Schistosoma Haematobium
Conditions
Keywords
Schistosoma haematobium, Praziquantel, Artesunate + Sulfamethoxypyrazine/pyrimethamine, Randomized double blind placebo controlled clinical trial
Brief summary
The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian children. The nul-hypothesis in this study is that the combination of As+SMP is more effective than praziquantel in the treatment of S. haematobium infected children.
Interventions
DRUGArtesunate+Sulfamethoxypyrazine/pyrimethamin
DRUGPraziquantel
Sponsors
Dafra Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 6-15 years * In good health, according to study doctor * Suffering from urinary schistosomiasis, as diagnosed by the presence of S. haematobium eggs in the urine. * Residents of Djalakorodji * Capable of taking oral medication * Written informed consent to participate in the study, obtained from parent or legal guardian.
Exclusion criteria
* Weighing more than 50 kg * Being pregnant or lactating at the time of the study * Patient has a severe concomitant disease, as determined by the clinical examination, such as cerebral cysticercosis, HIV,... * Signs of severe malnutrition (children weighing/measuring more than 3 standard deviations or less than 70% of the median standard reference values determined by WHO, or with systemic oedema affecting both feet). * Hypersensitivity to As, SMP or PZQ * Having taken other antimalarial or antischistosomal medication during the study. * Having participated in previous similar studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the parasite load between the two treatment arms | After 28 days |
| Compare the amount of eggs produced between the two treatment arms | After 28 days |
| Compare cure rate between the two treatment arms | After 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate changes in urine appearance before and after treatment | After 28 days |
| Evaluate changes in haematuria frequency before and after treatment | After 28 days |
Countries
Mali
Outcome results
None listed