title: Clinical efficacy and safety of cefetamet pivoxil in toddlers.
abstract: The safety and efficacy of cefetamet pivoxil, an oral cephalosporin of the third generation, have been studied in open, prospective, randomized comparative, clinical trials including 301 toddlers (children aged 1 to 2 years) with upper and lower respiratory tract infections, and urinary tract infections. Cefetamet pivoxil (CAT) syrup formulation was given to 177 toddlers either in the standard dose of 10 mg/kg b.i.d. [n = 116] or 20 mg/kg b.i.d. [n = 61] and 124 toddlers have been treated with comparator drugs [cefaclor, n = 98; phenoxymethylpenicillin, n = 18; amoxicillin plus clavulanic acid; n = 8]. The treatment period was 7 days mainly, except for pharyngotonsillitis for which the treatment duration was 7 or 10 days. The assessment of treatment was based on clinical signs and symptoms primarily in infections of lower respiratory tract and acute otitis media, whereas in patients with pharyngotonsillitis and acute urinary tract infections the bacteriological findings were the main evaluation criteria. The overall therapeutic outcome was successful in 148 (95.4%) of the 155 toddlers to whom CAT was administered and in 87 (85.3%) out of 102 toddlers receiving standard drugs. Adverse events of mild to moderate severity, mainly of gastro-intestinal type (vomiting or diarrhoea) occurred in 14.7% in the patient group receiving CAT, 11.2% in the toddlers receiving the standard dose of CAT, and in 12.9% with the comparator drugs. From the data presented it is concluded that cefetamet pivoxil is efficient and safe in toddlers presenting with community-acquired respiratory and urinary infections mainly caused by S. pneumoniae, H. influenzae, Group A beta-haemolytic streptococci, M. catarrhalis, E. coli, Proteus spp. and K. pneumoniae.
authors.affiliation: Hospital Gaffree e Guinle, Rio de Janeiro, Brazil.
authors.forename: A
authors.initials: A
authors.lastname: Chibante
authors.forename: E
authors.initials: E
authors.lastname: Peixoto
authors.forename: R
authors.initials: R
authors.lastname: Lejeune
authors.forename: K
authors.initials: K
authors.lastname: Winter
authors.forename: M
authors.initials: M
authors.lastname: Kissling