From the FDA Drug Label
In a randomized, double blind, double-dummy controlled clinical trial of acute bacterial sinusitis, azithromycin (500 mg once daily for 3 days) was compared with amoxicillin/clavulanate (500/125 mg tid for 10 days). The primary endpoint of this trial was prospectively defined as the clinical cure rate at Day 28 For the 594 patients analyzed in the modified intent to treat analysis at the Day 10 visit, the clinical cure rate for 3 days of azithromycin was 88% (268/303) compared to 85% (248/291) for 10 days of amoxicillin/clavulanate. For the 586 patients analyzed in the modified intent to treat analysis at the Day 28 visit, the clinical cure rate for 3 days of azithromycin was 71. 5% (213/298) compared to 71.5% (206/288), with a 97.5% confidence interval of –8.4 to 8. 3, for 10 days of amoxicillin/clavulanate. In the safety analysis of this study, the overall incidence of treatment-related adverse events, primarily gastrointestinal, was lower in the azithromycin treatment arm (31%) than in the amoxicillin/clavulanate arm (51%).
The interaction between Azithromycin and Amoxicillin/Clavulanate (Augmentin) is that they can be alternatives for the treatment of acute bacterial sinusitis, with azithromycin having a lower incidence of treatment-related adverse events compared to amoxicillin/clavulanate 1. Key points:
- Azithromycin and amoxicillin/clavulanate have comparable clinical cure rates at Day 28.
- Azithromycin has a lower incidence of gastrointestinal side effects compared to amoxicillin/clavulanate.
From the Research
Interaction between Azithromycin and Amoxicillin/Clavulanate (Augmentin)
- The interaction between Azithromycin and Amoxicillin/Clavulanate (Augmentin) has been studied in various clinical trials, with a focus on their efficacy and safety in treating acute lower respiratory tract infections, acute sinusitis, and other infections 2, 3, 4, 5, 6.
- A study published in 1997 found that a 3-day regimen of azithromycin was as clinically and microbiologically effective as a 10-day regimen of co-amoxiclav in the treatment of acute lower respiratory tract infections 2.
- Another study published in 2015 compared the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid in the treatment of acute lower respiratory tract infections, and found that azithromycin was more effective in terms of lower incidence of treatment failure and adverse events in patients with acute bronchitis of a suspected bacterial cause 3.
- A study published in 1995 found that amoxicillin/clavulanic acid was more effective than azithromycin in the treatment of acute purulent exacerbation of chronic bronchitis, with an overall efficacy rate of 97.3% compared to 67.6% for azithromycin 4.
- A study published in 1999 found that a 3-day course of azithromycin was as effective and well tolerated as a 10-day course of amoxicillin/clavulanic acid in the treatment of acute sinusitis in adults 5.
- A study published in 1998 compared the clinical effectiveness of azithromycin, amoxicillin/clavulanic acid, and cefaclor in the treatment of acute ear, nose, and throat infections, and found that azithromycin was faster and more effective clinically and analytically than standard treatment with amoxicillin/clavulanic acid or cefaclor 6.
Efficacy and Safety
- The efficacy and safety of azithromycin and amoxicillin/clavulanic acid have been compared in various studies, with mixed results 2, 3, 4, 5, 6.
- Azithromycin has been found to be more effective in terms of lower incidence of treatment failure and adverse events in patients with acute bronchitis of a suspected bacterial cause 3.
- Amoxicillin/clavulanic acid has been found to be more effective than azithromycin in the treatment of acute purulent exacerbation of chronic bronchitis 4.
- Both azithromycin and amoxicillin/clavulanic acid have been found to be well tolerated, with few adverse events reported 2, 3, 4, 5, 6.
Microbiological Efficacy
- The microbiological efficacy of azithromycin and amoxicillin/clavulanic acid has been compared in various studies, with mixed results 2, 3, 4, 5, 6.
- Azithromycin has been found to be effective against a range of pathogens, including Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis 2, 3.
- Amoxicillin/clavulanic acid has also been found to be effective against a range of pathogens, including Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis 2, 4.