1. Reduction of fever and streptococcal bacteremia in granulocytopenic patients with cancer: a trial of oral penicillin V or placebo combined with pefloxacin
- Subjects
Granulocytopenia -- Drug therapy ,Cancer -- Physiological aspects ,Penicillin -- Evaluation ,Bacteremia -- Prevention - Abstract
Granulocytopenic cancer patients treated with pefloxacin and penicillin V may experience fewer fevers, infections, and episodes of streptococcal bacteria in the blood (bacteremia) than patients only treated with pefloxacin. Granulocytopenia is a decrease in a type of white blood cells called granulocytes. This condition impedes the body's ability to fight infection. Researchers studied 536 granulocytopenic patients who had leukemia, lymphoma, or solid tumors. All patients received 400 milligrams of pefloxacin orally every 12 hours. Half also were treated with 500 milligrams of oral penicillin V every 12 hours while the other half received an oral placebo every 12 hours. Twenty-nine percent of patients who received pefloxacin and penicillin and 20% of patients who received pefloxacin and a placebo did not develop fever or infection. Bacteria occurred in the blood of 14% of penicillin patients and 22% of placebo patients. Streptococcal organisms accounted for 5% of bacteremia cases in penicillin-treated patients and 10% of those in placebo recipients., 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, -1 6% 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, -1 4% 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 (1 0%) (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) more...
- Published
- 1994