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.

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.

Multicentre clinical and bacteriological study of sulbenicillin in patients with bronchopulmonary infection.

In view of the pharmacodynamic and therapeutic properties of a broad-spectrum semisynthetic penicillin recently introduced in Italy, namely sulbenicillin, the authors conducted a multicentre clinical and bacteriological trial of the drug administered by intramuscular or intravenous injection in daily doses of 4, 6 or 8 g given in two or three administrations daily to a group of 66 patients with acute bronchopulmonary infection, mainly exacerbation of chronic infection, hospitalized in four Pneumology Centres of Sardinia. The authors assessed clinical, radiological, microbiological, and biohumoral parameters before and after treatment to provide a basis for assessing test product effectiveness and tolerability. On the strength of their findings, the authors concluded that the clinical and bacteriological activity of sulbenicillin was satisfactory and its local and general tolerability was excellent. The assembled findings indicate that the new antibiotic molecule can be used to advantage in the treatment of nontubercular bronchopulmonary infections, including severe or otherwise "difficult" cases, providing that the drug is administered at adequate dosages and for sufficiently long treatment periods.