Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: A Small-scale Public Health Intervention Study
NCT ID: NCT06698510
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
18500 participants
OBSERVATIONAL
2024-11-25
2026-03-31
Brief Summary
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The aim of the small-scale pilot study is to assess the performance of different platforms for distributing arPZQ, a child-friendly formulation of praziquantel, to the target population (i.e., preschool-aged children (PSAC)) currently missed out in schistosomiasis treatment campaigns.
The specific objectives of the pilot study are:
* To assess the performance of different platforms for delivery of arPZQ to PSAC aged 24 to 59 months in terms of coverage, feasibility and acceptability
* To determine social mobilization and training needs for effective delivery of arPZQ through different platforms
Preventive chemotherapy with arPZQ will be offered systematically to eligible PSAC aged 2 to below 5 years of consenting caregivers resident in the study area and reached through the selected platforms. Adverse events during MDA with arPZQ will be documented and reported by using existing tools and established reporting pathways aligned with standard pharmacovigilance and safety guidelines of the national drug authorities. Based on routine program processes and forms, variables pertaining to drug logistics, training, drug distribution, passive pharmacovigilance and supervision will be collected in order to measure and generate real-world data related to feasibility, coverage and acceptability of selected platforms and strategies to inform future scale-up to district levels.
Assessments will take place before (to capture social mobilization and training activities) during and after the drug distribution to document the implementation process and evaluate experiences made by the different stakeholders (e.g. children, parents, community members, health workers, programme staff).
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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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arPZQ distributed through Platform 1 (NTD programmes)
Preschool-aged children (24 to 59 months of age) of villages preselected to receive a single oral dose of 50mg/kg or 60mg/kg (depending on country) arpraziquantel as part of the routine schistosomiasis mass drug administration campaigns led by the national NTD programmes.
Arpraziquantel 150mg dispersible tablet
Arpraziquantel 150mg dispersible tablets given as single oral dose of 50mg/kg (in Kenya and Uganda; for Schistosoma mansoni infection) or 60mg/kg (in Côte d'Ivoire; for mixed infections with S. mansoni / S. haematobium) using weight-based dosing tables as detailed in the summary of product characteristics.
arPZQ distributed through Platform 2 (child health days/nutrition programmes)
Preschool-aged children (24 to 59 months of age) of villages preselected to receive a single oral dose of 50mg/kg or 60mg/kg (depending on country) arpraziquantel as part of the routine vitamin A distribution/child health days campaigns led by the national nutrition programmes.
Arpraziquantel 150mg dispersible tablet
Arpraziquantel 150mg dispersible tablets given as single oral dose of 50mg/kg (in Kenya and Uganda; for Schistosoma mansoni infection) or 60mg/kg (in Côte d'Ivoire; for mixed infections with S. mansoni / S. haematobium) using weight-based dosing tables as detailed in the summary of product characteristics.
Interventions
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Arpraziquantel 150mg dispersible tablet
Arpraziquantel 150mg dispersible tablets given as single oral dose of 50mg/kg (in Kenya and Uganda; for Schistosoma mansoni infection) or 60mg/kg (in Côte d'Ivoire; for mixed infections with S. mansoni / S. haematobium) using weight-based dosing tables as detailed in the summary of product characteristics.
Eligibility Criteria
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Inclusion Criteria
* Aged between 24 - 59 months
* Informed consent available
* No acute or chronic illness and/or inability to take oral medication
* No reported history of seizures
* No known allergic response to praziquantel
24 Months
59 Months
ALL
Yes
Sponsors
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Technical University Munchen
UNKNOWN
Makerere University
OTHER
African Institute for Health and Development, Kenya
UNKNOWN
Kenya Medical Research Institute
OTHER
Kenya Ministry of Health
OTHER_GOV
Ministry of Health, Uganda
OTHER_GOV
Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle
UNKNOWN
Université Félix Hophouët-Boigny
UNKNOWN
Unlimit Health
UNKNOWN
Peter Steinmann
OTHER
Responsible Party
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Peter Steinmann
Unit Head
Principal Investigators
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Peter Steinmann, PhD PD
Role: PRINCIPAL_INVESTIGATOR
Swiss Tropical & Public Health Institute
Locations
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Programme National de Lutte Contre les Maladies Tropicales Négligées à Chimiothérapie Préventive (PNLMTN-CP), Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle (MSHPCMU)
Abidjan, , Côte d’Ivoire
Université Félix Hophouët-Boigny (UFHB), Département de sociologie
Abidjan, , Côte d’Ivoire
Université Félix Hophouët-Boigny (UFHB), UFR Biosciences
Abidjan, , Côte d’Ivoire
African Institute for Health and Development (AIHD)
Nairobi, , Kenya
Kenya Medical Research Institute (KEMRI), Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC)
Nairobi, , Kenya
Makerere University, Department of Sociology and Anthropology
Kampala, , Uganda
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Kampala, , Uganda
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RIA2019IR-2895; G2020-102
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2108p
Identifier Type: -
Identifier Source: org_study_id
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