Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

NCT ID: NCT02868385

Last Updated: 2020-11-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-01-14

Brief Summary

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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.

Detailed Description

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Conditions

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Schistosomiasis

Keywords

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Schistosomiasis Schistosoma mansoni Bilharzia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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).

Group Type ACTIVE_COMPARATOR

1x Praziquantel

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

4x Praziquantel

Intervention Type DRUG

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.

Intervention Type DRUG

1x Praziquantel

One praziquantel treatment (40 mg/kg) at baseline

Intervention Type DRUG

Other Intervention Names

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Biltricide Biltricide

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Tropical & Public Health Institute

OTHER

Sponsor Role collaborator

Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Meta Roestenberg

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Côte d’Ivoire

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.

Reference Type BACKGROUND
PMID: 30547750 (View on PubMed)

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.

Reference Type RESULT
PMID: 32196506 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36548444 (View on PubMed)

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