2 DIFFERENT DOSAGES OF CEFOTAXIME IN THE TREATMENT OF SPONTANEOUS BACTERIAL PERITONITIS IN CIRRHOSIS - RESULTS OF A PROSPECTIVE, RANDOMIZED, MULTICENTER STUDY

Cefotaxime (CTX) is considered one of the first-choice antibiotics in the therapy of spontaneous bacterial peritonitis (SEP) in cirrhosis, B ecause CTX is largely metabolized in the liver, this drug may also be effective in SEP by administering lower doses than those habitually us ed. To investigate this possibility, a prospective, randomized, multic enter study was performed to compare the therapeutic efficacy of two d ifferent dosages of CTX in 143 patients with SBP: 71 (group I) were al located to receive a high dose (2 g every 6 hours, which is one of the most frequently recommended doses in this infection), and 72 (group I I) were allocated to receive a low dose (2 g every 12 hours), At inclu sion, both groups were similar in relation to clinical and laboratory data, with the exception of a higher incidence of positive ascitic flu id culture in group I than in group II (59% vs, 40%; P = .029), The ra te of infection resolution was similar for both groups (77% vs, 79%), Hospital survival was also similar in both groups (69% vs, 79%). No di fference was observed between patients with positive or negative ascit ic fluid cultures with regard to infection resolution and patient surv ival. The duration of antibiotic therapy was similar in both groups (9 .0 +/- 3.3 days in group I vs, 8.8 +/- 3.1 days in group II). In a sub set of 13 patients from group I and 11 patients from group II CTX leve ls were determined in serum (peak and trough) and ascitic fluid (conco mitantly with trough serum), Peak serum levels were similar in patient s from both groups, In contrast, trough serum and/or ascitic fluid lev els were significantly lower or more frequently undetectable in group II patients than in group I patients, Nevertheless, this feature did n ot correlate with infection resolution or patient survival These resul ts indicate that the high efficacy of CTX in SBP can be maintained by using doses lower than those habitually recommended.