Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Schistosomiasis

Intervention / Treatment
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* Drug: 4x Praziquantel
* Drug: 1x Praziquantel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group (A)<br>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<br>* One praziquantel treatment (40 mg/kg) at baseline<br>* Other names: Biltricide;|
| Experimental: Intervention group (B)<br>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<br>* Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.<br>* Other names: Biltricide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate | The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction rates | 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. | 8 weeks | 
| Sensitivity and specificity | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schistosomiasis, Schistosoma mansoni, Bilharzia