Efficacy/safety of amoxicillin/clavulanate in adults with bacterial rhinosinusitis.
OBJECTIVE
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.


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.
Anon
Jack B
JB
Department of Otolaryngology, University of Pittsburgh College of Medicine, Erie, PA 16508, USA. janonmd@velocity.net
Berkowitz
Elchonon
E
Breton
John
J
Twynholm
Monique
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D024881:Drug Resistance, Bacterial; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010403:Penicillin Resistance; D011008:Pneumococcal Infections / Q000188:drug therapy; D011859:Radiography; D012220:Rhinitis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000382:microbiology; D012852:Sinusitis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000382:microbiology; D013296:Streptococcus pneumoniae
D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination