Condition category
Infections and Infestations
Date applied
25/10/2012
Date assigned
19/11/2012
Last edited
14/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Millions of people in the developing world are at risk of parasitic diseases such as malaria and the so-called neglected tropical diseases (NTDs). The latter include, among others, parasitic worm (helminth) infections, such as soil-transmitted helminthiasis and schistosomiasis. There is a lack of studies investigating the effects of infection with multiple parasites (polyparasitism). Due to the long-lasting and un-specific nature of the symptoms, the public health burden can be greatly underestimated. Given that helminth and schistosomiasis infections cause malnutrition and anemia in school-aged children, it is also possible that they reduce their physical fitness, strength and school performance. The main aims of this study is to determine whether polyparasitic infections including soil-transmitted helminths and schistosomiasis have negative consequences on the physical fitness, strength and cognitive abilities of school-aged children in south-central Côte d’Ivoire, and if treatment against these diseases improves performance in infected children.

Who can participate?
All primary school children from grade 3-6 (age range: 8-15 years) will be invited to participate in this study.

What does the study involve?
The children will submit a stool, urine and finger-prick blood sample, and complete physical and cognitive tests and clinical examinations. All study participants will be treated against soil-transmitted helminths and schistosomiasis with a single dose of albendazole and praziquantel at the start of the study and 2 months and 5 months later. Further tests will take place at the end of the study follow-up, 7 months after the start of the study.

What are the possible benefits and risks of participating?
All participating children will benefit from repeated de-worming with albendazole and praziquantel free of charge. Both treatments are shown to be highly effective against the common soil-transmitted helminths and schistosomiasis, respectively, and have good safety profiles. Treatment will also be offered for children with malaria or severely anaemia.

Where is the study run from?
The study will be conducted in a rural primary school in Agboville department, Agnéby region, Côte d’Ivoire.

When is the study starting and how long is it expected to run for?
The study will start in November 2012 and will run for about 7 months.

Who is funding the study?
Swiss National Science Foundation (SNSF).

Who is the main contact?
Prof. Dr Jürg Utzinger
juerg.utzinger@unibas.ch

Trial website

Contact information

Type

Scientific

Primary contact

Prof Juerg Utzinger

ORCID ID

Contact details

Swiss Tropical and Public Health Institute
Socinstrasse 57
Basel
4002
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Impact on physical fitness and cognitive ability in school children from southern Côte d'Ivoire after treatment against soil-transmitted helminths and schistosomiasis

Acronym

Study hypothesis

Treatment against soil-transmitted helminths and schistosomiasis can improve the physical fitness, strength and school performance of school-aged children.

Ethics approval

1. Ethikkommission beider Basel, Switzerland, 14/04/2011, ref: 30/11 (amendment, 21/06/2011)
2. Comité National d'Ethique et de la Recherche, Côte d'Ivoire, 03/01/2011, ref: 09-2011/MSHP/CNER-P

Study design

Intervention study with cross-sectional assessment

Primary study design

Interventional

Secondary study design

Cross-section survey

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Neglected tropical diseases (soil-transmitted helminth and schistosomiasis infections) and malaria

Intervention

All participants of the study will be treated against soil-transmitted helminths and schistosomiasis with a single dose of albendazole (400 mg) and praziquantel (40 mg/kg), respectively, at baseline, 2 month, 5 months and 7 months (follow-up assessment) after launch of the study.

Intervention type

Drug

Phase

Not Applicable

Drug names

Albendazole, praziquantel

Primary outcome measures

Differences (non-infected vs. infected) and changes (before and after treatment) in physical fitness, strength and cognitive ability

Secondary outcome measures

1. Reduction of infection prevalence and intensity of soil-transmitted helminths and schistosomiasis
2. Differences and changes in disease-related morbidity measures (malnutrition, anemia, organomegaly)

Overall trial start date

01/11/2012

Overall trial end date

01/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary school child, aged 8-15 years, male or female
2. Written informed consent by a parent/guardian on behalf of the child
3. Submission of 1 urine, 1 stool and 1 finger-prick blood sample at baseline
4. Completion of clinical, anthropometric and haemoglobin measurements at baseline
5. Completion of 20 m shuttle run test at baseline
6. Completion of grip strength test and standing broad jump test at baseline
7. Completion of cognitive testing
8. Absence of difficult health condition (clinical malaria, severe anemia, respiratory disease or other major illnesses) as assessed by a medical doctor at baseline
9. No known or reported drug allergy to albendazole or praziquantel
10. Treatment with albendazole and praziquantel

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Approximately 300

Participant exclusion criteria

1. Children below the age of 8 years or above 15 years
2. No written informed consent
3. No complete set of urine, stool and blood sample submitted at baseline
4. Presence of medical condition that prevents child from completing the physical fitness and strength tests
5. Known or reported drug allergy to albendazole or praziquantel
6. Absence/refusal of albendazole and/or praziquantel treatment
7. Attending other clinical trials during the study period

Recruitment start date

01/11/2012

Recruitment end date

01/06/2013

Locations

Countries of recruitment

Cote d'Ivoire

Trial participating centre

Swiss Tropical and Public Health Institute
Basel
4002
Switzerland

Sponsor information

Organisation

Swiss Tropical and Public Health Institute (Switzerland)

Sponsor details

Socinstrasse 57
Basel
4002
Switzerland

Sponsor type

Research organisation

Website

http://www.swisstph.ch/

Funders

Funder type

Government

Funder name

Swiss National Science Foundation [SNSF] (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes