Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

Overview

An open label, randomized controlled trial of single vs. multiple treatments of praziquantel in intestinal African schistosomiasis in Côte d'Ivoire This study aims to determine the efficacy of repeated (up to four times) praziquantel treatment against S. mansoni infection in school-age children from Côte d'Ivoire using the traditional Kato-Katz thick smear technique, but also with more accurate and non-invasive antigen- and DNA-detection methods.

Full Title of Study: “Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST): An Open Label, Randomized Controlled Trial of Single vs. Multiple Treatments of Praziquantel in Intestinal African Schistosomiasis in Côte d’Ivoire”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 14, 2019

Interventions

  • Drug: 4x Praziquantel
    • Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.
  • Drug: 1x Praziquantel
    • One praziquantel treatment (40 mg/kg) at baseline

Arms, Groups and Cohorts

  • Active Comparator: Control group (A)
    • 1x praziquantel: Children assigned to group A receive a standard single oral dose of praziquantel (40 mg/kg) at baseline (week 0) and will receive no further treatment until the final visit (week 8).
  • Experimental: Intervention group (B)
    • 4x praziquantel: Children assigned to group B receive a standard single oral dose of praziquantel (40 mg/kg) at baseline (week 0) and will receive three consecutive praziquantel treatments (40 mg/kg) in the following six weeks with 2 weeks intervals.

Clinical Trial Outcome Measures

Primary Measures

  • Cure rate
    • Time Frame: 8 weeks
    • The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique

Secondary Measures

  • Reduction rates
    • Time Frame: 8 weeks
    • The difference in egg reduction rate (by Kato-Katz), cure rate and circulating anodic and cathodic antigen and DNA reduction rate after multiple doses of praziquantel (40 mg/kg) by Kato Katz (KK), point-of-care circulating cathodic antigen assay (POC-CCA), up-converting phosphor lateral flow circulating anodic antigen assay (UCP-LF-CAA) and polymerase chain reaction (PCR), respectively.
  • Sensitivity and specificity
    • Time Frame: 8 weeks
    • Sensitivity and specificity of Kato Katz (KK), point-of-care circulating cathodic antigen assay (POC-CCA), up-converting phosphor lateral flow circulating anodic antigen assay (UCP-LF-CAA) and polymerase chain reaction (PCR) at different time points.

Participating in This Clinical Trial

Inclusion Criteria

  • Subject has a confirmed S. mansoni infection (positive POC-CCA test result and at least one positive out of triplicate Kato-Katz thick smears) – Subject is aged between 5 and 18 years and otherwise in good health – Subject has received no recent praziquantel treatment in the past month – Subject has provided oral assent and provided written informed consent signed by parents/legal guardian – Subject is able and willing to provide multiple stool and urine samples during study Exclusion Criteria:

  • Known allergy to study medication (i.e. praziquantel and albendazole) – Pregnancy – Lactating

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Leiden University Medical Center
  • Collaborator
    • Swiss Tropical & Public Health Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Meta Roestenberg, MD PhD – Leiden University Medical Center
  • Overall Official(s)
    • Jean Coulibaly, Principal Investigator, Centre Suisse de Recherches Scientifiques en Cote d’Ivoire

References

Hoekstra PT, Casacuberta Partal M, Amoah AS, van Lieshout L, Corstjens PLAM, Tsonaka S, Assare RK, Silue KD, Meite A, N'Goran EK, N'Gbesso YK, Roestenberg M, Knopp S, Utzinger J, Coulibaly JT, van Dam GJ. Repeated doses of Praziquantel in Schistosomiasis Treatment (RePST) – single versus multiple praziquantel treatments in school-aged children in Cote d'Ivoire: a study protocol for an open-label, randomised controlled trial. BMC Infect Dis. 2018 Dec 14;18(1):662. doi: 10.1186/s12879-018-3554-2.

Citations Reporting on Results

Hoekstra PT, Casacuberta-Partal M, van Lieshout L, Corstjens PLAM, Tsonaka R, Assare RK, Silue KD, Meite A, N'Goran EK, N'Gbesso YK, Amoah AS, Roestenberg M, Knopp S, Utzinger J, Coulibaly JT, van Dam GJ. Efficacy of single versus four repeated doses of praziquantel against Schistosoma mansoni infection in school-aged children from Cote d'Ivoire based on Kato-Katz and POC-CCA: An open-label, randomised controlled trial (RePST). PLoS Negl Trop Dis. 2020 Mar 20;14(3):e0008189. doi: 10.1371/journal.pntd.0008189. eCollection 2020 Mar.

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