Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dafra Pharma
• Treatments: Artemisinins; Artesunate; Praziquantel; Pyrimethamine; Sulfalene

Criteria

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