RESUMO
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.
RESUMO
We studied the efficacy and safety of cefetamet pivoxil (CAT), an oral aminothiazolyl cephalosporin, in a series of open, comparative multicenter studies in 207 women (four study centers) with uncomplicated gonorrhea, and summarized and pooled the results with those of earlier open dose-finding trials (360 men; six study centers). We compared single-dose treatment regimen of CAT--over the range of 400-1500 mg--with spectinomycin, thiamphenicol, ampicillin, or amoxicillin plus probenecid. The overall cure rates were 100% in 88 women treated with 1500 mg CAT and in 137 men treated with 1200 or 1500 mg CAT, 98% (114 of 116 men) in those treated with 800 or 1000 mg CAT, and 93% (42 of 45 men) in those treated with 400 or 500 mg CAT; the composite cure rate of the comparators was 97%. The tolerability of CAT (n = 428) compared favorably (1.8% adverse events) with that of the standard drugs (n = 139) (4.3% adverse events). Single-dose treatment with 1500 mg CAT is effective and safe in adults with uncomplicated gonorrhea.
Assuntos
Ceftizoxima/análogos & derivados , Gonorreia/tratamento farmacológico , Adolescente , Adulto , Idoso , Ceftizoxima/efeitos adversos , Ceftizoxima/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
In this multicentre, open, randomized, parallel-group study, 270 children with acute otitis media aged between 1 and 15 years were randomized to receive either cefetamet pivoxil 10 mg/kg b.i.d. for 7 days (n = 134) or cefaclor 13.5 mg/kg t.i.d. for 7 days (n = 136). At the end of treatment, bacteriological cure occurred in 44/44 (100%) patients receiving cefetamet pivoxil and 24/28 (86%) patients receiving cefaclor. Clinical cure or improvement was experienced by 117/121 (97%) of patients receiving cefetamet pivoxil and 104/115 (90%) patients in the cefaclor group. Adverse side effects, mainly gastrointestinal disorders, occurred in 11% of patients in the cefetamet pivoxil group compared with 15% of patients in the cefaclor group. All adverse events were of mild or moderate severity and subsided rapidly after treatment. Premature treatment withdrawals occurred in 0.7% of patients who received cefetamet pivoxil and in 2.2% of those who received cefaclor.
Assuntos
Cefaclor/uso terapêutico , Ceftizoxima/análogos & derivados , Otite Média/tratamento farmacológico , Doença Aguda , Administração Oral , Adolescente , Cefaclor/administração & dosagem , Ceftizoxima/administração & dosagem , Ceftizoxima/uso terapêutico , Criança , Pré-Escolar , Tolerância a Medicamentos , Seguimentos , Infecções por Haemophilus/tratamento farmacológico , Haemophilus influenzae/efeitos dos fármacos , Humanos , Lactente , Otite Média/microbiologia , Infecções Pneumocócicas/tratamento farmacológico , Indução de Remissão , Infecções Estreptocócicas/tratamento farmacológico , Streptococcus pyogenes/efeitos dos fármacosRESUMO
Cefetamet pivoxil was investigated in an open, randomized comparative study involving a total of 37 children with acute pyelonephritis, whose ages ranged from 2 to 14 years. The patients received either 10 mg/kg (n = 18) or 20 mg/kg (n = 8) cefetamet pivoxil twice daily, or 30-50 mg/kg amoxycillin/clavulanic acid three times daily (n = 11) for a period of 7-10 days. Escherichia coli was the main causative agent isolated in 28 (75.7%) of the patients; other pathogens included Proteus mirabilis (three patients). Proteus species (one patient), Klebsiella pneumoniae (two patients), Pseudomonas diminuta (one patient) and mixed infections (three patients). No differences in the overall treatment outcome could be observed between the treatment regimens used and, at the end of treatment, all pathogens were eradicated with neither relapse, nor persistence of the isolated pathogen, nor reinfection occurring. The clinical signs and symptoms had subsided in all patients at treatment end and the tolerability of the trial drugs was found to be satisfactory with no premature treatment withdrawal required. It is concluded that cefetamet pivoxil in the standard twice-daily dose of 10 mg/kg was equally effective and as well tolerated as 20 mg/kg cefetamet pivoxil given twice daily or 30-50 mg/kg amoxycillin/clavulanic acid given three times daily.