Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST) (RePST)
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|ClinicalTrials.gov Identifier: NCT02868385|
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : November 18, 2020
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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.
|Condition or disease||Intervention/treatment||Phase|
|Schistosomiasis||Drug: 4x Praziquantel Drug: 1x Praziquantel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||167 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|
|Actual Study Start Date :||October 1, 2018|
|Actual Primary Completion Date :||January 14, 2019|
|Actual Study Completion Date :||January 14, 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
Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.
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.
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|Ages Eligible for Study:||5 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868385
|Centre Suisse de Recherches Scientifiques en Côte d'Ivoire|
|Abidjan, Côte D'Ivoire|
|Principal Investigator:||Jean Coulibaly||Centre Suisse de Recherches Scientifiques en Cote d'Ivoire|
|Responsible Party:||Meta Roestenberg, MD PhD, Leiden University Medical Center|
|Other Study ID Numbers:||
2016-003017-10 ( EudraCT Number )
|First Posted:||August 16, 2016 Key Record Dates|
|Last Update Posted:||November 18, 2020|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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