Mefloquine versus quinine plus sulphalene-pyrimethamine (metakelfin) for treatment of uncomplicated imported falciparum malaria acquired in Africa.
We conducted a multicenter, randomized, open-label trial to compare mefloquine with a 3-day quinine plus sulphalene-pyrimethamine (SP) regimen for the treatment of imported uncomplicated malaria acquired in Africa. The end points of the study were efficacy, tolerability, and length of hospital stay. From July 1999 to February 2003, 187 patients were enrolled in five centers in Italy, of whom 93 were randomized to receive mefloquine (the M group) and 94 were randomized to receive quinine plus SP (the QSP group). Immigrants and visiting relatives and friends represented 90% of the cases and were mainly from western African countries. A slightly increased proportion of cases in the QSP group had abnormal alanine aminotransferase levels at the baseline. The early cure rate was similar in the two groups: 98.9% (confidence interval [CI] = 97 to 100%) in the M group and 96.8% (CI = 93 to 100%) in the QSP group. The extended follow-up was completed by 135 subjects (72.2%), and no case of recrudescence was detected. There were no differences in the parasite clearance time, but patients in the M group had shorter mean fever clearance time (35.9 h versus 44.4 h for the QSP group; P = 0.05) and a shorter mean hospital stay (3.9 days versus 4.6 days for the QSP group; P = 0.007). The overall proportions of reported side effects were similar in the two groups, but patients in the M group had a significantly higher rate of central nervous system disturbances (29.0% versus 9.6% for the QSP group; P < 0.001).
Matteelli
Alberto
A
Institute of Infectious and Tropical Diseases, University of Brescia, Brescia 25125, Italy. amatteelli@bsnet.it
Saleri
Nuccia
N
Bisoffi
Zeno
Z
Gregis
Giampietro
G
Gaiera
Giovanni
G
Visonà
Raffaella
R
Tedoldi
Simona
S
Scolari
Carla
C
Marocco
Stefania
S
Gulletta
Maurizio
M
D000328:Adult; D000349:Africa; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D015767:Mefloquine / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D011739:Pyrimethamine / Q000009:adverse effects / Q000627:therapeutic use*; D011803:Quinine / Q000009:adverse effects / Q000627:therapeutic use*; D013415:Sulfalene / Q000009:adverse effects / Q000627:therapeutic use*
D000962:Antimalarials; D004338:Drug Combinations; C050416:metakelfin; D011803:Quinine; D013415:Sulfalene; D015767:Mefloquine; D011739:Pyrimethamine