Bacteriologic and clinical efficacy of amoxicillin/clavulanate vs. azithromycin in acute otitis media.
OBJECTIVE
To compare the bacteriologic and clinical efficacy of amoxicillin/clavulanate and azithromycin in patients with acute otitis media (AOM), particularly the ability to eradicate the predominant AOM pathogens from middle ear fluid as assessed by mandatory second tympanocentesis.


METHODS
In this single blind study 238 infants and children with AOM were randomized to receive amoxicillin/clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) or azithromycin (10 mg/kg on Day 1, then 5 mg/kg daily on Days 2 through 5). Tympanocentesis was performed before the first dose and repeated on Day 4, 5 or 6. Clinical response was assessed at end of therapy between Days 12 and 14 and at follow-up between Days 22 and 28.


RESULTS
Amoxicillin/clavulanate was significantly more likely to eradicate all bacterial pathogens [83% (54 of 65) vs. 49% (35 of 71), P = 0.001] and Haemophilus influenzae [87% (26 of 30) vs. 39% (13 of 33), P = 0.0001] from middle ear fluid than was azithromycin. Amoxicillin/clavulanate was also more likely to eradicate Streptococcus pneumoniae, but the difference was not statistically significant [90% (18 of 20) vs. 68% (13 of 19) [corrected], P = 0.095]. On Days 12 to 14, signs and symptoms were more likely to resolve completely or improve in all culture-positive patients [86% (60 of 70) vs. 70% (51 of 73), P = 0.023] and in those with H. influenzae infections [91% (30 of 33) vs. 65% (22 of 34), P = 0.010] who received amoxicillin/clavulanate compared with those who received azithromycin. Otherwise there were no significant differences between groups in clinical outcomes on Days 12 to 14 or at follow-up.


CONCLUSIONS
Our findings indicate that amoxicillin/clavulanate has superior bacteriologic and clinical efficacy compared with azithromycin in children with AOM.
Dagan
R
R
Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. rdagan@bgumail.bgu.ac.il
Johnson
C E
CE
McLinn
S
S
Abughali
N
N
Feris
J
J
Leibovitz
E
E
Burch
D J
DJ
Jacobs
M R
MR
D019980:Amoxicillin-Potassium Clavulanate Combination / Q000494:pharmacology / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D017963:Azithromycin / Q000494:pharmacology / Q000627:therapeutic use*; D002675:Child, Preschool; D005260:Female; D006193:Haemophilus influenzae / Q000187:drug effects; D006801:Humans; D007223:Infant; D008297:Male; D008826:Microbial Sensitivity Tests; D001936:Moraxella catarrhalis / Q000187:drug effects; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000382:microbiology*; D010406:Penicillins / Q000494:pharmacology; D016037:Single-Blind Method; D013296:Streptococcus pneumoniae / Q000187:drug effects; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D010406:Penicillins; D019980:Amoxicillin-Potassium Clavulanate Combination; D017963:Azithromycin