Repeated doses of Praziquantel in Schistosomiasis Treatment (RePST) \u2013 single versus multiple praziquantel treatments in school-aged children in C\xf4te d\u2019Ivoire: a study protocol for an open-label, randomised controlled trial

Y K N’Gbesso,P T Hoekstra,M Casacuberta Partal,M Roestenberg,S Tsonaka,J T Coulibaly,K D Silué,J Utzinger,S Knopp,E K N’Goran,A S Amoah,G J Van Dam,L Van Lieshout,P L A M Corstjens,A Meité,R K Assaré

doi:10.1186/s12879-018-3554-2

Y K N’Gbesso, P T Hoekstra + Show 14 more

Open Access

https://doi.org/10.1186/s12879-018-3554-2

Copy DOI

Abstract

BackgroundLarge scale administration of the anthelminthic drug praziquantel (PZQ) to at-risk populations is the cornerstone of schistosomiasis control, although persisting high prevalence of infections in some areas and growing concerns of PZQ resistance have revealed the limitations of this strategy. Most studies assessing PZQ efficacy have used relatively insensitive parasitological diagnostics, such as the Kato-Katz (KK) and urine-filtration methods, thereby overestimating cure rates (CRs). This study aims to determine the efficacy of repeated PZQ treatments against Schistosoma mansoni infection in school-aged children in Côte d’Ivoire using the traditional KK technique, as well as more sensitive antigen- and DNA-detection methods.MethodsAn open-label, randomised controlled trial will be conducted in school-aged children (5 to 18 years) from the region of Taabo, Côte d’Ivoire, an area endemic for S. mansoni. This 8-week trial includes four two-weekly standard doses of PZQ in the “intense treatment” intervention group and one standard dose of PZQ in the “standard treatment” control group. The efficacy of PZQ will be evaluated in stool samples using the KK technique and real-time PCR as well as in urine using the point-of-care circulating cathodic antigen test and the up-converting phosphor, lateral flow, circulating anodic antigen assay. The primary outcome of the study will be the difference in CR of intense versus standard treatment with PZQ on individuals with a confirmed S. mansoni infection measured by KK. Secondary outcomes include the difference in CR and intensity reduction rate between the intense and standard treatment groups as measured by the other diagnostic tests, as well as the accuracy of the different diagnostic tests, and the safety of PZQ.DiscussionThis study will provide data on the efficacy of repeated PZQ treatment on the clearance of S. mansoni as measured by several diagnostic techniques. These findings will inform future mass drug administration policy and shed light on position of novel diagnostic tools to evaluate schistosomiasis control strategies.Trial registrationThe study is registered at EudraCT (2016–003017-10, date of registration: 22 July 2016) and (NCT02868385, date of registration: 16 August 2016).

Highlights

Large scale administration of the anthelminthic drug praziquantel (PZQ) to at-risk populations is the cornerstone of schistosomiasis control, persisting high prevalence of infections in some areas and growing concerns of PZQ resistance have revealed the limitations of this strategy
Large-scale administration of the anthelminthic drug praziquantel (PZQ) to at-risk populations has become the cornerstone of schistosomiasis control [2, 3]
The repeated doses of PZQ in schistosomiasis treatment (RePST) trial is the first and currently the only clinical trial that will investigate the efficacy of four repeated standard doses of PZQ on the clearance of S. mansoni in a randomised trial design

Summary

Introduction

Large scale administration of the anthelminthic drug praziquantel (PZQ) to at-risk populations is the cornerstone of schistosomiasis control, persisting high prevalence of infections in some areas and growing concerns of PZQ resistance have revealed the limitations of this strategy. Large-scale administration of the anthelminthic drug praziquantel (PZQ) to at-risk populations has become the cornerstone of schistosomiasis control [2, 3]. This strategy – known as preventive chemotherapy – has been successful in reducing infection intensities, and morbidity [4, 5]. Mass drug administration (MDA) of preventive chemotherapy targets school-aged children primarily [6, 7] These children are intermittently treated with a single oral dose of 40 mg/kg PZQ, the frequency of which depends on the prevalence of the infection in the community [8]. PZQ is the drug of choice for the treatment of all forms of schistosomiasis due to its high efficacy and excellent safety profile [10]

Objectives

Methods

Findings

Conclusion