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

Sissoko MS, Dabo A, Traoré H, Diallo M, Traoré B, Konaté D, Niaré B, Diakité M, Kamaté B, Traoré A, Bathily A, Tapily A, Touré OB, Cauwenbergh S, Jansen HF, Doumbo OK - PLoS ONE (2009)

Bottom Line: All adverse events were categorized as mild.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Odonto-Stomatology, Malaria Research and Training Center, University of Bamako, Bamako, Mali. mssissoko@mrtcbko.org

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.

Show MeSH

Related in: MedlinePlus

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).
© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC2749939&req=5

pone-0006732-g001: 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).

Mentions: Out of a total of 3033 children (age range 6–15 years) screened for infection, 2233 children did not meet our inclusion criteria. A total of 392 children completed the study in the As+SMP treatment arm. Three children were lost to follow-up, in 3 other cases the protocol was violated, and 2 patients chose to withdraw from the study. In the PZQ treatment arm, one patient 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).


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

Sissoko MS, Dabo A, Traoré H, Diallo M, Traoré B, Konaté D, Niaré B, Diakité M, Kamaté B, Traoré A, Bathily A, Tapily A, Touré OB, Cauwenbergh S, Jansen HF, Doumbo OK - PLoS ONE (2009)

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).
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2749939&req=5

pone-0006732-g001: 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).
Mentions: Out of a total of 3033 children (age range 6–15 years) screened for infection, 2233 children did not meet our inclusion criteria. A total of 392 children completed the study in the As+SMP treatment arm. Three children were lost to follow-up, in 3 other cases the protocol was violated, and 2 patients chose to withdraw from the study. In the PZQ treatment arm, one patient 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).

Bottom Line: All adverse events were categorized as mild.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Odonto-Stomatology, Malaria Research and Training Center, University of Bamako, Bamako, Mali. mssissoko@mrtcbko.org

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.

Show MeSH
Related in: MedlinePlus