Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

Sponsor

Dafra Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00510159

Collaborator

(none)

800

Enrollment

Location

Duration (Months)

199.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schistosoma Haematobium	Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin Drug: Praziquantel	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Randomized Double Blind Clinical Trial in Mali, Comparing the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel in the Treatment of S. Haematobium in Children

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Evaluate changes in urine appearance before and after treatment [After 28 days]
Evaluate changes in haematuria frequency before and after treatment [After 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 15 Years

Sexes Eligible for Study:

All

Accepts 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