Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

Dafra Pharma

Status and phase

Completed

Phase 3

Phase 2

Conditions

Schistosoma Haematobium

Treatments

Drug: Praziquantel

Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00510159

2007/S4

Details and patient eligibility

About

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.

Enrollment

800 patients

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

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