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.


Background: This study was conducted to determine the efficacy of the antimalarial artemisinin-based combination therapy (ACT) artesunate +sulfamethoxypyrazine/pyrimethamine (As+SMP), administered in doses used for malaria, to treat Schistosoma haematobium in school aged children.

Methodology/principal findings: The study was conducted in Djalakorodji, a peri-urban area of Bamako, Mali, using a double blind setup in which As+SMP was compared with praziquantel (PZQ). Urine samples were examined for Schistosoma haematobium on days -1, 0, 28 and 29. Detection of haematuria, and haematological and biochemical exams were conducted on day 0 and day 28. Clinical exams were performed on days 0, 1, 2, and 28. A total of 800 children were included in the trial. The cure rate obtained without viability testing was 43.9% in the As+SMP group versus 53% in the PZQ group (Chi(2) = 6.44, p = 0.011). Egg reduction rates were 95.6% with PZQ in comparison with 92.8% with As+SMP, p = 0.096. The proportion of participants who experienced adverse events related to the medication was 0.5% (2/400) in As+SMP treated children compared to 2.3% (9/399) in the PZQ group (p = 0.033). Abdominal pain and vomiting were the most frequent adverse events in both treatment arms. All adverse events were categorized as mild.

Conclusions/significance: The study demonstrates that PZQ was more effective than As+SMP for treating Schistosoma haematobium. However, the safety and tolerability profile of As+SMP was similar to that seen with PZQ. Our findings suggest that further investigations seem justifiable to determine the dose/efficacy/safety pattern of As+SMP in the treatment of Schistosoma infections.

Trial registration: ClinicalTrials.gov NCT00510159.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Animals
  • Antimalarials / therapeutic use*
  • Artemisinins / administration & dosage*
  • Artesunate
  • Child
  • Double-Blind Method
  • Drug Combinations*
  • Female
  • Humans
  • Male
  • Praziquantel / administration & dosage*
  • Pyrimethamine / administration & dosage
  • Schistosoma haematobium / metabolism*
  • Schistosomiasis haematobia / drug therapy*
  • Sulfalene / administration & dosage*
  • Time Factors


  • Antimalarials
  • Artemisinins
  • Drug Combinations
  • Artesunate
  • Praziquantel
  • Sulfalene
  • Pyrimethamine

Associated data

  • ClinicalTrials.gov/NCT00510159