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A placebo-controlled trial of

antimicrobial treatment for acute OtitisMedia

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Abstract

• Backgound

 The ecacy antimicrobial treatment inchildren with acute otitis mediaremains controversial

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• Methods

- In this randmied! doubel-blind trial"

#hildren $%-&' months( with acute otitis media!diagnosed with the use of strict criteria"

Amoxicillin-clavulanate (161 children)

Placebo (158 children) for ) days"

- the primary outcome was the time totreatment failure from the *st does until theend of treatment on day +

-

 Treatment failure, condition of the child$including adverse events( and otoscopic signof acute otitis media"

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• esult

-  Treatment failure occured in *+"%. ofthe children who receivedamo/icillin-clavulanate! as comparedwith 00"1. of the children who

received placebo"-  The di2erence between the groups

was already apparent at the *st

schedule visit $day &(! at which time*&"). of the children receivedamo/icillin-clavulanate! as compared

with 3'"&. received placebo! had

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- Over all! amo/icillin-clavulanate reduced the

progression to treatment failure by %3. and

the need for rescue treatment by +*."- Analgesic4antipyretic agents were given to

+0"3. and +'"1. of the children in theamo/icillin-clavulanate and placebo groups!respectively"

- Adverse events were signi5cantly morecommon in the amo/icillin-clavulanate grouphad diarrhea! as compared with 3%"%. in thepacebo group $678"88*(9 +"). and &"3. ofthe children in the respective groups hadecema

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• #onclusions

-

#hildren with acute otitis mediabene5t from antimicrobial trreatmentas compared with placebo! althoughtthey have more side e2ect"

- :uture studies should identifypatients who may derive the greatestbene5t! in order to minimie

unnecessary antimicrobial treatmentand the development of bacterialresistance"

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• Acute otitis media is the mostcommon bacterial infection duringearly chidhood"

• Because the treatment of aute otitismedia is ma;or reason for the use ofthe antimicrobial agents in the

outpatient setting! e/perts havecalled for these agents to be used

 ;udiciously"

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•