title: A prospective crossover randomized trial of novobiocin and rifampin prophylaxis for the prevention of intravascular catheter infections in cancer patients treated with interleukin-2.
abstract: BACKGROUND
  The aim of this study was to determine the efficacy of novobiocin and rifampin as oral antibiotic prophylaxis for the prevention of catheter-related infection in melanoma patients treated with interleukin-2 (IL-2) plus interferon-alpha and chemotherapy (biochemotherapy).
  
  
  METHODS
  Patients with advanced melanoma who were treated with biochemotherapy at the University of Texas M. D. Anderson Cancer Center were 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 over" 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 patients were enrolled. Nine patients (35%) failed to tolerate oral antibiotics because of severe nausea and vomiting; 17 patients (65%) were crossed over and considered evaluable. During the control patient courses, 71% of evaluable patients had infectious complications, 41% had a catheter-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 catheter 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 antibiotic prophylaxis (P < 0.001).
  
  
  CONCLUSIONS
  Although more than one-third of patients receiving IL-2 treatment with biochemotherapy failed to tolerate novobiocin and rifampin, this oral antibiotic regimen was efficacious in preventing the infectious complications, especially those associated with vascular catheters, in this high risk patient population.
authors.affiliation: Department of Medical Specialties, the University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
authors.forename: I I
authors.initials: II
authors.lastname: Raad
authors.forename: R Y
authors.initials: RY
authors.lastname: Hachem
authors.forename: D
authors.initials: D
authors.lastname: Abi-Said
authors.forename: K V
authors.initials: KV
authors.lastname: Rolston
authors.forename: E
authors.initials: E
authors.lastname: Whimbey
authors.forename: A C
authors.initials: AC
authors.lastname: Buzaid
authors.forename: S
authors.initials: S
authors.lastname: Legha
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D016470:Bacteremia / Q000209:etiology / Q000517:prevention & control; D001424:Bacterial Infections / Q000517:prevention & control*; D002405:Catheterization, Central Venous / Q000009:adverse effects / Q000295:instrumentation; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation; D002408:Catheters, Indwelling / Q000009:adverse effects*; D018890:Chemoprevention; D018592:Cross-Over Studies; D004866:Equipment Contamination; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D007371:Interferon-gamma / Q000627:therapeutic use; D007376:Interleukin-2 / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000628:therapy*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009675:Novobiocin / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D012293:Rifampin / Q000008:administration & dosage / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000900:Anti-Bacterial Agents; D000970:Antineoplastic Agents; D007155:Immunologic Factors; D007376:Interleukin-2; D009675:Novobiocin; D007371:Interferon-gamma; D012293:Rifampin