Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: a Small-scale Public Health Intervention Study

Last updated: February 4, 2025
Sponsor: Peter Steinmann
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Arpraziquantel 150mg dispersible tablet

Clinical Study ID

NCT06698510
2108p
RIA2019IR-2895; G2020-102
  • Ages 24-59
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The proposed small-scale pilot studies are public health intervention studies implemented through established routine programs and services in the frame of the mass drug administration (MDA) campaigns in Côte d'Ivoire, Kenya and Uganda. In each country two most promising health intervention platforms were selected for pilot distribution of arpraziquantel 150mg (arPZQ).

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).

Eligibility Criteria

Inclusion

  • Living in the designated implementation area since at least 6 months

  • 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

Study Design

Total Participants: 18500
Treatment Group(s): 1
Primary Treatment: Arpraziquantel 150mg dispersible tablet
Phase:
Study Start date:
November 25, 2024
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • 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

    Active - Recruiting

  • Université Félix Hophouët-Boigny (UFHB), Département de sociologie

    Abidjan,
    Côte D'Ivoire

    Active - Recruiting

  • Université Félix Hophouët-Boigny (UFHB), UFR Biosciences

    Abidjan,
    Côte D'Ivoire

    Active - Recruiting

  • African Institute for Health and Development (AIHD)

    Nairobi,
    Kenya

    Site Not Available

  • Kenya Medical Research Institute (KEMRI), Eastern and Southern Africa Centre of International Parasite Control (ESACIPAC)

    Nairobi,
    Kenya

    Site Not Available

  • Makerere University, Department of Sociology and Anthropology

    Kampala,
    Uganda

    Site Not Available

  • Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health

    Kampala,
    Uganda

    Site Not Available

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