Clinical Studies| Volume 17, ISSUE 5, P838-851, September 1995

Download started.


Clinical comparison of cefuroxime axetil suspension and amoxicillin/clavulanate suspension in the treatment of pediatric patients with acute otitis media with effusion

      This paper is only available as a PDF. To read, Please Download here.


      Two independent, investigator-blinded, multicenter, randomized clinical trials, one of which included microbiologic evaluation of middle-ear fluid obtained by use of tympanocentesis, compared the efficacy and safety of two oral antibiotics, cefuroxime axetil suspension and amoxicillin/clavulanate suspension, in the treatment of children 3 months to 12 years old diagnosed with acute otitis media with effusion (AOME). Four hundred seventy-seven pediatric patients with signs and symptoms of AOME were enrolled at 20 centers and were randomly assigned to receive 10 days of treatment with either cefuroxime axetil suspension 30 mg/kg per day in two divided doses (n = 235) or amoxicillin/clavulanate suspension 40 mg/kg per day in three divided doses (n = 242). Patients were assesed for their response to treatment once during treatment (at 3 to 5 days) and twice after treatment (at 1 to 4 days and at 14 to 18 days). In the study that included tympanocentesis, bacteriologic assessments were based on middle-ear fluid cultures obtained pretreatment, and, when possible, posttreatment in patients with an unsatisfactory clinical outcome. Organisms were isolated from the pretreatment middle-ear fluid specimens of 120 (73%) of 164 patients undergoing tympanocentesis, with the primary pathogens being Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis (27%, 24%, and 6% of isolates, respectively). Forty-four percent of the H influenzae isolates and 94% of the M catarrhalis isolates that were tested for beta-lactamase production were positive. A satisfactory clinical outcome (cure or improvement) was obtained in 70% (121 of 173) and 74% (131 of 177) of clinically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.40). With respect to the eradication of bacterial pathogens, in the study that included tympanocentesis a satisfactory outcome (cure or presumed cure) was obtained in 84% (32 of 38) and 95% (36 of 38) of bacteriologically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.26). Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil (37% vs 16%; P < 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (34% vs 12%; P < 0.001), particularly diarrhea. Eight patients in the cefuroxime axetil group and 11 patients in the amoxicillin/clavulanate group withdrew from the studies because of drug-related adverse events. These results indicate that cefuroxime axetil suspension 15 mg/kg twice daily is as effective as amoxicillin/clavulanate suspension 13.3 mg/kg three times daily in the treatment of pediatric patients with AOME, but produces fewer gastrointestinal adverse events, particularly diarrhea.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Clinical Therapeutics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Chow AW
        • Hall CB
        • Klein JO
        • et al.
        General guidelines for the evaluation of new anti-infective drugs for the treatment of respiratory tract infections.
        Clin Infect Dis. 1992; 15 (Suppl 1): S62-S88
        • Teele DW
        • Klein JO
        • Rosner B
        • The Greater Boston Otitis Media Study Group
        Epidemiology of otitis media during the first seven years of life in children in greater Boston: A prospective, cohort study.
        J Infect Dis. 1989; 160: 83-94
        • Lisby-Sutch SM
        • Nemec-Dwyer MA
        • Deeter RG
        • Gaur SN
        Therapy of otitis media.
        Clin Pharm. 1990; 9: 15-34
        • Emmerson AM
        Cefuroxime axetil.
        J Antimicrob Chemother. 1988; 22: 101-104
        • Murray PR
        Antimicrobial activity of seven oral antibiotics against selected community- and hospital-acquired pathogens.
        Clin Ther. 1991; 13: 224-231
        • Murray PR
        • Jones RN
        • Allen SD
        • et al.
        Multilaboratory evaluation of the in vitro activity of 13 beta-lactam antibiotics against 1474 clinical isolates of aerobic and anaerobic bacteria.
        Diagn Microbial Infect Dis. 1993; 16: 191-203
        • Washington JA
        • Jones RN
        • Gerlach EH
        • et al.
        Multicenter comparison of in vitro activities of FK-037, cefepime, ceftriaxone, ceftazidime, and cefuroxime.
        Antimirob Agents Chemother. 1993; 37: 1696-1700
        • Jorgensen JH
        • Doern GV
        • Maher LA
        • et al.
        Antimicrobial resistance among respiratory isolates of Haemophilus influenzae, Moraxella cattarhalis, and Streptococcus pneumoniae in the United States.
        Antimicrob Agents Chemother. 1990; 34: 2075-2080
        • Todd PA
        • Benfield P
        Amoxicillin/clavulanic acid: An update of its antibacterial activity, pharmacokinetic properties and therapeutic use.
        Drugs. 1990; 39: 264-307
        • Contardi I
        Comparative open study of amoxicillin/clavulanic acid (AAC) vs cefuroxime axetil (CAE) in children.
        in: Selected Abstracts Presented at the 8th Mediterranean Congress of Chemotherapy, May 24–29, 1992. Glaxo, Athens, Greece. Greenford, UK1992: 220 (Abstract)
        • Pichichero M
        • Aronovitz GH
        • Gooch WM
        • et al.
        Comparison of cefuroxime axetil, cefaclor, and amoxicillin-clavulanate potassium suspensions in acute otitis media in infants and children.
        South Med J. 1990; 83: 1174-1177
        • McLinn SE
        • Moskal M
        • Goldfarb J
        • et al.
        Comparison of cefuroxime axetil and amoxicillin-clavulanate suspensions in treatment of acute otitis media with effusion in children.
        Antimicrob Agents Chemother. 1994; 38: 315-318
        • Roge J
        • Durand B
        • Pappo M
        Treatment of ENT infections with cefuroxime axetil—comparative study versus an amoxicillin/clavulanic acid combination in specialized general practice.
        J Fr Oto-Rhino-Laryngol. 1989; 38 (In French): 138-143
        • National Committee for Clinical Laboratory Standards
        Performance Standards for Antimicrobial Disk Susceptibility Tests. National Committee for Clinical Laboratory Standards, Villanova, Pa1983
        • National Committee for Clinical Laboratory Standards
        Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically. National Committee for Clinical Laboratory Standards, Villanova, Pa1988
        • Finn A
        • Straughn A
        • Meyer M
        • Chubb J
        Effect of dose and food on the bioavailability of cefuroxime axetil.
        Biopharm Drug Dispos. 1987; 8: 519-526
        • Haddad Jr, J
        • Isaacson G
        • Respler DS
        • et al.
        Concentration of cefuroxime in serum and middle-ear effusion after single dose treatment with cefuroxime axetil.
        Pediatr Infect Dis J. 1991; 10: 294-298
        • Doern GV
        • Tubert AT
        In vitro activity of BAY v 3522, a new oral cephalosporin tested against Haemophilus influenzae and Branhamella catarrhalis.
        Diagn Microbiol Infect Dis. 1990; 13: 349-352
        • Doern GV
        In vitro activity of ceftibuten against Haemophilus influenzae and Branhamella catarrhalis.
        Diagn Microbial Infect Dis. 1991; 14: 75-77
        • Aguedas AG
        • Arrieta AC
        • Stutman HR
        • et al.
        In vitro activity of cefprozil (BMY 28100) and loracarbef (LY 163892) against pathogens obtained from middle ear fluid.
        J Antimicrob Chemother. 1991; 27: 311-318
        • Knapp CC
        • Washington II, JA
        In vitro activities of LY163892, cefaclor, and cefuroxime.
        Antimicrob Agents Chemother. 1988; 32: 131-133
        • Scaglione F
        • Ferrara F
        • Cogo R
        • et al.
        Pharmacokinetics and tissue penetration of clavulanic acid and amoxicillin given in combination and in a single intake.
        Proceedings of the 6th Mediterranean Congress of Chemotherapy. 22271988; (Taormina, Italy, Abstract): 35
        • Hugonot R
        • Hugonot L
        • Pappo M
        • Chiche D
        Ambulatory treatment with cefuroxime-axetil patients aged sixty years and more with infectious bronchitis: A comparative study with amoxicillin/clavulanic acid.
        Pathol Biol. 1990; 38 (In French): 533-537
        • Camacho AE
        • Cobo R
        • Otto J
        • et al.
        Clinical comparison of cefuroxime axetil and amoxicillin/clavulanate in the treatment of patients with acute bacterial maxillary sinusitis.
        Am J Med. 1992; 93: 271-276
        • Harding SM
        • Williams PO
        • Ayrton J
        Pharmacology of cefuroxime as the 1-acetoxyethyl ester in volunteers.
        Antimicrob Agents Chemother. 1984; 25: 78-82
        • Williams PO
        • Harding SM
        The absolute bioavailability of oral cefuroxime axetil in male and female volunteers after fasting and after food.
        J Antimicrob Chemother. 1984; 13: 191-196