Urogenital schistosomiasis
Conditions
Interventions
STUDY ARM PAIR I
STUDY ARM PAIR II
Sponsors
Bernhard Nocht Institute for Tropical Medicine BNITM
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of pyronaridine/artesunate and pyronaridine/artesunate/praziquantel in participants with uncomplicated Schistosoma haematobium parasites;To assess the time to re-infection with Schistosoma haematobium after treatment with PYR/ART/PZQ compared with PZQ standard treatment assessed by light microscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the safety and tolerability of study regimens in each study arm during the observation period - To assess the proportion of participants with haematuria in each study arm at D42 after administration of study drugs - To assess the proportion of participants with an incidental Plasmodium parasitaemia during the observation period | — |
Countries
Gabon
Contacts
Public ContactLidwine Badjina
BNITM
Outcome results
None listed