A Phase 3 interventional study of 4x Praziquantel and 1x Praziquantel in Schistosomiasis, sponsored by Leiden University Medical Center. Completed at 1 site in Côte D'Ivoire. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-11-18.
Sponsored by Leiden University Medical Center · Phase 3, Interventional, and Treatment
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.
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's enrollment of 167 is below the median of 289 across 52 interventional studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.
Also known as: Biltricide
One praziquantel treatment (40 mg/kg) at baseline
Also known as: Biltricide
Cure rate
The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 8 weeks
Plan to share: Undecided
Ran from Oct 2018 to primary completion in Jan 2019, 3 months.
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Praziquantel
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