Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

NCT02868385 | Completed Phase 3

• 2 other identifiers: RePST2016-003017-10
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Schistosomiasis

Keywords

Schistosomiasis; Schistosoma mansoni; Bilharzia

Outcome Measures

Primary Outcomes (1)

• Cure rate

  The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique

  8 weeks

Secondary Outcomes (2)

• Reduction rates

  8 weeks

• Sensitivity and specificity

  8 weeks

Study Arms (2)

Control group (A)

ACTIVE COMPARATOR

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

Intervention group (B)

EXPERIMENTAL

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

Interventions

4x Praziquantel DRUG

Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.

Also known as: Biltricide

Intervention group (B)

1x Praziquantel DRUG

One praziquantel treatment (40 mg/kg) at baseline

Also known as: Biltricide

Control group (A)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to study medication (i.e. praziquantel and albendazole)
• Pregnancy
• Lactating

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Swiss Tropical & Public Health Institute: collaborator
• Centre Suisse de Recherches Scientifiques en Cote d'Ivoire: collaborator

Study Sites (1)

Centre Suisse de Recherches Scientifiques en Côte d'Ivoire

Abidjan, Côte d’Ivoire

Location

Related Publications (3)

• 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.

  PMID: 30547750 BACKGROUND

• 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.

  PMID: 32196506 RESULT

• 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.

  PMID: 36548444 DERIVED

MeSH Terms

Conditions

Schistosomiasis

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean Coulibaly

  Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 16, 2016
• Study Start: October 1, 2018
• Primary Completion: January 14, 2019
• Study Completion: January 14, 2019
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

CÔ (1)