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October 19, 1994

Reduction of Fever and Streptococcal Bacteremia in Granulocytopenic Patients With CancerA Trial of Oral Penicillin V or Placebo Combined With Pefloxacin

Author Affiliations

the European Organization for Research and Treatment of Cancer
From the International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer, Brussels, Belgium.

JAMA. 1994;272(15):1183-1189. doi:10.1001/jama.1994.03520150051036

Objective.  —To determine the effect of oral penicillin V combined with a fluoroquinolone (pefloxacin) on the occurrence of fever and streptococcal and other gram-positive coccal bacteremic infections in granulocytopenic patients with cancer.

Design.  —Prospective randomized double-blinded placebo-controlled prophylactic trial.

Setting.  —Inpatient setting in multiple cooperating cancer centers.

Subjects.  —Convenience sample with a total of 551 granulocytopenic patients, 95% of whom had leukemia or underwent bone marrow transplantation.

Interventions.  —Penicillin V (500 mg twice a day) vs placebo given in combination with oral pefloxacin (400 mg twice a day).

Main Outcome Measures.  —Occurrence of fever and/or infection.

Results.  —Fever or infection (without fever) developed in 190 (71%) of 268 evaluable patients in the penicillin arm compared with 213 (80%) of 268 evaluable patients in the placebo arm (P=.03; 95% confidence interval [CI] for the difference, -16% to -1%). Bacteremia occurred in 58 (22%) of 268 placebo-treated patients and in 38 (14%) of 268 penicillin-treated patients (P=.03; 95% CI for the difference, -14% to -1%), primarily due to a reduction in streptococcal bacteremic episodes that occurred in 14 penicillin-treated patients (5%) and in 27 placebo-treated patients (10%) (P=.05; 95% CI for the difference, -9% to -0.3%). Gram-negative rod bacteremias occurred in only two patients (1%) and in five patients (2%), respectively. Logistic regression analysis also supported the treatment effect on the development of bacteremia.

Conclusions.  —These results demonstrate that the addition of penicillin V to fluoroquinolone prophylaxis in granulocytopenic patients with cancer effectively reduces febrile episodes and the incidence of bacteremia, especially that due to streptococcal species.(JAMA. 1994;272:1183-1189)