TY - JOUR
T1 - Randomized comparative study of cefepime and cefotaxime in the treatment of acute obstetric and gynaecological infections
AU - Newton, E. R.
AU - Yeomans, E. R.
AU - Pastorek, J. G.
AU - Soper, D. E.
AU - Hemsell, D. L.
PY - 1993/11/1
Y1 - 1993/11/1
N2 - Patients with presumed acute gynaecological infections were randomized (2:1) to receive cefepime 2 g every 12 h (n = 159) or cefotaxime 2 g every 8 h (n = 72), both im or by a 30-min iv infusion. For evaluation of efficacy, patients were required to have a bacteriologically documented infection, with at least one pathogen isolated susceptible to both drugs. Duration of treatment was 2–8 days in the 95 cefepime-treated patients and 3–10 days in the 36 cefotaxime-treated patients with evaluable infections; approximately three-quarters of the patients in each group were treated for 4–5 days. Clinical response was satisfactory in 81/95 (85%) of the evaluable cefepime recipients and 30/36 (83%) of the evaluable cefotaxime recipients (P = 0-802). In total, 211 (85%) of the 247 pathogens isolated from evaluable cefepime recipients were eradicated, compared with 98 (90%) of 109 pathogens isolated from evaluable cefotaxime recipients. All pathogens were eradicated in 77 (81%) cefe-pime-treated patients and in 31 (86%) cefotaxime-treated patients (P = 0.379). Overall response to treatment, calculated by combining clinical response and individual patient bacteriological response, was considered effective, partially effective or ineffective in 77%, 13% and 11% of cefepime-treated patients respectively and in 75%, 19% and 6% of cefotaxime-treated patients respectively (P = 0.932 for effective response). Adverse clinical events were reported by 68 (43%) of 159 cefepime recipients and by 26 (36%) of 72 cefotaxime recipients (P = 0.342); adverse events were deemed drug-related in 6% of cefepime recipients (diarrhoea, rash and headache) and in 1% of cefotaxime recipients (diarrhoea, pruritus and rash). Treatment was discontinued prematurely due to adverse events in five cefepime-treated patients and in one cefotaxime-treated patient (P = 0.476). Local intolerance was reported by 33 (21%) of the 159 cefepime-treated patients and by 14 (19%) of the 72 cefotaxime-treated patients receiving drug via the iv route alone; none of the patients discontinued treatment because of local intolerance. Laboratory test abnormalities were observed in a small number of patients in each group (1–8%), but none warranted discontinuation of treatment. Cefepime 2 g bd appears to have efficacy and safety comparable to that of cefotaxime 2 g tid in the treatment of acute obstetric and gynaecological infections.
AB - Patients with presumed acute gynaecological infections were randomized (2:1) to receive cefepime 2 g every 12 h (n = 159) or cefotaxime 2 g every 8 h (n = 72), both im or by a 30-min iv infusion. For evaluation of efficacy, patients were required to have a bacteriologically documented infection, with at least one pathogen isolated susceptible to both drugs. Duration of treatment was 2–8 days in the 95 cefepime-treated patients and 3–10 days in the 36 cefotaxime-treated patients with evaluable infections; approximately three-quarters of the patients in each group were treated for 4–5 days. Clinical response was satisfactory in 81/95 (85%) of the evaluable cefepime recipients and 30/36 (83%) of the evaluable cefotaxime recipients (P = 0-802). In total, 211 (85%) of the 247 pathogens isolated from evaluable cefepime recipients were eradicated, compared with 98 (90%) of 109 pathogens isolated from evaluable cefotaxime recipients. All pathogens were eradicated in 77 (81%) cefe-pime-treated patients and in 31 (86%) cefotaxime-treated patients (P = 0.379). Overall response to treatment, calculated by combining clinical response and individual patient bacteriological response, was considered effective, partially effective or ineffective in 77%, 13% and 11% of cefepime-treated patients respectively and in 75%, 19% and 6% of cefotaxime-treated patients respectively (P = 0.932 for effective response). Adverse clinical events were reported by 68 (43%) of 159 cefepime recipients and by 26 (36%) of 72 cefotaxime recipients (P = 0.342); adverse events were deemed drug-related in 6% of cefepime recipients (diarrhoea, rash and headache) and in 1% of cefotaxime recipients (diarrhoea, pruritus and rash). Treatment was discontinued prematurely due to adverse events in five cefepime-treated patients and in one cefotaxime-treated patient (P = 0.476). Local intolerance was reported by 33 (21%) of the 159 cefepime-treated patients and by 14 (19%) of the 72 cefotaxime-treated patients receiving drug via the iv route alone; none of the patients discontinued treatment because of local intolerance. Laboratory test abnormalities were observed in a small number of patients in each group (1–8%), but none warranted discontinuation of treatment. Cefepime 2 g bd appears to have efficacy and safety comparable to that of cefotaxime 2 g tid in the treatment of acute obstetric and gynaecological infections.
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U2 - 10.1093/jac/32.suppl_B.195
DO - 10.1093/jac/32.suppl_B.195
M3 - Article
C2 - 8150763
AN - SCOPUS:0027764338
SN - 0305-7453
VL - 32
SP - 195
EP - 204
JO - Journal of Antimicrobial Chemotherapy
JF - Journal of Antimicrobial Chemotherapy
ER -