A simplified intravenous artesunate regimen for severe malaria.
J Infect Dis
; 205(2): 312-9, 2012 Jan 15.
Article
in En
| MEDLINE
| ID: mdl-22180622
ABSTRACT
BACKGROUND:
We compared a conventional empirically derived regimen with a simplified regimen for parenteral artesunate in severe malaria.METHODS:
This was a randomized, double-blind, placebo-controlled comparison to assess the noninferiority of a simplified 3-dose regimen (given at 0, 24, and 48 hours) compared with the conventional 5-dose regimen of intravenous artesunate (given at 0, 12, 24, 48, and 72 hours) in African children with Plasmodium falciparum malaria with a prespecified delta of 0.2. The total dose of artesunate in each group was 12 mg/kg. The primary end point was the proportion of children clearing ≥ 99% of their admission parasitemia at 24 hours. Safety data, secondary efficacy end points, and pharmacokinetics were also analyzed.RESULTS:
In 171 children (per protocol), 78% of the recipients (95% confidence interval [CI], 69%-87%) in the 3-dose group achieved ≥ 99% parasite clearance 24 hours after the start of treatment, compared with 85% (95% CI, 77%-93%) of those receiving the conventional regimen (treatment difference, -7.2%; 95% CI, -18.9% to 4.4%). Dihydroartemisinin was cleared slightly more slowly in those children receiving the higher 3-dose regimen (7.4 vs 8.8 L/h for a 13-kg child; P 5 .008).CONCLUSIONS:
Pharmacodynamic analysis suggests that 3 doses of artesunate were not inferior to 5 doses for the treatment of severe malaria in children. CLINICAL TRIALS REGISTRATION NCT00522132.
Full text:
1
Database:
MEDLINE
Main subject:
Malaria, Falciparum
/
Artemisinins
/
Parasite Load
/
Antimalarials
Type of study:
Clinical_trials
/
Guideline
Limits:
Child
/
Child, preschool
/
Female
/
Humans
/
Male
Language:
En
Journal:
J Infect Dis
Year:
2012
Type:
Article
Affiliation country:
Germany