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ISRCTN
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ISRCTN53172722
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ClinicalTrials.gov identifier
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Public title
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Epidemiology and control of schistosomiasis in preschool-aged children in Côte d’Ivoire, with particular consideration to the efficacy and safety of crushed praziquantel tablets
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Scientific title
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Epidemiology and control of schistosomiasis in preschool-aged children in Côte d’Ivoire, with particular consideration to the efficacy and safety of crushed praziquantel tablets: a non-randomised study
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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1. Praziquantel (administered at 40 mg/kg oral dose using crushed tablets) is efficacious against S. mansoni and S. haematobium infections in preschool-aged children
2. Praziquantel treatment in preschool-aged children is safe
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Lay summary
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Lay summary under review
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Ethics approval
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National Research Ethics Committe,Côte d’Ivoire [Comité National d’Ethique et de la Recherche (CNER) in Côte d’Ivoire], 25 August 2010, ref: 4248/2010/MSHP/CNER
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Study design
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Non-randomised interventional study
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Countries of recruitment
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Cote d'Ivoire
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Disease/condition/study domain
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Schistosomiasis
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Participants - inclusion criteria
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1. Both males and females, aged less than or equal to 72 months
2. Written informed consent by parents or legal guardian
3. Submission of two stool samples of sufficient size to prepare duplicate Kato-Katz thick smears from each sample at the baseline survey
4. Submission of two urine samples of sufficient amount for urine filtration method at the baseline survey
5. Provision of single finger-prick blood sample for malaria rapid diagnostic test and haemoglobin level assessment
6. Absence of major systemic illnesses, as assessed by medical personnel on the day of treatment
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Participants - exclusion criteria
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1. Children aged more than 72 months
2. No written informed consent provided by by parents or legal guardian
3. Submission of less than two stool samples of sufficient size to prepare duplicate Kato-Katz smears from each sample at the baseline or follow-up survey
4. Submission of less than two urine samples of sufficient amount for urine filtration method at the baseline survey
5. No provision of finger-prick blood sample for malaria rapid diagnostic test and haemoglobin level assessment
6. Presence of any abnormal medical condition, as judged by the medical personnel on the day of treatment (e.g. clinical malaria)
7. Recent anthelminthic treatment (within 4 weeks)
8. Participation in other studies
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Anticipated start date
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25/08/2011
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Anticipated end date
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15/10/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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350
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Interventions
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Study participants diagnosed with either S. mansoni, or S. haematobium or both species concurrently will be treated with praziquantel (single 40 mg/kg oral dose, using crushed tablets)
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Primary outcome measure(s)
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Cure rate and egg reduction rate of S. mansoni and S. haematobium, determined 3-4 weeks post-treatment by multiple stool sampling using the Kato-Katz method and multiple urine filtration tests
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Secondary outcome measure(s)
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Frequency and severity of adverse events recorded within 24 hours after drug administration
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Sources of funding
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Rudolf Geigy Foundation for the benefit of the Swiss Tropical Institute and Public Health [Rudolf Geigy-Stiftung zu Gunsten des Schweizerischen Tropen- und Public Health-Instituts] (Switzerland)
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Trial website
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Publications
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Contact name
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Prof
Juerg
Utzinger
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Address
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Department of Epidemiology and Public Health
Swiss Tropical and Public Health Institute
Socinstrasse 57
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City/town
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Basel
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Zip/Postcode
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4002
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Country
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Switzerland
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Sponsor
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Swiss Tropical and Public Health Institute (Switzerland)
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Address
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c/o Prof Juerg Utzinger
Department of Epidemiology and Public Health
Socinstrasse 57
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City/town
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Basel
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Zip/Postcode
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4002
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Country
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Switzerland
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Tel
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+41 (0)61 284 8129
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Fax
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+41 (0)61 284 8105
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Email
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juerg.utzinger@unibas.ch
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Sponsor website:
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http://www.swisstph.ch/
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Date applied
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23/08/2011
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Last edited
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07/11/2011
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Date ISRCTN assigned
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07/11/2011
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