Project Title

Novartis Institute for Biomedical Research (NIBR), Switzerland

EDCTP Project Call

EDCTP Clinical Research & Development Fellowship (R&D F)

Host Organisation

Project Title

Optimization of praziquantel therapy for Schistosoma mansoni infection in preschool-aged children in Ethiopia: PrazOpt

EDCTP Project Call

Career Development Fellowship (CDF)

Project Objectives

Primary Objective: The primary objective of this study is to determine curative rate of praziquantel 40 mg/kg single dose in S. mansoni infection in preschool-aged children. Secondary objectives of this clinical research are to: - Determine egg reduction rate - Assess safety outcomes (adverse events) - Estimate pharmacokinetic parameters - Assess polymorphisms of gene for praziquantel metabolizing enzymes - Identify correlates of curative outcome.

Study Design

This study is a prospective observational study which assesses treatment outcome of S. mansoni infected preschool-aged children who got praziquantel treatment. So, the study doesn’t have any interventions except collection of biological specimen for safety and efficacy evaluations.

Project Summary

Schistosomiasis is a worldwide public health problem, particularly in sub-Saharan Africa where approximately 90% of the infections are found. Schistosomiasis treatment and control relies largely upon therapy with praziquantel directed primarily at school-aged children (SAC) living in schistosomiasis-endemic areas. Even though the occurrence of schistosomiasis within African preschool-aged children (PSAC) has been much better documented in recent years an important burden of disease previously overlooked, only SAC are the principal target group of preventive chemotherapy with praziquantel because of the limited information on efficacy and safety in PSAC and the wrong thought of PSAC to be at low risk of schistosomiasis. A recent study revealed that praziquantel has a flat dose (20-60 mg/kg)-response and overall lower efficacy in PSAC compared with in SAC.The extrapolation of SAC and adult praziquantel dosages to PSAC may not provide good estimates in view of the maturational differences in absorption, metabolism and elimination. The aforementioned findings show the need to have additional studies to generate evidence that is able to provide ultimate dosing recommendations of praziquantel for PSAC, based on inputs from pharmacokinetic, pharmacogenetic data and intensity of S. mansoni infections. To this account, our research team proposes a study titled “Optimization of praziquantel therapy in preschool-aged children infected with S. mansoni: PrazOpt” to be executed with the financial support from EDCTP2 under the scheme of Career Development Fellowship 2018.

Host Organisation

Sites

Current Organisation

Addis Ababa University

Current Job Title

Associate Professor

Biography