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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003017-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Swiss Tropical & Public Health Institute | OTHER |
| Centre Suisse de Recherches Scientifiques en Cote d'Ivoire | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4x Praziquantel | Drug | Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cure rate | The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction rates | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Coulibaly | Centre Suisse de Recherches Scientifiques en Cote d'Ivoire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Suisse de Recherches Scientifiques en Côte d'Ivoire | Abidjan | Côte d’Ivoire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30547750 | Background | 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. | |
| 32196506 |
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| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011223 | Praziquantel |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 1x Praziquantel | Drug | One praziquantel treatment (40 mg/kg) at baseline |
|
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| 8 weeks |
| Sensitivity and specificity | 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. | 8 weeks |
| Result |
| 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. |
| 36548444 | Derived | 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. |
| D000079426 |
| Vector Borne Diseases |