Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

Schistosomiasis Clinical Trial

— RePST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868385
• Other study ID #: RePST
• Secondary ID: 2016-003017-10
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: January 14, 2019

Study information

• Verified date: November 2020
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Schistosomiasis

Intervention

Drug:
• 4x Praziquantel
Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.
• 1x Praziquantel
One praziquantel treatment (40 mg/kg) at baseline

Locations

Country	Name	City	State
Côte D'Ivoire	Centre Suisse de Recherches Scientifiques en Côte d'Ivoire	Abidjan

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Swiss Tropical & Public Health Institute

Country where clinical trial is conducted

Côte D'Ivoire, 

References & Publications (2)

Hoekstra PT, Casacuberta Partal M, Amoah AS, van Lieshout L, Corstjens PLAM, Tsonaka S, Assaré RK, Silué KD, Meité A, N'Goran EK, N'Gbesso YK, Roestenberg M, Knopp S, Utzinger J, Coulibaly JT, van Dam GJ. Repeated doses of Praziquantel in Schistosomiasis Treatment (RePST) - single versus multiple praziquantel treatments in school-aged children in Côte d'Ivoire: a study protocol for an open-label, randomised controlled trial. BMC Infect Dis. 2018 Dec 14;18(1):662. doi: 10.1186/s12879-018-3554-2. — View Citation

Hoekstra PT, Casacuberta-Partal M, van Lieshout L, Corstjens PLAM, Tsonaka R, Assaré RK, Silué KD, Meité A, N'Goran EK, N'Gbesso YK, Amoah AS, Roestenberg M, Knopp S, Utzinger J, Coulibaly JT, van Dam GJ. Efficacy of single versus four repeated doses of p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate	The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique	8 weeks
Secondary	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
Secondary	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