Open-label, dose-finding, 2-parts, efficacy phase II study with 3 formulations (rac-PZQ commercial oral tablets, new ODTs of rac- and L-PZQ) in S. mansoni infected children aged 2 6 years (Part 1), followed by an assessment of efficacy and safety with the selected formulation and dosage in S. mansoni infected infants aged 3-24 months (Part 2a) and in S. haematobium infected children aged 2-6 years

Merck KGaA0 个研究点目标入组 520 人开始时间: 2016年2月25日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•¿ Written informed consent from the parents/legal representatives prior to any trial related procedure
•¿ Male and female children aged 2 to 6 years (Part 1 and 2b) and 3 to 24 months (Part 2a)
•¿ S. mansoni positive diagnosis in Part 1 and Part 2a, defined as positive egg counts in stool (>1 egg/1 occasion) according to WHO classification: light (1-99 eggs per gram of faeces), moderate (100-399 eggs per gram of faeces) and heavy (¿400 eggs per gram of faeces) infections
•¿ S. haematobium positive diagnosis in Part 2b, defined as positive egg counts in urine (>2 eggs/10 ml urine) according to WHO classification: light (<50 eggs/10¿ml of urine) and heavy (¿50 eggs/10¿ml of urine) 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 guardian¿s 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 h and 8 days after treatment, as well as 14-21 days after treatment
•- To provide finger prick blood samples for PK studies and blood samples for safety assessments.

•¿ Treatment in the 4 weeks prior to study screening with PZQ, other anti-helminthic, anti-malarial 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 IMP
•¿ Previous history of adverse reactions associated with PZQ treatment
•¿ History of acute or severe chronic disease including hepato-splenic schistosomiasis
•¿ Fever defined as temperature above 38.0°C
•¿ Debilitating illnesses such as tuberculosis, malnutrition, etc.
•¿ 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

发起方