A randomized controlled trial of amoxicillin plus clavulanate compared with cefaclor for treatment of acute otitis media

Colin D. Marchant; Paul A. Shurin; Candice E. Johnson; D. Murdell-Panek; Joan C. Feinstein; Doris Fulton; Phillip Flexon; Susan A. Carlin; George F. Van Hare

doi:10.1016/S0022-3476(86)80721-1

A randomized controlled trial of amoxicillin plus clavulanate compared with cefaclor for treatment of acute otitis media

Colin D. Marchant, Paul A. Shurin, Candice E. Johnson, D. Murdell-Panek, Joan C. Feinstein, Doris Fulton, Phillip Flexon, Susan A. Carlin, George F. Van Hare

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Abstract

We performed a randomized controlled trial of amoxicillin plus clavulanate versus cefaclor for treatment of acute otitis media. Total daily doses given in three divided doses were 40 mg/kg amoxicillin plus 10 mg/kg clavulanate, and 40 mg/kg cefaclor. Pathogens were eradicated from the middle ear exudate after 3 to 6 days of therapy in 35 (97%) of 36 patients given amoxicillin-clavulanate compared with 24 (75%) of 32 given cefaclor (P=0.028). When analysis was restricted to patients with positive urine or serum drug assays during therapy, pathogens were eliminated in 33 (97%) of 34 patients given amoxicillin-clavulanate compared with 21 (75%) of 28 given cefaclor (P=0.026). Bacterial isolates associated with bacteriologic failure of cefaclor therapy were Streptococcus pneumoniae (two patients), β-lactamase-negative Haemophilus influenzae (four), and β-lactamase-positive Branhamella catarrhalis (two). The single failure with amoxicillin-clavulanate therapy was associated with non-β-lactamase-producing H. influenzae isolated from the middle ear exudate. We conclude that cefaclor is less efficacious than amoxicillin-clavulanate for the treatment of acute otitis media.

Original language	English
Pages (from-to)	891-896
Number of pages	6
Journal	The Journal of Pediatrics
Volume	109
Issue number	5
DOIs	https://doi.org/10.1016/S0022-3476(86)80721-1
State	Published - Nov 1986

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@article{7dad5503a4f94caba2b45bc8b314b93d,

title = "A randomized controlled trial of amoxicillin plus clavulanate compared with cefaclor for treatment of acute otitis media",

abstract = "We performed a randomized controlled trial of amoxicillin plus clavulanate versus cefaclor for treatment of acute otitis media. Total daily doses given in three divided doses were 40 mg/kg amoxicillin plus 10 mg/kg clavulanate, and 40 mg/kg cefaclor. Pathogens were eradicated from the middle ear exudate after 3 to 6 days of therapy in 35 (97%) of 36 patients given amoxicillin-clavulanate compared with 24 (75%) of 32 given cefaclor (P=0.028). When analysis was restricted to patients with positive urine or serum drug assays during therapy, pathogens were eliminated in 33 (97%) of 34 patients given amoxicillin-clavulanate compared with 21 (75%) of 28 given cefaclor (P=0.026). Bacterial isolates associated with bacteriologic failure of cefaclor therapy were Streptococcus pneumoniae (two patients), β-lactamase-negative Haemophilus influenzae (four), and β-lactamase-positive Branhamella catarrhalis (two). The single failure with amoxicillin-clavulanate therapy was associated with non-β-lactamase-producing H. influenzae isolated from the middle ear exudate. We conclude that cefaclor is less efficacious than amoxicillin-clavulanate for the treatment of acute otitis media.",

author = "Marchant, {Colin D.} and Shurin, {Paul A.} and Johnson, {Candice E.} and D. Murdell-Panek and Feinstein, {Joan C.} and Doris Fulton and Phillip Flexon and Carlin, {Susan A.} and {Van Hare}, {George F.}",

note = "Funding Information: Amoxiciilin has remained the most frequently prescribed drug for initial treatment of acute otitis media, but the emergence of /%lactamase-producing organisms such as Haemophilus influenzae ~ and then Branhamella catarrh-alis 2. 3 may change this practice. Alternatives to amoxicillin or other aminopenicillins are (1) non-#-lactam antimicro- Supported by Grant 5 ROI HD18753-02 from the National Institute of Child Health and Human Development and by Grant 84-393-31R from the Cleveland Foundation. Submitted for publication June 2, 1986; accepted July 14, 1986. Reprint requests: Colin D. Marchant, M.D., Department of Pediatrics, St. Boniface General Hospital, 409 Tache Ave., Winnipeg, Manitoba, Canada R2H 2A6.",

year = "1986",

month = nov,

doi = "10.1016/S0022-3476(86)80721-1",

language = "English",

volume = "109",

pages = "891--896",

journal = "The Journal of Pediatrics",

issn = "0022-3476",

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T1 - A randomized controlled trial of amoxicillin plus clavulanate compared with cefaclor for treatment of acute otitis media

AU - Marchant, Colin D.

AU - Shurin, Paul A.

AU - Johnson, Candice E.

AU - Murdell-Panek, D.

AU - Feinstein, Joan C.

AU - Fulton, Doris

AU - Flexon, Phillip

AU - Carlin, Susan A.

AU - Van Hare, George F.

N1 - Funding Information: Amoxiciilin has remained the most frequently prescribed drug for initial treatment of acute otitis media, but the emergence of /%lactamase-producing organisms such as Haemophilus influenzae ~ and then Branhamella catarrh-alis 2. 3 may change this practice. Alternatives to amoxicillin or other aminopenicillins are (1) non-#-lactam antimicro- Supported by Grant 5 ROI HD18753-02 from the National Institute of Child Health and Human Development and by Grant 84-393-31R from the Cleveland Foundation. Submitted for publication June 2, 1986; accepted July 14, 1986. Reprint requests: Colin D. Marchant, M.D., Department of Pediatrics, St. Boniface General Hospital, 409 Tache Ave., Winnipeg, Manitoba, Canada R2H 2A6.

PY - 1986/11

Y1 - 1986/11

N2 - We performed a randomized controlled trial of amoxicillin plus clavulanate versus cefaclor for treatment of acute otitis media. Total daily doses given in three divided doses were 40 mg/kg amoxicillin plus 10 mg/kg clavulanate, and 40 mg/kg cefaclor. Pathogens were eradicated from the middle ear exudate after 3 to 6 days of therapy in 35 (97%) of 36 patients given amoxicillin-clavulanate compared with 24 (75%) of 32 given cefaclor (P=0.028). When analysis was restricted to patients with positive urine or serum drug assays during therapy, pathogens were eliminated in 33 (97%) of 34 patients given amoxicillin-clavulanate compared with 21 (75%) of 28 given cefaclor (P=0.026). Bacterial isolates associated with bacteriologic failure of cefaclor therapy were Streptococcus pneumoniae (two patients), β-lactamase-negative Haemophilus influenzae (four), and β-lactamase-positive Branhamella catarrhalis (two). The single failure with amoxicillin-clavulanate therapy was associated with non-β-lactamase-producing H. influenzae isolated from the middle ear exudate. We conclude that cefaclor is less efficacious than amoxicillin-clavulanate for the treatment of acute otitis media.

AB - We performed a randomized controlled trial of amoxicillin plus clavulanate versus cefaclor for treatment of acute otitis media. Total daily doses given in three divided doses were 40 mg/kg amoxicillin plus 10 mg/kg clavulanate, and 40 mg/kg cefaclor. Pathogens were eradicated from the middle ear exudate after 3 to 6 days of therapy in 35 (97%) of 36 patients given amoxicillin-clavulanate compared with 24 (75%) of 32 given cefaclor (P=0.028). When analysis was restricted to patients with positive urine or serum drug assays during therapy, pathogens were eliminated in 33 (97%) of 34 patients given amoxicillin-clavulanate compared with 21 (75%) of 28 given cefaclor (P=0.026). Bacterial isolates associated with bacteriologic failure of cefaclor therapy were Streptococcus pneumoniae (two patients), β-lactamase-negative Haemophilus influenzae (four), and β-lactamase-positive Branhamella catarrhalis (two). The single failure with amoxicillin-clavulanate therapy was associated with non-β-lactamase-producing H. influenzae isolated from the middle ear exudate. We conclude that cefaclor is less efficacious than amoxicillin-clavulanate for the treatment of acute otitis media.

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JO - The Journal of Pediatrics

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A randomized controlled trial of amoxicillin plus clavulanate compared with cefaclor for treatment of acute otitis media

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