Clinical Trial: Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST): An Open Label, Randomized Controlled Trial of Single vs. Multiple Treatments of Praziquantel in Intest

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 Summary:
Sponsor: Leiden University Medical Center

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Leiden University Medical Center

Dates:
Date Received: August 9, 2016
Date Started: January 2017
Date Completion: December 2017
Last Updated: August 11, 2016
Last Verified: August 2016