an open label dose finding safety and efficacy in children and infants infected with schistosomiasis (s.mansoni)

Conditions: Schistosomiasis

Summary: the phase ii study consisted of two parts, part 1 is open label, randomized, controlled and exploratory dose finding in children aged between 2 and 6 years infected with s. mansoni. part 2 investigated efficacy and safety with the selected formulation and dosage in s. mansoni infected children aged between 3 months - 2 years.


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

Keywords: praziquantel odt formulation biltricide