Trial participating centre

Swiss Tropical and Public Health Institute
Socinstrasse 57
Basel
4051
Switzerland

Trial participating centre

Université Félix Houphouët-Boigny
Unité de Formation et de Recherche Biosciences 22 BP 770
Abidjan
22
Cote d'Ivoire

Sponsor information

Organisation

Swiss Tropical and Public Health Institute

Sponsor details

Socinstrasse 57
Basel
4051
Switzerland

Sponsor type

Research organisation

Website

https://www.swisstph.ch/en/

Funders

Funder type

Charity

Funder name

The Bill & Melinda Gates Foundation through the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) based at the University of Georgia (sub-awards no. RR374-053/4787986)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol has not yet been published but will be submitted to BMC Public Health and available online in the next few months. The trialists intend to publish the study results in the peer-reviewed (whenever possible open-access) literature before the end of 2018.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes