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NCT Number: NCT02868385

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

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.

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Key information

Conditions

Schistosomiasis Helminthiasis Infections Parasitic Diseases Trematode Infections Vector Borne Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Suisse de Recherches Scientifiques en Côte d'Ivoire

Abidjan, Côte d’Ivoire

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4x Praziquantel

Drug

Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.

Other names: Biltricide

1x Praziquantel

Drug

One praziquantel treatment (40 mg/kg) at baseline

Other names: Biltricide

Primary outcomes

  1. Cure rate

    Time frame: 8 weeks

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
  • Swiss Tropical & Public Health Institute

Registry information

Official study 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

Acronym: RePST

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2016
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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