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


RESULTS
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
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.


BACKGROUND
ClinicalTrials.gov NCT00510159.
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
Mahamadou S
MS
Sissoko
Abdoulaye
A
Dabo
Hamidou
H
Traoré
Mouctar
M
Diallo
Boubacar
B
Traoré
Drissa
D
Konaté
Boubacar
B
Niaré
Moussa
M
Diakité
Bourama
B
Kamaté
Abdrahamane
A
Traoré
Aboudramane
A
Bathily
Amadou
A
Tapily
Ousmane B
OB
Touré
Sarah
S
Cauwenbergh
Herwig F
HF
Jansen
Ogobara K
OK
Doumbo
D000293:Adolescent; D000818:Animals; D000962:Antimalarials / Q000627:therapeutic use*; D037621:Artemisinins / Q000008:administration & dosage*; D000077332:Artesunate; D002648:Child; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D011223:Praziquantel / Q000008:administration & dosage*; D011739:Pyrimethamine / Q000008:administration & dosage; D012548:Schistosoma haematobium / Q000378:metabolism*; D012553:Schistosomiasis haematobia / Q000188:drug therapy*; D013415:Sulfalene / Q000008:administration & dosage*; D013997:Time Factors
D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D000077332:Artesunate; D011223:Praziquantel; D013415:Sulfalene; D011739:Pyrimethamine