Actively Recruiting

Age: 24Months - 59Months
All Genders
Healthy Volunteers
NCT06698510

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

Led by Peter Steinmann · Updated on 2025-09-24

18500

Participants Needed

7

Research Sites

65 weeks

Total Duration

On this page

Sponsors

P

Peter Steinmann

Lead Sponsor

T

Technical University Munchen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 24Months - 59Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Living in the designated implementation area since at least 6 months
  • Aged between 24 - 59 months
  • Informed consent available
Not Eligible

You will not qualify if you...

  • Acute or chronic illness and/or inability to take oral medication
  • Reported history of seizures
  • Known allergic response to praziquantel

AI-Screening

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Trial Site Locations

Total: 7 locations

1

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

Actively Recruiting

2

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

Abidjan, Côte d’Ivoire

Actively Recruiting

3

Université Félix Hophouët-Boigny (UFHB), UFR Biosciences

Abidjan, Côte d’Ivoire

Actively Recruiting

4

African Institute for Health and Development (AIHD)

Nairobi, Kenya

Not Yet Recruiting

5

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

Nairobi, Kenya

Not Yet Recruiting

6

Makerere University, Department of Sociology and Anthropology

Kampala, Uganda

Not Yet Recruiting

7

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

Kampala, Uganda

Not Yet Recruiting

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Research Team

P

Peter Steinmann, PhD PD

CONTACT

N

Nora Monnier, Dr. med.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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