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.
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 language | English |
|---|---|
| Pages (from-to) | 392-398 |
| Number of pages | 7 |
| Journal | Journal of Infectious Diseases |
| Volume | 202 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 1 Aug 2010 |
| Externally published | Yes |