Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh: an open-label randomized, controlled clinical trial.
BACKGROUND
In recent studies, the combination of azithromycin and artesunate has proven to be a promising alternative for the treatment of uncomplicated falciparum malaria.


METHODS
We conducted a randomized, controlled clinical trial assessing the efficacy of azithromycin-artesunate combination therapy. The study was conducted involving 228 patients aged 8-65 years. Patients were randomized to 1 of 2 cohorts at a ratio of 2:1, receiving either azithromycin-artesunate once daily for 3 days (30 mg/kg per day of azithromycin plus 4 mg/kg per day of artesunate) or an adult dose of 80 mg of artemether plus 960 mg of lumefantrine (4 tablets Coartem or the equivalent for children weighing <35 kg) twice daily for 3 days.


RESULTS
The 42-day cure rate by Kaplan-Meier analysis was 94.6% (95% confidence interval [CI], 89.38%-97.44%) in the azithromycin-artesunate arm and 97.0% (95% CI, 89.45%-99.40%) in the control arm. Fever clearance times and parasite clearance times did not show any differences between the 2 arms (P=.59 and .95, respectively). No serious adverse events were seen, but the percentage of patients who developed any adverse event was higher in the control group (P=.03).


CONCLUSIONS
Our data suggest that azithromycin-artesunate is an efficacious and well-tolerated treatment for patients with uncomplicated falciparum malaria in Bangladesh.
Thriemer
Kamala
K
Department of Specific Prophylaxes and Tropical Medicine, Medical University of Vienna, Austria.
Starzengruber
Peter
P
Khan
Wasif Ali
WA
Haque
Rashidul
R
Marma
Aung Swe Prue
AS
Ley
Benedikt
B
Vossen
Matthias G
MG
Swoboda
Paul
P
Akter
Jasmin
J
Noedl
Harald
H
D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D000077549:Artemether; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects; D000077332:Artesunate; D017963:Azithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D001459:Bangladesh; D002648:Child; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage; D006801:Humans; D000078102:Lumefantrine; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018512:Parasitemia / Q000188:drug therapy; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000962:Antimalarials; D037621:Artemisinins; D004983:Ethanolamines; D005449:Fluorenes; D000077332:Artesunate; D017963:Azithromycin; D000077549:Artemether; D000078102:Lumefantrine