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Quinolone-Based Antibacterial Chemoprophylaxis in Neutropenic Patients: Effect of Augmented Gram-Positive Activity on Infectious Morbidity

Eric J. Bow, MD, MSc; Lionel A. Mandell, MD; Thomas J. Louie, MD; Ronald Feld, MD; Michael Palmer, MSc; Benny Zee, PhD; and Joseph Pater, MD, MSc, for the NCIC Clinical Trials Group*
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Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1996;125(3):183-190. doi:10.7326/0003-4819-125-3-199608010-00004
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Objective: To determine whether augmented quinolone-based antibacterial prophylaxis in neutropenic patients with cancer reduces infections caused by gram-positive cocci and preserves the protective effect against aerobic gram-negative bacilli.

Design: Open, randomized, controlled, multicenter clinical trial.

Setting: Centers participating in the National Cancer Institute of Canada Clinical Trials Group.

Patients: 111 eligible and evaluable patients hospitalized for severe neutropenia (neutrophil count less than 0.5 × 109/L lasting at least 14 days) who were receiving cytotoxic therapy for acute leukemia or bone marrow autografting.

Intervention: One of three oral antibacterial prophylactic regimens (norfloxacin, 400 mg every 12 hours; ofloxacin, 400 mg every 12 hours; or ofloxacin, 400 mg, plus rifampin, 300 mg every 12 hours) beginning with cytotoxic therapy.

Measurements: Incidence and cause of suspected or proven infection.

Results: Microbiologically documented overall infection rates for norfloxacin, ofloxacin, and ofloxacin plus rifampin were 47%, 24%, and 9%, respectively (P < 0.001). Corresponding rates were 24%, 13%, and 3%, respectively for staphylococcal bacteremia (P = 0.03) and, 21%, 3%, and 3%, respectively for streptococcal bacteremia (P < 0.01). The pattern of bacteremia suggested that rifampin played a role in suppressing staphylococcal infection. Both ofloxacin alone and ofloxacin plus rifampin had a clinically significant antistreptococcal effect. Aerobic gram-negative rods were cleared from rectal surveillance cultures in all patients after a median of 5.5 days and caused infection in only one patient (0.9%). The reductions in the number of microbiologically documented infections among ofloxacin recipients and ofloxacin plus rifampin recipients were offset by concomitant increases in the number of unexplained fevers (24% of norfloxacin recipients, 53% of ofloxacin recipients, and 49% of ofloxacin plus rifampin recipients; P = 0.02). No statistically significant difference was found among the treatment arms with respect to the overall incidence of febrile neutropenic episodes as defined for this trial (79% for the norfloxacin group, 82% for the ofloxacin group, and 77% for the ofloxacin plus rifampin group).

Conclusions: Quinolone-based antibacterial chemoprophylaxis protected patients from aerobic gram-negative bacillary infections. Augmentation of the gram-positive activity reduced the incidence of gram-positive infections but did not influence the overall incidence of febrile neutropenic episodes.

*For additional investigators, see the Appendix.


Grahic Jump Location
Figure 1. Infections were caused by staphylococci (first set of diagonally striped bars; 0.447, 0.237, and 0.029 infections in patients treated with norfloxacin, ofloxacin, and ofloxacin plus rifampin, respectively), streptococci (black bars; 0.237, 0.026, and 0.029 infections), other microbiologically documented infections (second set of diagonally striped bars, 0.448, 0.158, and 0.085 infections), and clinically documented infections and unexplained fevers (white bars; 0.315, 0.737, and 0.886 infections).
Mean number of infections in patients treated with norfloxacin, ofloxacin, or ofloxacin plus rifampin.
Grahic Jump Location
Grahic Jump Location
Figure 2. 01). Chart shows patients at risk for infection on given days by treatment group.
Kaplan-Meier product limit plot of the time to bacteremic infection (P < 0.
Grahic Jump Location




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