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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Other
Study 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Albendazole, praziquantel
Primary outcome measure
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 study start date
01/11/2012
Overall study end date
01/06/2013
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Child
Lower age limit
8 Years
Upper age limit
15 Years
Sex
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, Switzerland
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|