PACTR202402599048090RecruitingPhase 2
Efficacy and safety of pyronaridine/artesunate and pyronaridine/artesunate/praziquantel for treatment of uncomplicated Schistosoma haematobium infection in Gabonese adolescents and children
Bernhard Nocht Institute for Tropical Medicine BNITM0 sites108 target enrollmentStarted: November 13, 2023Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 108
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 Year(s) to 5 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Participants aged between 5 years and below 18 years
- •Microscopically-determined Schistosoma haematobium infection
- •Uncomplicated Schistosoma haematobium infection defined by: presence of microscopically-determined Schistosoma haematobium eggs in urine with absence of Katayama fever and absence of clinically significant urinary tract pathology (see exclusion criteria).
- •Written informed consent must be obtained before any study assessment is performed.
- •Willingness not to take drugs or substances which could have an impact on study drug blood levels (see inclusion/exclusion criteria in study protocol).
- •Women only of reproductive age: Must agree to practice continuous contraception for the duration of the study.
Exclusion Criteria
- •Presence of Katayama fever
- •Presence of axillary temperature of >37.5°C
- •Presence of clinically significant urinary tract pathology. The diagnoses of clinically significant urinary tract pathologies are made by the clinical investigator
- •Pregnancy or breast-feeding
- •Use of drugs with known antischistosomal activity within 2 months of enrolment into study (including praziquantel and antimalarial treatment with artemisinin-combination therapies)
- •Contraindications or known allergy to pyronaridine/artesunate or praziquantel
- •Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the participant because of participation in the study (e.g. renal transplantation etc.), affect the ability of the participant to participate in the study or impair interpretation of the study data
- •Participants unable to be closely followed for social, geographic or psychological reasons
- •Haemoglobin level below 8 g/dL
- •Previous participation in the CORMA-BIL study (multiple participation not possible)
Investigators
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