Efficacy/safety of amoxicillin/clavulanate in adults with bacterial rhinosinusitis
Jack B Anon1, Elchonon Berkowitz, John Breton
1Department of Otolaryngology, University of Pittsburgh College of Medicine, Erie, PA 16508, USA. janonmd@velocity.net
Purpose:
Acute bacterial rhinosinusitis (ABRS) is a common and uncomfortable condition, frequently caused by Streptococcus pneumoniae or Haemophilus influenzae. Antibacterial resistance among these and other common respiratory pathogens is now widespread and of concern. Pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg was developed to be effective against the common respiratory pathogens, including many resistant strains.
Materials And Methods:
This open-label, noncomparative study assessed the bacteriologic and clinical efficacy of amoxicillin/clavulanate 2000/125 mg in adult patients with ABRS. Requirements for study entry included a clinical diagnosis of ABRS supported by radiologic findings. In addition, sinus puncture for bacteriologic assessment was required at study entry.
Results:
Overall, bacteriologic success (eradication or clinical evidence of eradication) at the follow-up visit (days 17-28) was achieved in 87.8% (722/822) of patients with 1 or more pathogen isolated at screening, in 93.2% (246/264) of patients with S pneumoniae, in 96.7% (29/30) of those with penicillin-resistant S pneumoniae (penicillin minimum inhibitory concentrations >or=2 microg/mL), and in 88.7% (110/124) of patients with beta-lactamase-positive pathogens. Bacteriologic success was achieved against 6 of 7 S pneumoniae isolates with amoxicillin/clavulanic acid minimum inhibitory concentrations of 4/2 microg/mL or higher.
Conclusions:
Amoxicillin/clavulanate 2000/125 mg was generally well tolerated. This new amoxicillin/clavulanate formulation provides a suitable option for empiric therapy for ABRS in adults.
Insights
This study shows that amoxicillin/clavulanate 2000/125 mg effectively treats acute bacterial rhinosinusitis (ABRS), even against resistant strains. The enhanced formulation offers a good option for adult ABRS patients.
Area of Science:
- Infectious Diseases
- Pharmacology
- Otolaryngology
Background:
- Acute bacterial rhinosinusitis (ABRS) is a common condition often caused by Streptococcus pneumoniae and Haemophilus influenzae.
- Increasing antibacterial resistance in respiratory pathogens is a significant clinical concern.
- A novel pharmacokinetically enhanced amoxicillin/clavulanate formulation (2000/125 mg) was developed to address resistant strains.
Purpose of the Study:
- To assess the bacteriologic and clinical efficacy of amoxicillin/clavulanate 2000/125 mg in adult patients diagnosed with ABRS.
- To evaluate the effectiveness of this enhanced formulation against common respiratory pathogens, including resistant strains.
Main Methods:
- An open-label, noncomparative study design was employed.
- Adult patients with clinically and radiologically confirmed ABRS were enrolled.
- Sinus puncture was performed at study entry for bacteriologic assessment.
Main Results:
- Bacteriologic success was achieved in 87.8% of patients with isolated pathogens.
- High success rates were observed against Streptococcus pneumoniae (93.2%) and penicillin-resistant S. pneumoniae (96.7%).
- Effectiveness was also demonstrated against beta-lactamase-positive pathogens (88.7%).
Conclusions:
- Amoxicillin/clavulanate 2000/125 mg was well-tolerated in the study population.
- This enhanced formulation represents a viable therapeutic option for empiric treatment of ABRS in adults.
- The study supports the use of this formulation in managing ABRS, considering rising antimicrobial resistance.
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