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

S. Zinner, MD; T. Calandra, MD; F. Meunier, MD, PhD; H. Gaya, MB, ChB, FRCPath; C. Viscoli, MD; J. Klastersky, MD; M. P. Glauser, MD; John Langenaken; Marianne Paesmans
JAMA. 1994;272(15):1183-1189. doi:10.1001/jama.1994.03520150051036.
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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)


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