Cefepime versus cefotaxime for empirical treatment of bacterial pneumonia in HIV-infected patients: an open, randomized trial

An open, randomized, multicentre clinical trial was conducted to compare th e efficacy and safety of cefepime 2 g iv bd (2 g tds daily in cases of Pseu domonas aeruginosa pneumonia) with cefotaxime 2 g iv tds, in the empirical treatment of bacterial pneumonia in HIV-infected patients. The primary end- point was effectiveness after 3-5 days of treatment, taking success to be w hen the study drug was continued during this period of time. Clinical and b acteriological responses at end of treatment (EOT) were also evaluated. Ana lyses of the intention-to-treat population (n = 160) and the as-per-protoco l groups (n = 150) were carried out. Treatment groups were comparable with regard to sex, age, HIV status and degree of severity of pneumonia. The pri mary end-point for cefepime was considered successful for the intention-to- treat and as-per-protocol groups in 85.7% and 93.5% of cases, respectively, and for cefotaxime, in 77.6% and 80.8% of cases, respectively (P = 0.22 an d P = 0.02). In the as-per-protocol group, cefotaxime treatment was indepen dently related to failure at the primary end-point. A satisfactory clinical response in the intention-to-treat population was observed in 83.3% of cef epime and 82.9% of cefotaxime patients. Bacteriological cure was obtained i n 100% of evaluable cefepime and 93.4% of evaluable cefotaxime patients at EOT. Safety of the study drugs was comparable in both treatment groups. Cef epime 2 g iv bd was at least as effective and as well tolerated as cefotaxi me 2 g iv tds in the treatment of bacterial pneumonia in HIV-infected patie nts.