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Clinical Trial
. 2000 Jan;44(1):43-50.
doi: 10.1128/AAC.44.1.43-50.2000.

Bacteriologic efficacies of oral azithromycin and oral cefaclor in treatment of acute otitis media in infants and young children

R Dagan  1 , E Leibovitz, D M Fliss, A Leiberman, M R Jacobs, W Craig, P Yagupsky
Affiliations
Clinical Trial

Bacteriologic efficacies of oral azithromycin and oral cefaclor in treatment of acute otitis media in infants and young children

R Dagan et al. Antimicrob Agents Chemother. 2000 Jan.

Abstract

A prospective, open-label, randomized study was conducted in order to determine the bacteriologic efficacies of cefaclor and azithromycin in acute otitis media (AOM). Tympanocentesis was performed on entry into the study and 3 to 4 days after initiation of treatment. Bacteriologic failure after 3 to 4 days of treatment with both drugs occurred in a high proportion of culture-positive patients, especially in those in whom AOM was caused by Haemophilus influenzae (16 of 33 [53%] of those treated with azithromycin and 13 of 34 [52%] of those treated with cefaclor). Although a clear correlation of the persistence of the pathogen with increased MICs of the respective drugs could be demonstrated for Streptococcus pneumoniae, no such correlation was found for H. influenzae. It is proposed that susceptibility breakpoints for H. influenzae should be considerably lower than the current ones for both cefaclor and azithromycin for AOM caused by H. influenzae.

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Figures

FIG. 1
FIG. 1
Comparison of E-test and microdilution MICs for 40 H. influenzae isolates. MIC50 and MIC90, MICs at which 50 and 90% of isolates are inhibited, respectively.
FIG. 2
FIG. 2
Flow chart of the study. A total of 138 patients were enrolled, and 122 were evaluable.
FIG. 3
FIG. 3
Cumulative distribution of MICs of various drugs for initial isolates of S. pneumoniae (n = 51) and H. influenzae (n = 64). Pen, Penicillin (tested by the E-test); Cec, cefaclor (tested by the E-test); Az, azithromycin (tested by the microdilution method for S. pneumoniae and the E-test for H. influenzae); ∗, the azithromycin MICs for three strains were not tested by the microdilution method, and thus, data for these strains were excluded from this comparison.
FIG. 4
FIG. 4
(A) Bacteriologic failure rate according to MICs for S. pneumoniae in patients with AOM treated with azithromycin (n = 18) or cefaclor (n = 33). (B) Bacteriologic failure rate according to MICs for H. influenzae in patients with AOM treated with azithromycin (n = 35) or cefaclor (n = 29). CEC, cefaclor; AZ, azithromycin. □, cure; ■, failure.
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Comment in

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