RBR-86kcy37
Not Yet Recruiting
Phase 3
Evaluation of the efficacy and safety of pediatric praziquantel in children residing in endemic areas of Bahia and Sergipe
Instituto Gonçalo Moniz (IGM) - Fundação Oswaldo Cruz (Fiocruz-BA)0 sitesJune 14, 2024
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Instituto Gonçalo Moniz (IGM) - Fundação Oswaldo Cruz (Fiocruz-BA)
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 4 and 6 years (cohort 1\) and 3 months to 3 years (cohort 2\); presence of at least 1 Schistosoma mansoni egg detected through parasitological methods; minimum body weight of 8 kg for children between 2 and 6 years and 5 kg for children under 2 years
Exclusion Criteria
- •Presence of conditions that contraindicate the use of praziquantel at the discretion of the physician, such as viral or bacterial infections, diarrhea, gastroenteritis, among others; have undergone treatment with praziquantel in the last 6 months; concomitant treatment with other drugs that can affect the metabolism of praziquantel, such as some antiepileptics, glucocorticoids, chloroquine, rifampicin, or cimetidine; participants with hepatosplenic schistosomiasis; participants with body temperature above 37\.5°C
Outcomes
Primary Outcomes
Not specified
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