Efficacy and safety of mefloquine, artesunate, mefloquine-artesunate, and praziquantel against Schistosoma haematobium: randomized, exploratory open-label trial

Clin Infect Dis. 2010 May 1;50(9):1205-13. doi: 10.1086/651682.

Abstract

Background: Morbidity control of schistosomiasis relies on a single drug, praziquantel. The antimalarial drug mefloquine possesses interesting antischistosomal properties, yet no clinical studies have been performed.

Methods: We conducted a randomized, exploratory open-label trial to assess the efficacy and safety of mefloquine (25 mg/kg), artesunate (3 doses of 4 mg/kg), mefloquine-artesunate (3 doses of 100 mg artesunate plus 250 mg mefloquine), and praziquantel (40 mg/kg) against Schistosoma haematobium. The effects on Schistosoma mansoni, malaria parasitemia, soil-transmitted helminths, and intestinal protozoa were also determined.

Results: A total of 83 S. haematobium-infected schoolchildren were included in the study. Cure rates of mefloquine, artesunate, mefloquine-artesunate, and praziquantel against S. haematobium at day 26 after treatment were 21%, 25%, 61%, and 88%, respectively. Both mefloquine-artesunate and praziquantel resulted in egg reduction rates >95%. Significantly lower egg reduction rates were seen in the artesunate (85%) and mefloquine groups (74%). In children coinfected with S. mansoni, praziquantel and mefloquine-artesunate, but not mefloquine and artesunate alone, resulted in high cure rates and egg reduction rates. Mefloquine, artesunate, and mefloquine-artesunate completely cured infections due to Plasmodium falciparum. No effects were found against soil-transmitted helminths and intestinal protozoa. Abdominal pain was the most frequent adverse event, with a higher incidence among children treated with mefloquine (89%), mefloquine-artesunate (83%), and artesunate (60%) than among children treated with praziquantel (46%).

Conclusions: The high efficacy of mefloquine-artesunate against S. haematobium warrants further investigation. Individuals coinfected with Plasmodium and Schistosoma who were treated with a mefloquine-artesunate combination against malaria might have a dual benefit: clearance of malaria parasitemia and reduction of schistosomiasis-related morbidity.

Clinical trials registration: Current Controlled Trials identifier: ISRCTN06498763.

Publication types

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

MeSH terms

  • Abdominal Pain / chemically induced
  • Animals
  • Anthelmintics / administration & dosage*
  • Anthelmintics / adverse effects
  • Artemisinins / administration & dosage*
  • Artemisinins / adverse effects
  • Artesunate
  • Child
  • Drug Therapy, Combination
  • Female
  • Humans
  • Incidence
  • Malaria, Falciparum / parasitology
  • Male
  • Mefloquine / administration & dosage*
  • Mefloquine / adverse effects
  • Parasite Egg Count
  • Plasmodium falciparum / drug effects
  • Praziquantel / administration & dosage*
  • Praziquantel / adverse effects
  • Schistosoma haematobium / drug effects
  • Schistosoma haematobium / isolation & purification
  • Schistosomiasis haematobia / drug therapy*
  • Treatment Outcome

Substances

  • Anthelmintics
  • Artemisinins
  • Artesunate
  • Praziquantel
  • Mefloquine

Associated data

  • ISRCTN/ISRCTN06498763