Efficacy and Safety of Azithromycin 1 g Once Daily for 3 Days in the Treatment of Community-Acquired Pneumonia: an Open-Label Randomised Comparison with Amoxicillin-Clavulanate 875/125 mg Twice Daily for 7 Days

Abstract

This randomised, open-label, non-inferiority study was designed to demonstrate that a 3-day course of oral azithromycin 1 g once daily was at least as effective as a standard 7-day course of oral amoxicillin-clavulanate 875/125 mg twice daily in the treatment of outpatients with community-acquired pneumonia (Fine class I and II). In total, 267 patients with clinically and radiologically confirmed community-acquired pneumonia were randomly assigned to receive either the azithromycin (n=136) or the amoxicillin-clavulanate (n=131) regimen. At screening, 60/136 (58.8%) and 61/131 (62.9%) respectively had at least one pathogen identified by sputum culture, PCR, or serology. The primary endpoint was the clinical response in the intent-to-treat population at the end of therapy (day 8 to 12). Clinical success rates were 126/136 (92.6%) for azithromycin and 122/131 (93.1%) for amoxicillin-clavulanate (treatment difference: - 0.48%; 95% confidence interval: - 5.66%; 4.69%). Clinical and radiological success rates at follow-up (day 22-26) were consistent with the end of therapy results, no patient reporting clinical relapse. Bacteriological success rates at the end of therapy were 32/35 (91.4%) for azithromycin and 30/33 (90.9%) for amoxicillin-clavulanate (treatment difference: 0.52%; 95% confidence interval - 10.81%; 11.85%). Both treatment regimens were well tolerated: the overall incidence of adverse events was 34/136 (25.0%) for azithromycin and 22/132 (16.7%) for amoxicillin-clavulanate. In both treatment groups, the most commonly reported events were gastrointestinal symptoms. Azithromycin 1g once daily for 3 days is at least as effective as amoxicillin-clavulanate 875/125 mg twice daily for 7 days in the treatment of adult patients with community-acquired pneumonia.

The Fitness Cost of Antibiotic Resistance in Streptococcus pneumoniae: Insight from the Field

“…The cure rate for erm B strains was estimated to be near-zero by this method, but was also set to 5% to avoid introducing an ab initio difference between the two strains. The cure rate was estimated to be 88% for the antibiotic-sensitive strain, by extrapolating estimated treatment efficacies of around 93% from studies that used higher doses of azithromycin, but in populations that presumably harbored resistance [30], [31].…”

Guidelines for diagnosis and management of community-and hospital-acquired pneumonia in adults: Joint ICS/NCCP(I) recommendations

“…[17161] Various studies have shown results favoring different groups of antibiotics [Table 7]. [165–169171–174178–184] The evidence does not support the choice of any particular antibiotic since individual study results do not reveal significant differences in efficacy between various antibiotics and antibiotic groups. [175] The commonly used antibiotics are either β-lactams or macrolides.…”

Participation of Elderly Adults in Randomized Controlled Trials Addressing Antibiotic Treatment of Pneumonia

“…The search for RCTs yielded 5,495 titles. After applying inclusion and exclusion criteria, 43 RCTs were included in the final analysis (Figure ): two trials of CAP‐C; three of mixed CAP‐C and CAP‐H, 20 of CAP‐H, two of mixed CAP‐H and HCAP, three of HCAP, six of HAP, five of VAP, and two of HAP and VAP . Two CAP‐H trials targeted a priori an elderly population …”