Comparative study of the effectiveness and pharmacokinetics of two rectal artesunate/oral mefloquine combination regimens for the treatment of uncomplicated childhood falciparum malaria.
BACKGROUND
Rectal artesunate has been shown to be an effective treatment for falciparum malaria and is useful in patients who cannot take medicine orally or when parenteral medication is inconvenient. A combination with mefloquine can decrease the duration of treatment, increase compliance and delay development of resistance. There are no clear data on whether a higher dosage of rectal artesunate results in a better clinical response.


OBJECTIVE
To assess two rectal artesunate/oral mefloquine regimens for treating uncomplicated multi-drug-resistant childhood falciparum malaria.


METHODS
Seventy children aged 1-14 years with uncomplicated falciparum malaria were randomly assigned to receive either 10 (range 8-12) or 20 (range 16-24) mg/kg/day rectal artesunate for 3 days followed by 25 mg/kg oral mefloquine. The study endpoints were fever clearance time, parasite clearance time and proportion of patients with recrudescence. Serum levels of artesunate and dihydro-artemisinin were measured after the first dose of rectal artesunate in 16 subjects.


RESULTS
Both regimens were safe and effective. The cure rate was 100% in the 53 patients who completed 28-day follow-up. All of the study endpoints were comparable between both treatment groups.


CONCLUSIONS
A regimen of rectal artesunate 10 mg/kg/day for 3 days followed by mefloquine 25 mg/kg is optimal for the treatment of uncomplicated falciparum malaria. There was no definite benefit from increasing the dosage of rectal artesunate from 10 to 20 mg/kg/day.
Sirivichayakul
Chukiat
C
Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, 420/6 Rachawithi Road, Bangkok 10400, Thailand. tmcsw@mahidol.ac.th
Sabchareon
Arunee
A
Pengsaa
Krisana
K
Thaiarporn
Itthipon
I
Chaivisuth
Anong
A
Na-Bangchang
Kesara
K
Wisetsing
Pataraporn
P
Chanthavanich
Pornthep
P
Pojjaroen-Anant
Chanathep
C
D000284:Administration, Oral; D000285:Administration, Rectal; D000293:Adolescent; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D000077332:Artesunate; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000097:blood / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D015767:Mefloquine / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D012717:Sesquiterpenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D016037:Single-Blind Method; D016896:Treatment Outcome
D000962:Antimalarials; D037621:Artemisinins; D012717:Sesquiterpenes; D000077332:Artesunate; D015767:Mefloquine