Journal of Antimicrobial Chemotherapy (1996) 37, 565-573
© 1996 The British Society for Antimicrobial Chemotherapy
research-article |
Cefpodoxime proxetil suspension compared with cefaclor suspension for treatment of acute otitis media in paediatric patients
aPAIDEIA, Centro de Pediatria Cerviño 3900 3° piso, Buenos Aires, Argentina bHospital Infantil de México, "Federico Gomez" Mexico cHospital "Nuestra Señora del Pilar" Guatemala dPaediatric Department, Hospital La Paz Madrid, Spain eDepartment of ORL, Hospital Pereyra Rossel Montevideo, Uruguay
Received 1 March 1995; returned 6 September 1995; accepted 12 October 1995
*Tel: +54 1 802 2726: Fax: +54 1 807 0642
A multicentre open-label, randomised trial was performed to compare the efficacy and safety of cefpodoxime proxetil bd and cefaclor tds in the treatment of acute otitis media in children. A total of 167 children aged from 1 month to 11 years were enrolled in five centres: 78 treated with cefpodoxime and 83 treated with cefaclor, were evaluated in the ITT analysis. After tympanocentesis and culture of middle ear fluid, a pathogen was isolated from 85 (53%) of the 161 evaluable patients for the ITT analysis. The organisms isolated were as follows: Streptococcus pneumoniae: (n = 33, 37.5%); Haemophilus influenzae: (n = 22, 25%); Staphylococcus aureus: (n = 15, 17.1%); Streptococcus pvogenes: (n = 8, 9.1%); Moraxella catarrhalis: (n = 2, 2.3%); others (n = 6, 6.8%).
Success (defined as a satisfactory clinical outcome, either cure or improvement) was achieved at the end of treatment, in 93.6% of the patients in the cefpodoxime group and 91.6% of the patients in the cefaclor group (P > 0.05).
Clinical recurrence was identified at the follow-up visit (30 days after inclusion), in 6.4% of the cefpodoxime-treated patients and 7.2% of the cefaclor-treated patients (P > 0.05).
The drugs were well tolerated by 78/79 (99%) of patients in the cefpodoxime-treated group and 80/85 (94%) in the cefaclor-treated group. The incidence of adverse effects was higher in the cefaclor group than in the cefpodoxime group, but this was not statistically significant (P > 0.05).
In conclusion, cefpodoxime proxetil administered bd is as effective as cefaclor administered tds in the treatment of acute otitis media in children. The less frequent dosing schedule of cefpodoxime (bd) compared with cefaclor (tds) appears to be more convenient for the treatment of the infections in children.
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