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Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST) (RePST)

Primary Purpose

Schistosomiasis

Status
Completed
Phase
Phase 3
Locations
Côte D'Ivoire
Study Type
Interventional
Intervention
4x Praziquantel
1x Praziquantel
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schistosomiasis focused on measuring Schistosomiasis, Schistosoma mansoni, Bilharzia

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Suisse de Recherches Scientifiques en Côte d'Ivoire

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group (A)

Intervention group (B)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Cure rate
The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique

Secondary Outcome Measures

Reduction rates
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
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.

Full Information

First Posted
August 9, 2016
Last Updated
November 16, 2020
Sponsor
Leiden University Medical Center
Collaborators
Swiss Tropical & Public Health Institute, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
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1. Study Identification

Unique Protocol Identification Number
NCT02868385
Brief Title
Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)
Acronym
RePST
Official Title
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
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Swiss Tropical & Public Health Institute, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis
Keywords
Schistosomiasis, Schistosoma mansoni, Bilharzia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group (A)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Intervention group (B)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
4x Praziquantel
Other Intervention Name(s)
Biltricide
Intervention Description
Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.
Intervention Type
Drug
Intervention Name(s)
1x Praziquantel
Other Intervention Name(s)
Biltricide
Intervention Description
One praziquantel treatment (40 mg/kg) at baseline
Primary Outcome Measure Information:
Title
Cure rate
Description
The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Reduction rates
Description
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.
Time Frame
8 weeks
Title
Sensitivity and specificity
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Coulibaly
Organizational Affiliation
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire
City
Abidjan
Country
Côte D'Ivoire

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30547750
Citation
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.
Results Reference
background
PubMed Identifier
32196506
Citation
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.
Results Reference
result

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Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

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