Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST) (RePST)
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|ClinicalTrials.gov Identifier: NCT02868385|
Recruitment Status : Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : September 26, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||October 2019|
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
Five consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, 6, and 8.
Other Name: Biltricide
- Cure rate [ Time Frame: 8 weeks ]The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868385
|Contact: Govert van Dam||+31 71 526 44 firstname.lastname@example.org|
|Centre Suisse de Recherches Scientifiques en Côte d'Ivoire||Not yet recruiting|
|Abidjan, Côte D'Ivoire|
|Contact: Jean Coulibaly email@example.com|
|Contact: Rufin Assaré firstname.lastname@example.org|
|Principal Investigator: Jean Coulibaly|
|Sub-Investigator: Rufin Assaré|
|Principal Investigator:||Jean Coulibaly||Centre Suisse de Recherches Scientifiques (CSRS)|