JAMA · 1994
Reduction of fever and streptococcal bacteremia in granulocytopenic patients with cancer. A trial of oral penicillin V or placebo combined with pefloxacin. International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer.
Клиническое исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Аннотация
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.
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.
Предметные рубрики MeSH
Administration, OralAdolescentAdultAgedAgranulocytosisBacteremiaBone Marrow TransplantationDouble-Blind MethodDrug Therapy, CombinationFemaleFeverGram-Positive Bacterial InfectionsHumansLogistic ModelsMaleMiddle AgedMultivariate AnalysisNeoplasmsPefloxacinPenicillin VRegression AnalysisStreptococcal Infections