318 Infection 28 · 2000 · No. 5 © URBAN & VOGEL Brief Reports Cefminox versus Metronidazole plus Gentamicin in Intra-abdominal Infections: A Prospective Randomized Controlled Clinical Trial A.J. Torres, L. Díez Valladares, J.M. Jover, A. Sánchez -Pernaute, J. Frías, A.J. Carcas, P. Coronel, E. Ródenas, I. Pérez-Balcabao, R. Fernández-Roblas, M. Moreno, J.L. Balibrea Summary Background: The aim of this prospective study was to compare the safety and efficacy of a new cephamycin, cefminox 2 g/12 h, to those of the usual regimen combining metronidazole 500 mg/8 h and gentamicin 80 mg/8 h (M+G). Patients and Methods: 160 patients with clinically proven intra-abdominal infection were prospectively included in an open parallel randomized comparative multicenter trial. Antibiotics were started preoperatively and discontinued after clinical and laboratory evidence of resolution of the infection. Serum and peritoneal fluid levels and serum bactericidal activities were also studied. Results: 150 patients were clinically evaluable. There was one failure in the cefminox group and three in the M+G group (not significant, RR: 1.07, 95% CI: 1–1.15). No differences were found in the number of wound infections, length of stay or duration of antibiotic therapy. Adverse effects were reported in 11 cases, all of them mild to moderate. Escherichia coli and Bacteroides fragilis were the most frequently found microorganisms. Conclusion: Cefminox is as effective and as safe as M+G in the treatment of intra-abdominal infections. Key Words Cefminox · Intra-abdominal infections · Clinical trial Infection 2000; 28: 318–322 Introduction The efficacy of several antibiotic regimens in the treatment of intra-abdominal infections is well established [1–4]. The choice of one treatment or another is based principally on patient factors.The combined regimens of an anaerobicide with an aminoglycoside have been used and are effective for empirical treatment of these patients.The aminoglyco- sides show a series of toxic effects especially in elderly, renal failure and shock patients [5–7]. This is the current reason for the tendency to use treatment regimens based on an combinations with fewer toxic effects or a single antibiotic having a similar spectrum of activity to the previously men- tioned combination, but with fewer side effects. Cefminox, a new cephamycin antibiotic with potent bactericidal activity [8–11], is characterized by a second lithic target of binding which differs from that of the clas- sic penicillin binding proteins (PBPs). Its antimicrobial spectrum covers both important aerobic and anaerobic or- ganisms [12]. Cefminox has a half-life of 2.35 h, and achieves peak serum levels of 117 mg/l following adminis- tration of a 2 g dose [13]. It penetrates extensively into retroperitoneal pelvic exudate and large areas under the curve of bactericidal powers are obtained against reference strains [13, 14].Therefore, cefminox is an antibiotic with an- tibacterial activity, pharmacokinetic profile and in vivo ef- ficacy, which makes it a suitable candidate for the treatment of intra-abdominal infections [8, 15]. The purpose of this study was to compare the clinical and microbiological efficacy and the safety of cefminox with those of metronidazole and gentamicin (M+G) in the empirical treatment of intra-abdominal infections. Patients and Methods Study Design Two surgical departments participated in the study which was de- signed as an open parallel randomized prospective trial. 160 patients over 18 years of age with signs and symptoms of intra-abdominal in- fection were consecutively included in the trial. Both surgery and percutaneous drainage under radiological control were classified as A.J. Torres (corresponding author), L. Díez Valladares, A. Sánchez- Pernaute, J.L. Balibrea Dept. of Surgery II, Clínico San Carlos Hospital, Complutense University, C/ Martín Lagos, s/n, E-28040 Madrid, Spain; Phone: (+34/91) 3303-444, Fax: -3179, e-mail: AJTORRES@teleline.es J.M. Jover, M. Moreno Dept. of Surgery, Getafe University Hospital, Madrid, Spain J. Frías, A.J. Carcas Clinical Pharmacology Dept., La Paz University Hospital, Madrid, Spain P. Coronel, E. Ródenas R & D Dept.,Tedec-Meiji Farma, S.A., Madrid, Spain I. Pérez-Balcabao Microbiology Dept., Gómez Ulla Hospital, Madrid, Spain R. Fernández-Roblas Microbiology Dept., Fundación Jiménez Díaz Hospital, Madrid, Spain. Received: March 29, 1999 • Revision accepted: July 1, 2000