Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)
NCT ID: NCT02868385
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
167 participants
INTERVENTIONAL
2018-10-01
2019-01-14
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
1x Praziquantel
One praziquantel treatment (40 mg/kg) at baseline
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.
4x Praziquantel
Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
* Lactating
5 Years
18 Years
ALL
No
Sponsors
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Swiss Tropical & Public Health Institute
OTHER
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Meta Roestenberg
MD PhD
Principal Investigators
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Jean Coulibaly
Role: PRINCIPAL_INVESTIGATOR
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Locations
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Centre Suisse de Recherches Scientifiques en Côte d'Ivoire
Abidjan, , Côte d’Ivoire
Countries
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References
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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.
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.
Hoekstra PT, Casacuberta-Partal M, van Lieshout L, Corstjens PLAM, Tsonaka R, Assare RK, Silue KD, N'Goran EK, N'Gbesso YK, Brienen EAT, Roestenberg M, Knopp S, Utzinger J, Coulibaly JT, van Dam GJ. Limited efficacy of repeated praziquantel treatment in Schistosoma mansoni infections as revealed by highly accurate diagnostics, PCR and UCP-LF CAA (RePST trial). PLoS Negl Trop Dis. 2022 Dec 22;16(12):e0011008. doi: 10.1371/journal.pntd.0011008. eCollection 2022 Dec.
Other Identifiers
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2016-003017-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RePST
Identifier Type: -
Identifier Source: org_study_id