title: Comparative evaluation of loracarbef and amoxicillin-clavulanate for acute otitis media.
abstract: One hundred five infants and children with acute otitis media were randomized to therapy with loracarbef, an experimental carbacephem antibiotic, or amoxicillin-clavulanate (Augmentin), an approved drug for this disease. Ninety-two were evaluable (46 in each group). Middle ear fluid samples obtained for culture before therapy grew Haemophilus spp. in 30% of cases, pneumococci in 29% of cases, and Moraxella catarrhalis in 15% of cases. beta-Lactamase-producing bacteria were found in 37% of patients. Clinical failure occurred in four loracarbef-treated patients and one amoxicillin-clavulanate-treated patient (P = 0.361). Recurrence of acute otitis media was more common in the 2 to 3 weeks after loracarbef treatment (eight patients) than it was after amoxicillin-clavulanate therapy (three patients), but not significantly so (P = 0.197). Thus, combined failure and recurrence occurred in 12 loracarbef-treated patients and four amoxicillin-clavulanate-treated patients (P = 0.052). Gastrointestinal side effects occurred in 13 loracarbef-treated and 21 amoxicillin-clavulanate-treated patients (P = 0.13). Diaper rash was more common with amoxicillin-clavulanate (22 patients) than with loracarbef (10 patients; P = 0.016). Satisfactory results were achieved with both antibiotics, and adverse effects, although common, were minor.
authors.affiliation: Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas 75235-9063.
authors.forename: V N
authors.initials: VN
authors.lastname: Gan
authors.forename: H
authors.initials: H
authors.lastname: Kusmiesz
authors.forename: S
authors.initials: S
authors.lastname: Shelton
authors.forename: J D
authors.initials: JD
authors.lastname: Nelson
mesh_terms: D000208:Acute Disease; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D001419:Bacteria / Q000187:drug effects; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D008826:Microbial Sensitivity Tests; D010033:Otitis Media / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D011897:Random Allocation; D012008:Recurrence
chemical_list: D002511:Cephalosporins; D002969:Clavulanic Acids; C054920:loracarbef; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin