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

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

Abstract

Background: Large 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.

Methods: An 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.

Discussion: This 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 registration: The study is registered at EudraCT (2016-003017-10, date of registration: 22 July 2016) and ( NCT02868385 , date of registration: 16 August 2016).

Keywords: CAA; CCA; Diagnostic test; Kato-Katz; PCR; Praziquantel; Schistosoma mansoni; Schistosomiasis; Treatment efficacy.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for this study has been obtained from the National Ethics Committee of the Ministry of Health in Côte d’Ivoire (CNESVS, registration number 091–18/MSHP/CNESVS-km, 27 June 2018) as well as from the Direction de la Pharmacie, du Médicament et des Laboratoires de Côte d’Ivoire (DPML, registration number 99433-/MSHP/DGS/DPML/DAR and clinical trial number ECCI00618, 22 October 2018).

Oral and signed assent and signed informed consent will be obtained from their legally appointed representative, usually a parent or guardian, responsible for making decisions on their behalf, prior to study enrolment.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow-diagram
Fig. 2
Fig. 2
Schematic representation of follow-up, treatment and sampling procedures in the standard and intense treatment group.

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