E. Cordero et al., Cefepime versus cefotaxime for empirical treatment of bacterial pneumonia in HIV-infected patients: an open, randomized trial, J ANTIMICRO, 48(4), 2001, pp. 527-534
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.