EFFICACY OF ANTIMICROBIAL PROPHYLAXIS FOR RECURRENT MIDDLE-EAR EFFUSION

Objectives. This trial compared the efficacy of amoxicillin prophylaxi s with that of placebo for the management of recurrent middle ear effu sion (MEE) in children. Methods. Children between 7 months and 12 year s of age who were effusion-free at entry but had histories of chronic or recurrent MEE were randomly assigned to receive either amoxicillin (20 mg/kg once daily) or placebo for 1 year, They were examined monthl y and when there were symptoms of ear, nose or throat disease, Acute o titis media (AOM) and new episodes of otitis media with effusion (OME) were treated with amoxicillin-clavulanate; tympanocentesis was perfor med when possible for episodes of AOM, Throat cultures were obtained a t entry; 4, 8 and 12 months after entry; and with new episodes of AOM and OME. Tympanometry was performed at each visit and audiometry was p erformed at entry and 4, 8 and 12 months after entry. Results. One hun dred eleven children were entered in this study, The rates per person year of new episodes of disease in the amoxicillin and placebo groups, respectively, were: MEE, 1.81 vs, 3.18 (P < 0.001); AOM, 0.28 vs, 1.0 4 (P < 0.001); and OME, 1.53 vs, 2.15 (P = 0.016), Subjects in the amo xicillin group had less time with MEE than the placebo group (19.7 and 33.2%, respectively; P = 0.002), Middle ear and throat cultures did n ot reveal any increase in beta-lactamase-producing organisms or in Str eptococcus pneumoniae attributable to daily use of amoxicillin. Conclu sions. Amoxicillin prophylaxis lowered the rates of occurrence of MEE, AOM and OME and decreased the percentage of time with MEE, However, b ecause of present day concerns regarding antibiotic resistance, manage ment should be individualized.