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Comparative trial of cefprozil vs. amoxicillin clavulanate potassium in the treatment of children with acute otitis media with effusion.
Pediatr Infect Dis J 1991; 10(5):375-80PI

Abstract

A total of 137 children with acute otitis media with effusion were randomly allocated to treatment with cefprozil (30 mg/kg/day divided into two equal doses), an investigational cephalosporin or amoxicillin clavulanate potassium (40 mg/kg/day divided into three equal doses) for 10 days. The most common pathogens obtained from middle ear cavities by tympanocentesis were Streptococcus pneumoniae (33%), Haemophilus influenzae (19.6%) and Moraxella catarrhalis (8.3%). Patients were scheduled for follow-up visits at midtreatment, at end of therapy and at 30 days. Of the 137 children 122 were evaluable. Five of 60 patients (8.3%) treated with cefprozil and 14 of 62 patients (22.5%) treated with amoxicillin clavulanate potassium were considered therapeutic failures because of persistence of symptoms and/or isolation of the original pathogen or superinfection (P = 0.05). Rates of relapse, reinfection and persistent middle ear effusion as documented by tympanogram were comparable in both groups. When persistent middle ear effusion was analyzed by pneumatic otoscopy, 64 of 103 affected ears (62.1%) treated with cefprozil and 80 of 105 affected ears (76.1%) treated with amoxicillin clavulanate potassium were abnormal (P = 0.04). Loose stools were more common in children treated with amoxicillin clavulanate potassium than in children treated with cefprozil (P = 0.0004). Based on the efficacy results from this study, the lower gastrointestinal side effects and the convenience of twice-a-day dosing, we believe that cefprozil in a dosage of 30 mg/kg/day divided every 12 hours represents a potential alternative for the treatment of acute otitis media with effusion in children.

Authors+Show Affiliations

Department of Pediatrics, Memorial Miller Children's Hospital, University of California, Irvine.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

1906160

Citation

Arguedas, A G., et al. "Comparative Trial of Cefprozil Vs. Amoxicillin Clavulanate Potassium in the Treatment of Children With Acute Otitis Media With Effusion." The Pediatric Infectious Disease Journal, vol. 10, no. 5, 1991, pp. 375-80.
Arguedas AG, Zaleska M, Stutman HR, et al. Comparative trial of cefprozil vs. amoxicillin clavulanate potassium in the treatment of children with acute otitis media with effusion. Pediatr Infect Dis J. 1991;10(5):375-80.
Arguedas, A. G., Zaleska, M., Stutman, H. R., Blumer, J. L., & Hains, C. S. (1991). Comparative trial of cefprozil vs. amoxicillin clavulanate potassium in the treatment of children with acute otitis media with effusion. The Pediatric Infectious Disease Journal, 10(5), pp. 375-80.
Arguedas AG, et al. Comparative Trial of Cefprozil Vs. Amoxicillin Clavulanate Potassium in the Treatment of Children With Acute Otitis Media With Effusion. Pediatr Infect Dis J. 1991;10(5):375-80. PubMed PMID: 1906160.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative trial of cefprozil vs. amoxicillin clavulanate potassium in the treatment of children with acute otitis media with effusion. AU - Arguedas,A G, AU - Zaleska,M, AU - Stutman,H R, AU - Blumer,J L, AU - Hains,C S, PY - 1991/5/1/pubmed PY - 1991/5/1/medline PY - 1991/5/1/entrez SP - 375 EP - 80 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 10 IS - 5 N2 - A total of 137 children with acute otitis media with effusion were randomly allocated to treatment with cefprozil (30 mg/kg/day divided into two equal doses), an investigational cephalosporin or amoxicillin clavulanate potassium (40 mg/kg/day divided into three equal doses) for 10 days. The most common pathogens obtained from middle ear cavities by tympanocentesis were Streptococcus pneumoniae (33%), Haemophilus influenzae (19.6%) and Moraxella catarrhalis (8.3%). Patients were scheduled for follow-up visits at midtreatment, at end of therapy and at 30 days. Of the 137 children 122 were evaluable. Five of 60 patients (8.3%) treated with cefprozil and 14 of 62 patients (22.5%) treated with amoxicillin clavulanate potassium were considered therapeutic failures because of persistence of symptoms and/or isolation of the original pathogen or superinfection (P = 0.05). Rates of relapse, reinfection and persistent middle ear effusion as documented by tympanogram were comparable in both groups. When persistent middle ear effusion was analyzed by pneumatic otoscopy, 64 of 103 affected ears (62.1%) treated with cefprozil and 80 of 105 affected ears (76.1%) treated with amoxicillin clavulanate potassium were abnormal (P = 0.04). Loose stools were more common in children treated with amoxicillin clavulanate potassium than in children treated with cefprozil (P = 0.0004). Based on the efficacy results from this study, the lower gastrointestinal side effects and the convenience of twice-a-day dosing, we believe that cefprozil in a dosage of 30 mg/kg/day divided every 12 hours represents a potential alternative for the treatment of acute otitis media with effusion in children. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/1906160/Comparative_trial_of_cefprozil_vs__amoxicillin_clavulanate_potassium_in_the_treatment_of_children_with_acute_otitis_media_with_effusion_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=1906160.ui DB - PRIME DP - Unbound Medicine ER -