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

Acronym	PrazOpt (Reference Number: TMA2018CDF-2345)
Duration	01/09/2019 - 31/08/2022
Project Topic	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 revealing 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 off-label use of praziquantel at a standard dose of 40 mg/kg to treat PSAC has been initiated because of the experience in SAC and adults. This 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 propose 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. The PrazOpt work package involve the following activities which are relevant to EDCTP2 and the call actions: 1) Conduct observational prospective study to assess cure rate of PSAC having schistosomiasis with 40 mg/kg single dose praziquantel therapy, assess pharmacokinetic of praziquantel, and pharmacogenetic and other biological factors affecting treatment outcome, evaluate the adverse events; 2) Advise one clinical pharmacology PhD student thesis research; 3) Carry out training on GCP, data management, clinical study management, and pharmacokinetic modelling. We believe that the research findings will generate data to suggest optimized praziquantel therapy. In addition, the fellowship scheme will help the applicant Fellow and his postgraduate students to join the team of clinical research consortium with a better capability to host early phase clinical trials investigating innovative or repurposed products for neglected tropical diseases.
Network	EDCTP2
Call	Career Development Fellowships 2018

Project partner

Number	Name	Role	Country
1	Addis Ababa University	Coordinator	Ethiopia