Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in bangladesh: An open-label randomized, controlled clinical trial

Kamala Ley-Thriemer, Peter Starzengrüber, Wasif Khan, Rashidul Haque, Aung Swe Prue Marma, Benedikt Ley, Matthias Vossen, Paul Swoboda, Jasmin Akter, Harald Noedl

    Research output: Contribution to journalArticle

    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.

    Method: 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.

    Trial Registration: ClinicalTrials.gov identifier: NCT00356005.

    Original languageEnglish
    Pages (from-to)392-398
    Number of pages7
    JournalJournal of Infectious Diseases
    Volume202
    Issue number3
    DOIs
    Publication statusPublished - 1 Aug 2010

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