Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

Schistosoma Haematobium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510159
• Other study ID #: 2007/S4
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 31, 2007
• Last updated: January 17, 2008
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: July 2007
• Source: Dafra Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schistosoma Haematobium

Intervention

Drug:
• Artesunate+Sulfamethoxypyrazine/pyrimethamin

• Praziquantel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dafra Pharma

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the parasite load between the two treatment arms		After 28 days
Primary	Compare the amount of eggs produced between the two treatment arms		After 28 days
Primary	Compare cure rate between the two treatment arms		After 28 days
Secondary	Evaluate changes in urine appearance before and after treatment		After 28 days
Secondary	Evaluate changes in haematuria frequency before and after treatment		After 28 days