Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)
- Registration Number
- NCT02868385
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- 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
- Known allergy to study medication (i.e. praziquantel and albendazole)
- Pregnancy
- Lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group (A) 1x Praziquantel 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 group (B) 4x Praziquantel 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.
- Primary Outcome Measures
Name Time Method Cure rate 8 weeks The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique
- Secondary Outcome Measures
Name Time Method Reduction rates 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 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.
Trial Locations
- Locations (1)
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire
🇨🇮Abidjan, Côte D'Ivoire