48899
document
Treatment of acute otitis media in children under 2 years of age . BACKGROUND Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media . METHODS We randomly assigned 291 children 6 to 23 months of age , with acute otitis media diagnosed with the use of stringent criteria , to receive amoxicillin-clavulanate or placebo for 10 days . We measured symptomatic response and rates of clinical failure . RESULTS Among the children who received amoxicillin-clavulanate , 35 % had initial resolution of symptoms by day 2 , 61 % by day 4 , and 80 % by day 7 ; among children who received placebo , 28 % had initial resolution of symptoms by day 2 , 54 % by day 4 , and 74 % by day 7 ( P=0.14 for the overall comparison ) . For sustained resolution of symptoms , the corresponding values were 20 % , 41 % , and 67 % with amoxicillin-clavulanate , as compared with 14 % , 36 % , and 53 % with placebo ( P=0.04 for the overall comparison ) . Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo ( P=0.02 ) . The rate of clinical failure -- defined as the persistence of signs of acute infection on otoscopic examination -- was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo : 4 % versus 23 % at or before the visit on day 4 or 5 ( P < 0.001 ) and 16 % versus 51 % at or before the visit on day 10 to 12 ( P < 0.001 ) . Mastoiditis developed in one child who received placebo . Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate . There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae . CONCLUSIONS Among children 6 to 23 months of age with acute otitis media , treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination . ( Funded by the National Institute of Allergy and Infectious Diseases ; ClinicalTrials.gov number , NCT00377260 . ) .
48900
Intervention_Pharmacological
immediate antimicrobial treatment
48901
Intervention_Physical
watchful waiting
48902
Intervention_Pharmacological
amoxicillin-clavulanate
48903
Intervention_Control
placebo
48904
Intervention_Pharmacological
amoxicillin-clavulanate
48905
Intervention_Control
placebo
48906
Intervention_Pharmacological
amoxicillin-clavulanate
48907
Intervention_Control
placebo
48908
Intervention_Pharmacological
amoxicillin-clavulanate
48909
Intervention_Control
placebo
48910
Intervention_Pharmacological
amoxicillin-clavulanate
48911
Intervention_Control
placebo
48912
Intervention_Control
placebo
48913
Intervention_Pharmacological
amoxicillin-clavulanate
48914
Intervention_Pharmacological
amoxicillin-clavulanate
48915
Outcome_Physical
symptomatic response
48916
Outcome_Physical
rates of clinical failure
48917
Outcome_Physical
initial resolution of symptoms
48918
Outcome_Physical
Mean symptom scores
48919
Outcome_Physical
rate of clinical failure -- defined
48920
Outcome_Physical
acute infection on otoscopic examination
48921
Outcome_Adverse-effects
Mastoiditis
48922
Outcome_Adverse-effects
Diarrhea and diaper-area dermatitis
48923
Outcome_Physical
nasopharyngeal colonization
48924
Participant_Condition
acute otitis media in children under 2 years of age .