title: Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh: an open-label randomized, controlled clinical trial.
abstract: 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.
authors.affiliation: Department of Specific Prophylaxes and Tropical Medicine, Medical University of Vienna, Austria.
authors.forename: Kamala
authors.initials: K
authors.lastname: Thriemer
authors.forename: Peter
authors.initials: P
authors.lastname: Starzengruber
authors.forename: Wasif Ali
authors.initials: WA
authors.lastname: Khan
authors.forename: Rashidul
authors.initials: R
authors.lastname: Haque
authors.forename: Aung Swe Prue
authors.initials: AS
authors.lastname: Marma
authors.forename: Benedikt
authors.initials: B
authors.lastname: Ley
authors.forename: Matthias G
authors.initials: MG
authors.lastname: Vossen
authors.forename: Paul
authors.initials: P
authors.lastname: Swoboda
authors.forename: Jasmin
authors.initials: J
authors.lastname: Akter
authors.forename: Harald
authors.initials: H
authors.lastname: Noedl
mesh_terms: 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
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004983:Ethanolamines; D005449:Fluorenes; D000077332:Artesunate; D017963:Azithromycin; D000077549:Artemether; D000078102:Lumefantrine