title: Cefpodoxime proxetil suspension compared with cefaclor suspension for treatment of acute otitis media in paediatric patients.
abstract: 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 pyogenes: (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 ther 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, cefpodaxime 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.
authors.affiliation: PAIDEIA, Centro de Pediatria, Buenos Aires, Argentina.
authors.forename: G J
authors.initials: GJ
authors.lastname: MacLoughlin
authors.forename: D G
authors.initials: DG
authors.lastname: Barreto
authors.forename: C
authors.initials: C
authors.lastname: de la Torre
authors.forename: E A
authors.initials: EA
authors.lastname: Pinetta
authors.forename: F
authors.initials: F
authors.lastname: del Castillo
authors.forename: L
authors.initials: L
authors.lastname: Palma
mesh_terms: D000208:Acute Disease; D002433:Cefaclor / Q000009:adverse effects / Q000627:therapeutic use*; D015296:Ceftizoxime / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006192:Haemophilus Infections / Q000188:drug therapy; D006193:Haemophilus influenzae; D006801:Humans; D007223:Infant; D008297:Male; D001936:Moraxella catarrhalis; D016870:Neisseriaceae Infections / Q000188:drug therapy; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology; D011355:Prodrugs / Q000009:adverse effects / Q000627:therapeutic use*; D013203:Staphylococcal Infections / Q000188:drug therapy; D013211:Staphylococcus aureus; D013290:Streptococcal Infections / Q000188:drug therapy; D013296:Streptococcus pneumoniae; D013297:Streptococcus pyogenes; D013535:Suspensions; D000097627:Cefpodoxime Proxetil
chemical_list: D002433:Cefaclor; D015296:Ceftizoxime; D002511:Cephalosporins; D011355:Prodrugs; D013535:Suspensions; D000097627:Cefpodoxime Proxetil