{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:29:29Z","timestamp":1787016569149,"version":"build-2736575974"},"reference-count":36,"publisher":"American Society for Microbiology","issue":"10","license":[{"start":{"date-parts":[[2003,10,1]],"date-time":"2003-10-01T00:00:00Z","timestamp":1064966400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2003,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Infants and young children, especially those in day care, are at risk for recurrent or persistent acute otitis media (AOM). There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients. In this double-blind, double-dummy multicenter clinical trial, we compared a novel, high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM. Three hundred four children were randomized; 300 received either high-dose azithromycin (20 mg\/kg of body weight once a day for 3 days) or high-dose amoxicillin-clavulanate (90 mg\/kg divided twice a day for 10 days). Tympanocentesis was performed at baseline; clinical response was assessed at day 12 to 16 and day 28 to 32. Two-thirds of patients were aged \u22642 years. A history of recurrent, persistent, or recurrent plus persistent AOM was noted in 67, 18, and 14% of patients, respectively. Pathogens were isolated from 163 of 296 intent-to-treat patients (55%). At day 12 to 16, clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients (86 versus 84%, respectively) and for children aged \u22642 years (85 versus 79%, respectively). At day 28 to 32, clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients (72 versus 61%, respectively;\n                    <jats:italic>P<\/jats:italic>\n                    = 0.047) and for those aged \u22642 years (68 versus 51%, respectively;\n                    <jats:italic>P<\/jats:italic>\n                    = 0.017). Per-pathogen clinical efficacy against\n                    <jats:italic>Streptococcus pneumoniae<\/jats:italic>\n                    and\n                    <jats:italic>Haemophilus influenzae<\/jats:italic>\n                    was comparable between the two regimens. The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42%, respectively (\n                    <jats:italic>P =<\/jats:italic>\n                    0.095). Corresponding compliance rates were 99 and 93%, respectively (\n                    <jats:italic>P<\/jats:italic>\n                    = 0.018). These data demonstrate the efficacy and safety of high-dose azithromycin for treating recurrent or persistent AOM.\n                  <\/jats:p>","DOI":"10.1128\/aac.47.10.3179-3186.2003","type":"journal-article","created":{"date-parts":[[2003,9,23]],"date-time":"2003-09-23T18:25:36Z","timestamp":1064341536000},"page":"3179-3186","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":33,"title":["High-Dose Azithromycin versus High-Dose Amoxicillin-Clavulanate for Treatment of Children with Recurrent or Persistent Acute Otitis Media"],"prefix":"10.1128","volume":"47","author":[{"given":"Antonio","family":"Arrieta","sequence":"first","affiliation":[{"name":"Children's Hospital of Orange County, Orange, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriano","family":"Arguedas","sequence":"additional","affiliation":[{"name":"Neeman-ICIC, San Jose, Costa Rica"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pilar","family":"Fernandez","sequence":"additional","affiliation":[{"name":"Hospital Clinico Universidad de Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stan L.","family":"Block","sequence":"additional","affiliation":[{"name":"Kentucky Pediatric Research, Bardstown, Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paz","family":"Emperanza","sequence":"additional","affiliation":[{"name":"Otomed-Servicio Otorrinolaringologia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio L.","family":"Vargas","sequence":"additional","affiliation":[{"name":"Grupo de Estudios Clinicos, Facultad de Medicina Universidad de Chile, Santiago, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William A.","family":"Erhardt","sequence":"additional","affiliation":[{"name":"Pfizer Inc., New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal J.","family":"de Caprariis","sequence":"additional","affiliation":[{"name":"Pfizer Inc., New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Constance D.","family":"Rothermel","sequence":"additional","affiliation":[{"name":"Pfizer Inc., New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","unstructured":"Arguedas A. C. Loaiza A. Perez A. Gutierrez M. L. Herrera and C. D. Rothermel. A pilot study of single-dose azithromycin versus 3-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children. Curr. Ther. Res. in press."},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/00006454-199609009-00003"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.46.7.2194-2199.2002"},{"key":"e_1_3_2_5_2","doi-asserted-by":"crossref","unstructured":"Block S. L. A. Arrieta M. Seibel S. McLinn S. Eppes and M. J. Murphy. Single-dose (30 mg\/kg) azithromycin compared with amoxicillin\/clavulanate for the treatment of uncomplicated acute otitis media. Curr. Ther. Res. in press.","DOI":"10.1016\/j.curtheres.2003.09.006"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0165-5876(01)00550-X"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1097\/00006454-200111000-00003"},{"key":"e_1_3_2_8_2","unstructured":"Center for Drug Evaluation and Research. 1998. Guidance for industry acute otitis media\u2014developing antimicrobial drugs for treatment. Center for Drug Evaluation and Research (CDER) Food and Drug Administration U.S. Department of Health and Human Services Rockville Md."},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1097\/00006454-200204000-00008"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1086\/516284"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1097\/00006454-199603000-00015"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1097\/00006454-200210000-00003"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1097\/00006454-200109000-00002"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/00006454-200002000-00002"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.6.1721-1729.2001"},{"key":"e_1_3_2_16_2","first-page":"1","volume":"18","year":"1999","unstructured":"Dowell, S. F., J. C. Butler, G. S. Giebink, M. R. Jacobs, D. Jernigan, D. M. Musher, A. Rakowsky, and B. Schwartz. 1999. 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