Efficacy of artesunate + sulfamethoxypyrazine/pyrimethamine versus praziquantel in the treatment of Schistosoma haematobium in children

Mahamadou S Sissoko, Abdoulaye Dabo, Hamidou Traoré, Mouctar Diallo, Boubacar Traoré, Drissa Konaté, Boubacar Niaré, Moussa Diakité, Bourama Kamaté, Abdrahamane Traoré, Aboudramane Bathily, Amadou Tapily, Ousmane B Touré, Sarah Cauwenbergh, Herwig F Jansen, Ogobara K Doumbo, Mahamadou S Sissoko, Abdoulaye Dabo, Hamidou Traoré, Mouctar Diallo, Boubacar Traoré, Drissa Konaté, Boubacar Niaré, Moussa Diakité, Bourama Kamaté, Abdrahamane Traoré, Aboudramane Bathily, Amadou Tapily, Ousmane B Touré, Sarah Cauwenbergh, Herwig F Jansen, Ogobara K Doumbo

Abstract

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.

Conflict of interest statement

Competing Interests: SC and JFH declare that they are employed by Dafra Pharma, the organisation sponsoring this study and manufacturing the trial interventions. JFH is a member of the Board of Directors of Dafra Pharma.

Figures

Figure 1. Trial profile.
Figure 1. Trial profile.
Out of a total of 3033 children (age range 6–15 years) screened for infection, 2233 children did not meet inclusion. A total of 392 children completed the study in the As/SMP treatment arm. Three children were lost to follow-up, in 3 cases the protocol was violated, and 2 patients chose to withdraw from the study. One patient assigned to the PZQ treatment arm received both medications and was withdrawn from analysis. Six children were lost to follow-up, 1 patient voluntarily withdrew from the study, and the protocol was violated in 4 children. A total of 389 children completed the study in the PZQ treatment arm (Figure 1).

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Source: PubMed

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