Clinical trial NCT02868385: Repeated Doses of Praziquantel in Schistosomiasis Treatment (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schistosomiasis
Keywords: Schistosomiasis
Schistosoma mansoni
Bilharzia
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Swiss Tropical & Public Health Institute
name: Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
First posted: 2016-08-16
Enrollment: 167
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cure rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Reduction rates
timeFrame: 8 weeks
measure: Sensitivity and specificity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: Centre Suisse de Recherches Scientifiques en Côte d'Ivoire
Study officials:
affiliation: Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
name: Jean Coulibaly
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoekstra PT, Casacuberta Partal M, Amoah AS, van Lieshout L, Corstjens PLAM, Tsonaka S, Assare RK, Silue KD, Meite 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 Cote 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.
citation: Hoekstra PT, Casacuberta-Partal M, van Lieshout L, Corstjens PLAM, Tsonaka R, Assare RK, Silue KD, Meite 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 praziquantel against Schistosoma mansoni infection in school-aged children from Cote d'Ivoire based on Kato-Katz and POC-CCA: An open-label, randomised controlled trial (RePST). PLoS Negl Trop Dis. 2020 Mar 20;14(3):e0008189. doi: 10.1371/journal.pntd.0008189. eCollection 2020 Mar.