Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)

Conditions

Schistosomiasis

Keywords

Schistosomiasis, Schistosoma mansoni, Bilharzia

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.

Pytsje T. Hoekstra, Miriam Casacuberta-Partal, Lisette van Lieshout, Paul L. A. M. Corstjens, Roula Tsonaka et al. (15 authors)

PLoS neglected tropical diseases2022-12-2219 citations

10.1371/journal.pntd.0011008

Efficacy of single versus four repeated doses of praziquantel against Schistosoma mansoni infection in school-aged children from Côte d'Ivoire based on Kato-Katz and POC-CCA: An open-label, randomised controlled trial (RePST)

Pytsje T. Hoekstra, Miriam Casacuberta-Partal, Lisette van Lieshout, Paul L. A. M. Corstjens, Roula Tsonaka et al. (16 authors)

PLoS neglected tropical diseases2020-03-2041 citations

10.1371/journal.pntd.0008189

Repeated doses of Praziquantel in Schistosomiasis Treatment (RePST) - single versus multiple praziquantel treatments in school-aged children in Côte d'Ivoire: a study protocol for an open-label, randomised controlled trial.

Hoekstra PT, Casacuberta Partal M, Amoah AS, van Lieshout L, Corstjens PLAM, Tsonaka S, Assaré RK, Silué KD, Meité A, N'Goran EK, N'Gbesso YK, Roestenberg M, Knopp S, Utzinger J, Coulibaly JT, van Dam GJ.

2018-12-146 citations

10.1186/s12879-018-3554-2

Interventions

DRUG4x Praziquantel

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

DRUG1x Praziquantel

One praziquantel treatment (40 mg/kg) at baseline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Cure rate	8 weeks	The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique

Secondary

Measure	Time frame	Description
Reduction rates	8 weeks	The difference in egg reduction rate (by Kato-Katz), cure rate and circulating anodic and cathodic antigen and DNA reduction rate after multiple doses of praziquantel (40 mg/kg) by Kato Katz (KK), point-of-care circulating cathodic antigen assay (POC-CCA), up-converting phosphor lateral flow circulating anodic antigen assay (UCP-LF-CAA) and polymerase chain reaction (PCR), respectively.
Sensitivity and specificity	8 weeks	Sensitivity and specificity of Kato Katz (KK), point-of-care circulating cathodic antigen assay (POC-CCA), up-converting phosphor lateral flow circulating anodic antigen assay (UCP-LF-CAA) and polymerase chain reaction (PCR) at different time points.

Countries

Côte d’Ivoire

Outcome results

None listed