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

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ClinicalTrials.gov Identifier: NCT02868385
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : November 18, 2020
Sponsor:
Collaborators:
Swiss Tropical & Public Health Institute
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Information provided by (Responsible Party):
Meta Roestenberg, Leiden University Medical Center

Tracking Information
First Submitted Date  ICMJE August 9, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date November 18, 2020
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
Cure rate [ Time Frame: 8 weeks ]
The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schistosomiasis
Intervention  ICMJE
  • Drug: 4x Praziquantel
    Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.
    Other Name: Biltricide
  • Drug: 1x Praziquantel
    One praziquantel treatment (40 mg/kg) at baseline
    Other Name: Biltricide
Study Arms  ICMJE
  • 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).
    Intervention: Drug: 1x Praziquantel
  • 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.
    Intervention: Drug: 4x Praziquantel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2019)
167
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2016)
1000
Actual Study Completion Date  ICMJE January 14, 2019
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Côte D'Ivoire
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02868385
Other Study ID Numbers  ICMJE RePST
2016-003017-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Meta Roestenberg, Leiden University Medical Center
Study Sponsor  ICMJE Leiden University Medical Center
Collaborators  ICMJE
  • Swiss Tropical & Public Health Institute
  • Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Investigators  ICMJE
Principal Investigator: Jean Coulibaly Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
PRS Account Leiden University Medical Center
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP