Paediatrics
Conditions
Interventions
commercial rac-PZQ tablets (Biltricide®)
Rac-PZQ ODTs
L-PZQ ODTs
Rac- or L-PZQ ODTs
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¿ 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.
Exclusion criteria
Exclusion criteria: ¿ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure defined as no parasite eggs in the stools (S. mansoni infections) or urine (S. haematobium infections) 14-21 days after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Egg Reduction Rate (ERR, %) calculated based on the arithmetic (and geometric) mean egg count per gram of stool (epg) before and 14-21 days after treatment (as determined by Kato-Katz method).;¿ Cure defined as no parasite eggs in the stools as assessed by the commercially available POC-CCA test for S. mansoni;Changes in laboratory safety parameters and vital signs (body temperature, blood pressure and pulse rate);¿ Occurrence, nature, severity and outcome of adverse events;Occurrence of Adverse Drug Reactions per treatment group | — |
Countries
Cote Divoire
Contacts
Public ContactEric Huber
Swiss TPH Project Leader
Outcome results
None listed