Journal of Heparology 2000; 32: 59G602 Printed in Denmark Ail rights reserved Munksgaard . Copenhagen Copyright 6 European Association zyxwvutsr for the Study of the Liver 2000 Journal of Hepatology ISSN 0168-8278 Amoxicillin-clavulanic acid versus cefotaxime in the therapy of bacterial infkctions in cirrhotic patients Elena Ricart, Germ&n Soriano, Maria Teresa Novella, Jordi Ortiz, Miriam Sgbat, Lylian Kolle, Javier Sola-Vera, Josep Mifiana, Josep Maria Dedeu, Cristina Gomez, Jose L. Barrio’ and Carlos Guarner Departments of Gastroenterology, Liver Section, and ‘Internal Medicine, Infectious Diseases Unit, Hospital de la Santa Creu i Sant Pau, Universitat Autbnoma de Barcelona, Barcelona, Spain Background/Aim: Cefotaxime is considered the first- choice antibiotic for empirical treatment in cirrhotic patients developing bacterial infections. It has been suggested that amoxicillin-clavulanic acid could be an alternative to cefotaxime, particularly in patients de- veloping bacterial infections while on prophylactic norlloxacin. The aim of the present study was to com- pare amoxicilhn-clavulanic acid with cefotaxime in the treatment of bacterial infections in cirrhosis. Methods: Ninety-six hospitalized cirrhotic patients with suspicion of bacterial infection were prospec- tively included and randomized into two groups: one group (n=48) received amoxicillin-clavulanic acid, first intravenously 1 g-O.2 g every 8 h, and then orally 500 mg-125 mg every 8 h, and the other group (n= 48) received intravenous cefotaxime 1 g every 6 h. Patients were stratified for previous prophylaxis with norfloxacin and ascitic fluid infection. Results: Sixteen patients were excluded from the analysis because bacterial infection was not demon- strated or because of secondary peritonitis. Therefore, 38 patients from the amoxicillin-clavulanic acid group and 42 from the cefotaxime group were finally ana- zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHG B ACTERIAL infections, particularly spontaneous bac- terial peritonitis and bacteremia, are frequent and severe complications in cirrhotic patients (l-3). Since Felisart et al. demonstrated that cefotaxime is more effective than ampicillin-tobramycin in the treatment Received 4 May; revised 23 September: accepted 29 September 1999 Correspondence: Carlos Guarner, Department of Gastro- enterology, Liver Section, Hospital de la Santa Creu i Sant Pau, Universitat Autbnoma de Barcelona, Avda. Sant An- toni M” Claret 167, 08025 Barcelona, Spain. Tel: 34 3 291 91 39. Fax: 34 3 291 92 78. e-mail: cguarner@hsp.santpau.es lyzed. There were 24 ascitic fluid infections in each group Infection resolution (86.8% rs 88%, 95% CI: -0.15 to 0.13,~ NS), spontaneous bacterial peritonitis resolution (87.5% YS 83.3%, 95% CI: -0.15 to 0.24, p NS), duration of treatment, incidence of complications, time of hospitalization and hospital mortality were similar in both groups. Considering patients on prophy- lactic norfloxacin, infection resolution was also similar (100% vs 83.3%, 95% CI: -0.04 to 0.37, p NS). No adverse events were observed in either of the two groups, The cost of antibiotics was statistically lower in the amoxicillin-clavulanic acid group (p<O.OOl). Conckusions: Amoxicillin-clavulanic acid is as effec- tive as cefotaxime in the treatment of bacterial infec- tions in cirrhotic patients, but is less expensive and can be administered orally. These results suggest that amoxicillin-clavulanic acid is an effective alternative to cefotaxime for the empirical treatment of bacterial infections in cirrhosis. Key words: Amoxicillin-clavulanic acid; Bacterial in- fections; Cefotaxime; Cirrhosis; Spontaneous bac- terial peritonitis. of bacterial infections in cirrhotic patients (4), it has been considered the first-choice antibiotic for empirical treatment in such patients, achieving an infection resol- ution rate of 80-90% (4-7). However, several studies have evaluated the efficacy of other antibiotics in the treatment of bacterial infections in cirrhosis (8-12). Amoxicillin associated with the beta-lactamase inhibi- tor clavulanic acid shows activity against most bacteria (gram-negative bacilli as well as gram-positive cocci) responsible for the infections in cirrhotic patients (13). Moreover, it has been demonstrated that amoxicillin- clavulanic acid reaches therapeutic levels in serum and ascitic fluid after intravenous administration in cir- 596