Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT02806232
Eligibility Criteria:
Inclusion Criteria:
* Male and female children aged 2 to 6 years (Part 1) and 3 to 24 months (Part 2)
* S. mansoni positive diagnosis defined as positive egg counts in stool (greater than \[\>\]1 egg/1 occasion) according to World Health Organization (WHO) classification : light (1-99 eggs per gram of faeces), moderate (100-399 eggs per gram of faeces) and heavy (greater than or equal to \[\>=\]400 eggs per gram of faeces) infections
* Minimum weight of 8.0 kg in 2- to 6-year-old children and of 4.0 kg in 3- to 24-month infants
• Parents/legal representative ability to communicate well with the Investigator, to understand the protocol requirements and restrictions, and willing their children to comply with the requirements of the entire trial, i.e.
* To be examined by a study physician at screening and 14-21 days after treatment
* To provide stool and urine samples at screening, 24 hours and 8 days after treatment, as well as 14-21 days after treatment
* To provide finger prick blood samples for Pharmacokinetics (PK) studies and blood samples for safety assessments
Exclusion Criteria:
* Treatment in the 4 weeks prior to study screening with Praziquantel (PZQ) , other anti-helminthic, antimalarial or anti-retroviral compounds or any other medication that might affect the PK of PZQ such as certain antiepileptics (e.g., carbamazepine or phenytoin), glucocorticosteroids (e.g., dexamethasone), chloroquine, rifampicin or cimetidine
* For children being breast fed, treatment of the mothers/wet nurses with PZQ in the 3 days prior to administration of Investigational medicinal product
* Previous history of adverse reactions associated with PZQ treatment
* Marked increases of the liver transaminases (alanine aminotransferase and/or aspartate aminotransferase) above 3x Upper Limit of Normal (ULN)
* History of acute or severe chronic disease including hepato-splenic schistosomiasis
* Fever defined as temperature above 38.0 degree centigrade
* Debilitating illnesses such as tuberculosis, malnutrition, etc. as well as a medical history of seizures
* Mixed S. haematobium and S. mansoni infections
* Findings in the clinical examination of schistosome-infected children participating in the study as performed by the study clinician on the treatment day, that in the opinion of the Investigator constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct or evaluation
* Unlikelihood to comply with the protocol requirements, instructions and trial-related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
6 Years
Study:
NCT02806232
Study Brief:
Protocol Section:
NCT02806232