Randomised controlled trial of sequential intravenous and oral azithromycin compared with intravenous ceftriaxone followed by cefixime both in combination with clarithromycin in hospitalized patients with community-acquired pneumonia

The objective of the study was to compare the efficacy, safety, and tolerability of Azithromycin (500 mg) intravenously (i.v.) once daily followed by 250 mg orally twice daily for 14 days with Ceftriaxone (2 g) by i.v. infusion twice daily followed by Cefixime (400 mg) twice daily, both in combination with oral clarithromycin (500 mg) twice daily for the same duration in 63 adult patients initialy hospitalized with community-acquired pneumonia. All patients assessed both clinically and bacteriologically one month after the end of treatment. The results showed statistically significant higher clinical (93.4% vs. 85.4%) and bacteriological success rates (93.7% vs. 81.7%) for patients treated with Azithromycin, irrespective of the severity of the pneumonia. The time to resolution of fever was also faster (median time: 2 vs. 3 days) and hospitalization period was approximately 1 day less for patients who received Azithromycin. The treatment was converted to oral therapy immediately after the initial mandatory 3-day period of i.v.administration for a larger proportion of patients in the Azithromycin group than patients in the control group (50.2% vs. 17.8%). There were fewer deaths (3.0% vs. 5.3%) and fewer serious adverse events (12.6% vs. 16.5%) in the Azithromycin group than in the control group. The rates of drug-related adverse events were comparable in both groups. Thus, monotherapy with Azithromycin is superior to combination regimen of ceftriaxone plus clarithromycin, in the treatment of community-acquired pneumonia.