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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 : April 8, 2019
Sponsor:
Collaborators:
Swiss Tropical & Public Health Institute
Centre Suisse de Recherches Scientifiques (CSRS)
Information provided by (Responsible Party):
Meta Roestenberg, Leiden University Medical Center

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.


Condition or disease Intervention/treatment Phase
Schistosomiasis Drug: 4x Praziquantel Drug: 1x Praziquantel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : January 14, 2019
Actual Study Completion Date : January 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Drug: 1x Praziquantel
One praziquantel treatment (40 mg/kg) at baseline
Other Name: Biltricide

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.
Drug: 4x Praziquantel
Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.
Other Name: Biltricide




Primary Outcome Measures :
  1. Cure rate [ Time Frame: 8 weeks ]
    The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868385


Locations
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Côte D'Ivoire
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire
Abidjan, Côte D'Ivoire
Sponsors and Collaborators
Leiden University Medical Center
Swiss Tropical & Public Health Institute
Centre Suisse de Recherches Scientifiques (CSRS)
Investigators
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Principal Investigator: Jean Coulibaly Centre Suisse de Recherches Scientifiques (CSRS)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meta Roestenberg, MD PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02868385     History of Changes
Other Study ID Numbers: RePST
2016-003017-10 ( EudraCT Number )
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Meta Roestenberg, Leiden University Medical Center:
Schistosomiasis
Schistosoma mansoni
Bilharzia

Additional relevant MeSH terms:
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Schistosomiasis
Trematode Infections
Helminthiasis
Parasitic Diseases
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents