title: Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children.
abstract: Limiting the duration of antimicrobial treatment constitutes a potential strategy to reduce the risk of antimicrobial resistance among children with acute otitis media.
  
  
  
  We assigned 520 children, 6 to 23 months of age, with acute otitis media to receive amoxicillin-clavulanate either for a standard duration of 10 days or for a reduced duration of 5 days followed by placebo for 5 days. We measured rates of clinical response (in a systematic fashion, on the basis of signs and symptomatic response), recurrence, and nasopharyngeal colonization, and we analyzed episode outcomes using a noninferiority approach. Symptom scores ranged from 0 to 14, with higher numbers indicating more severe symptoms.
  
  
  
  Children who were treated with amoxicillin-clavulanate for 5 days were more likely than those who were treated for 10 days to have clinical failure (77 of 229 children [34%] vs. 39 of 238 [16%]; difference, 17 percentage points [based on unrounded data]; 95% confidence interval, 9 to 25). The mean symptom scores over the period from day 6 to day 14 were 1.61 in the 5-day group and 1.34 in the 10-day group (P=0.07); the mean scores at the day-12-to-14 assessment were 1.89 versus 1.20 (P=0.001). The percentage of children whose symptom scores decreased more than 50% (indicating less severe symptoms) from baseline to the end of treatment was lower in the 5-day group than in the 10-day group (181 of 227 children [80%] vs. 211 of 233 [91%], P=0.003). We found no significant between-group differences in rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin-nonsusceptible pathogens. Clinical-failure rates were greater among children who had been exposed to three or more children for 10 or more hours per week than among those with less exposure (P=0.02) and were also greater among children with infection in both ears than among those with infection in one ear (P<0.001).
  
  
  
  Among children 6 to 23 months of age with acute otitis media, reduced-duration antimicrobial treatment resulted in less favorable outcomes than standard-duration treatment; in addition, neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen. (Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources; ClinicalTrials.gov number, NCT01511107 .).
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Alejandro
authors.initials: A
authors.lastname: Hoberman
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Jack L
authors.initials: JL
authors.lastname: Paradise
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Howard E
authors.initials: HE
authors.lastname: Rockette
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Diana H
authors.initials: DH
authors.lastname: Kearney
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Sonika
authors.initials: S
authors.lastname: Bhatnagar
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Shope
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Judith M
authors.initials: JM
authors.lastname: Martin
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Marcia
authors.initials: M
authors.lastname: Kurs-Lasky
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Copelli
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: D Kathleen
authors.initials: DK
authors.lastname: Colborn
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Stan L
authors.initials: SL
authors.lastname: Block
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: John J
authors.initials: JJ
authors.lastname: Labella
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Lynch
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Norman L
authors.initials: NL
authors.lastname: Cohen
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: MaryAnn
authors.initials: M
authors.lastname: Haralam
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Marcia A
authors.initials: MA
authors.lastname: Pope
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Jennifer P
authors.initials: JP
authors.lastname: Nagg
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Michael D
authors.initials: MD
authors.lastname: Green
authors.affiliation: From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children's Community Pediatrics (J.J.L., T.G.L., N.L.C.) - all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
authors.forename: Nader
authors.initials: N
authors.lastname: Shaikh
mesh_terms: D000208:Acute Disease; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage* / Q000009:adverse effects; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D024881:Drug Resistance, Bacterial; D005260:Female; D006193:Haemophilus influenzae / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D009305:Nasopharynx / Q000382:microbiology; D010033:Otitis Media / Q000188:drug therapy*; D011379:Prognosis; D013296:Streptococcus pneumoniae / Q000302:isolation & purification; D017211:Treatment Failure
chemical_list: D000890:Anti-Infective Agents; D019980:Amoxicillin-Potassium Clavulanate Combination