Randomized comparative study of cefepime and cefotaxime in the treatment of acute obstetric and gynaecological infections.
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 i.v. 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%) cefepime-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.
Newton
E R
ER
Department of Obstetrics/Gynecology, University of Texas Health Center at San Antonio.
Yeomans
E R
ER
Pastorek
J G
JG
Soper
D E
DE
Hemsell
D L
DL
D000293:Adolescent; D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D000077723:Cefepime; D002439:Cefotaxime / Q000009:adverse effects / Q000627:therapeutic use*; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005831:Genital Diseases, Female / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D011645:Puerperal Infection / Q000188:drug therapy* / Q000382:microbiology
D002511:Cephalosporins; D000077723:Cefepime; D002439:Cefotaxime