A phase II/III double-blind, dose-finding clinical trial of a combination of mefloquine, sulfadoxine, and pyrimethamine (Fansimef) in falciparum malaria.
Fansimef is a combination of 250 mg mefloquine (base), 500 mg sulfadoxine, and 25 mg pyrimethamine per tablet. One hundred and fifty adult male Brazilian patients at Belém (Pará), who had peripheral blood smears positive for Plasmodium falciparum, with or without clinical symptoms of falciparum malaria, were treated in a double-blind randomized fashion with either one, two or three tablets of Fansimef. Of those receiving one tablet (48 patients), 81% were cured and 19% exhibited RI recrudescences. All the patients receiving two or three tablets of Fansimef (49 patients in each group) were cured. The rates of initial clearance of parasitaemia and fever were similar in all treatment groups. Tolerance was good at all dose levels. The main side-effects included nausea, vomiting, dizziness, diarrhoea and abdominal pain, but these were mild and transient and required no specific treatment. The incidence of vomiting and nausea was highest in patients given the three-tablet dose. The results of various haematological, biochemical and urine analyses were not adversely altered by the administration of Fansimef.
de Souza
J M
JM
Sheth
U K
UK
Wernsdorfer
W H
WH
Trigg
P I
PI
Doberstyn
E B
EB
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000818:Animals; D000962:Antimalarials / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001938:Brazil; D004311:Double-Blind Method; D004338:Drug Combinations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004341:Drug Evaluation; D006801:Humans; D008288:Malaria / Q000188:drug therapy*; D008297:Male; D015767:Mefloquine / Q000031:analogs & derivatives*; D008875:Middle Aged; D010963:Plasmodium falciparum; D011739:Pyrimethamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011804:Quinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011897:Random Allocation; D013413:Sulfadoxine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013424:Sulfanilamides / Q000627:therapeutic use*; D000096926:Benzenesulfonamides
D000962:Antimalarials; D004338:Drug Combinations; D015767:Mefloquine; D011739:Pyrimethamine; D011804:Quinolines; D013413:Sulfadoxine; D013424:Sulfanilamides; C046846:mefloquine-sulfadoxine-pyrimethamine; D000096926:Benzenesulfonamides