Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

Leiden University Medical Center (LUMC)

Status and phase: Completed; Phase 3

Conditions: Schistosomiasis

Treatments: Drug: 4x Praziquantel; Drug: 1x Praziquantel

Study type: Interventional

Funder types: Other

Identifiers

NCT02868385

RePST

2016-003017-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

167 participants in 2 patient groups

Control group (A)

Active Comparator group

Description:

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).

Treatment:

Drug: 1x Praziquantel

Intervention group (B)

Experimental group

Description:

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.

Treatment:

Drug: 4x Praziquantel