A PROSPECTIVE CROSSOVER RANDOMIZED TRIAL OF NOVOBIOCIN AND RIFAMPIN PROPHYLAXIS FOR THE PREVENTION OF INTRAVASCULAR CATHETER INFECTIONS IN CANCER-PATIENTS TREATED WITH INTERLEUKIN-2

BACKGROUND. The aim of this study was to determine the efficacy of nov obiocin and rifampin as oral antibiotic prophylaxis for the prevention of catheter-related infection in melanoma patients treated with inter leukin-2 (IL-2) plus interferon-alpha and chemotherapy (biochemotherap y). METHODS. Patients with advanced melanoma who were treated with bio chemotherapy at the University of Texas M. D. Anderson Cancer Center w ere randomized in a crossover study to receive either oral antibiotic prophylaxis consisting of novobiocin and rifampin or observation alone over a 35-day course period. Patients were subsequently ''crossed ove r'' to the opposite arm of the study for an additional 35-day period, with each serving as his or her own control. RESULTS. Twenty-six patie nts were enrolled. Nine patients (35%) failed to tolerate oral antibio tics because of severe nausea and vomiting; 17 patients (65%) were cro ssed over and considered evaluable. During the control patient courses , 71% of evaluable patients had infectious complications, 41% had a ca theter-associated bacteremia, and 53% had a local catheter infection. In contrast, of the patients treated with antibiotic prophylaxis, only 12% had an infectious complication (P = 0.001), 12% had a local cathe ter infection (P = 0.008), and 6% had catheter-associated bacteremias (P = 0.04). Thirty-six episodes of catheter infections occurred during the 17 control courses, whereas only 3 episodes occurred during antib iotic prophylaxis (P < 0.001). CONCLUSIONS. Although more than one-thi rd of patients receiving IL-2 treatment with biochemotherapy failed to tolerate novobiocin and rifampin, this oral antibiotic regimen was ef ficacious in preventing the infectious complications, especially those associated with vascular catheters, in this high risk patient populat ion. (C) 1998 American Cancer Society.