Clinical trial NCT00510159: Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schistosoma Haematobium
Keywords: Schistosoma haematobium
Praziquantel
Artesunate + Sulfamethoxypyrazine/pyrimethamine
Randomized double blind placebo controlled clinical trial
Lead sponsor: Dafra Pharma
Sponsor class: INDUSTRY
First posted: 2007-08-01
Enrollment: 800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Compare the parasite load between the two treatment arms
timeFrame: After 28 days
measure: Compare the amount of eggs produced between the two treatment arms
timeFrame: After 28 days
measure: Compare cure rate between the two treatment arms
timeFrame: After 28 days
Secondary outcomes:
measure: Evaluate changes in urine appearance before and after treatment
timeFrame: After 28 days
measure: Evaluate changes in haematuria frequency before and after treatment
timeFrame: After 28 days
Other outcomes:
Locations:
city: Djalakorodji
country: Mali
Study officials:
affiliation: University of Bamako, Mali
name: Mahamadou S Sissoko, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sissoko MS, Dabo A, Traore H, Diallo M, Traore B, Konate D, Niare B, Diakite M, Kamate B, Traore A, Bathily A, Tapily A, Toure OB, Cauwenbergh S, Jansen HF, Doumbo OK. Efficacy of artesunate + sulfamethoxypyrazine/pyrimethamine versus praziquantel in the treatment of Schistosoma haematobium in children. PLoS One. 2009 Oct 5;4(10):e6732. doi: 10.1371/journal.pone.0006732.