Therapeutics
Conditions
Interventions
This is a Phase III clinical trial composed of two complementary studies conducted in rural communities in the states of Bahia and Sergipe, Brazil, designed to evaluate the efficacy and safety of pedi
all children will receive PZQ-PED at a single oral dose of 50 mg/kg after feeding, according to the protocol previously tested by the Pediatric Praziquantel Consortium. In both studies, treatment will
Sponsors
Centro de Pesquisas Gonçalo Moniz - Fundação Oswaldo Cruz - BA
Instituto Gonçalo Moniz (IGM) - Fundação Oswaldo Cruz (Fiocruz-BA)
Eligibility
Age
3 Months to 6 Years
Inclusion criteria
Inclusion criteria: Age between 3 months and 6 years; both sexes; presence of at least one *Schistosoma mansoni* egg detected by the parasitological methods used; minimum body weight of 8 kg for children aged 2 to 6 years and 5 kg for children under 2 years of age
Exclusion criteria
Exclusion criteria: Presence of conditions that contraindicate the use of praziquantel at the physician’s discretion, such as viral or bacterial infections, diarrhea, gastroenteritis, among others; prior treatment with praziquantel within the past 6 months; concomitant treatment with other drugs that may affect praziquantel metabolism, such as certain antiepileptics, glucocorticoids, chloroquine, rifampicin, or cimetidine; participants with hepatosplenic schistosomiasis; participants with body temperature above 37.5 °C; for infants and breastfeeding children, maternal treatment with praziquantel within the 3 days preceding the administration of pediatric praziquantel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find, through the Kato-Katz method, absence of Schistosoma mansoni eggs, 17 to 21 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to identify, using the Kato-Katz method with one stool sample and three slides, a reduction in Schistosoma mansoni egg counts between 17 and 21 days after treatment; the occurrence and severity of adverse events related to the study drug, from administration through day 21, using the adverse event reporting form; and the number of participants presenting alterations in renal, hepatic, and cardiac functions between 17 and 21 days post-treatment, based on biochemical marker assessment. In addition, the operational feasibility of the study protocol will be evaluated, considering aspects such as completeness of study documentation, compliance with safety and monitoring procedures, traceability of the investigational product, and participant adherence to the study protocol, including attendance at scheduled visits and adherence to the defined timelines. | — |
Countries
Brazil
Contacts
Public ContactRicardo Oliveira
Instituto Gonçalo Moniz (IGM) - Fundação Oswaldo Cruz (Fiocruz-BA)
Outcome results
None listed