Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

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Brief Title

Repeated Doses of Praziquantel in Schistosomiasis Treatment (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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Cure rate

Secondary Outcome

 Reduction rates

Condition

Schistosomiasis

Intervention

4x Praziquantel

Study Arms / Comparison Groups

 Control group (A)
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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

167

Start Date

October 1, 2018

Completion Date

January 14, 2019

Primary Completion Date

January 14, 2019

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
      

Gender

All

Ages

5 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Jean Coulibaly, , 

Location Countries

Côte D'Ivoire

Location Countries

Côte D'Ivoire

Administrative Informations


NCT ID

NCT02868385

Organization ID

RePST

Secondary IDs

2016-003017-10

Responsible Party

Principal Investigator

Study Sponsor

Leiden University Medical Center

Collaborators

 Swiss Tropical & Public Health Institute

Study Sponsor

Jean Coulibaly, Principal Investigator, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire


Verification Date

April 2019