Monotherapy with meropenem versus combination therapy with ceftazidime plus amikacin as empiric therapy for fever in granulocytopenic patients with cancer. The International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto Infection Program

Details

Serval ID
serval:BIB_E76A665985CE
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Monotherapy with meropenem versus combination therapy with ceftazidime plus amikacin as empiric therapy for fever in granulocytopenic patients with cancer. The International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto Infection Program
Journal
Antimicrobial Agents and Chemotherapy
Author(s)
Cometta  A., Calandra  T., Gaya  H., Zinner  S. H., de Bock  R., Del Favero  A., Bucaneve  G., Crokaert  F., Kern  W. V., Klastersky  J., Langenaeken  I., Micozzi  A., Padmos  A., Paesmans  M., Viscoli  C., Glauser  M. P.
ISSN
0066-4804 (Print)
Publication state
Published
Issued date
05/1996
Volume
40
Number
5
Pages
1108-15
Notes
Clinical Trial
Comparative Study
Controlled Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't --- Old month value: May
Abstract
Combinations of beta-lactams plus aminoglycosides have been standard therapy for suspected infections in granulocytopenic cancer patients, especially those with profound long-lasting granulocytopenia. With the advent of new broad-spectrum bactericidal antibiotics such as extended-spectrum cephalosporins or carbapenems, the need to combine beta-lactams with aminoglycosides became more controversial. The objective of this prospective randomized multicenter study was to compare the efficacy, safety, and tolerance of meropenem monotherapy with those of the combination of ceftazidime plus amikacin for the empirical treatment of fever in granulocytopenic cancer patients. Of 1,034 randomized patients, 958 were assessable in the intent-to-treat analysis for response to antibacterial therapy, including 483 in the meropenem group and 475 in the ceftazidime-plus-amikacin group. The median durations of neutropenia were 16 and 17 days, respectively. A successful outcome was reported in 270 of 483 (56%) patients treated with monotherapy compared with 245 of 475 (52%) patients treated with the combination group (P = 0.20). The success rates in the monotherapy group and the combination group were similar by type of infection (single gram-negative bacteremia, single gram-positive bacteremia, clinically documented infection, and possible infection). The occurrence of further infections assessed in patients for whom the allocated regimen was not modified did not differ between the two groups (12% in both groups). Mortality due to the presenting infection or further infection was relatively low (8 patients treated with the monotherapy compared with 13 patients treated with the combination). A total of 1,027 patients were evaluable for adverse events; the proportion of those who developed adverse effects was similar between the two groups (29% in both groups), and only 19 (4%) patients in the monotherapy group and 31 (6%) in the combination group experienced an adverse event related or probably related to the study drug. Allergic reactions were the only reason for stopping the protocol antibiotic(s) (3 and 5 patients, respectively). This study confirms that monotherapy with meropenem is as effective as the combination of ceftazidime plus amikacin for the empiric treatment of fever in persistently granulocytopenic cancer patients, and both regimens were well tolerated.
Keywords
Adolescent Adult Aged Agranulocytosis/complications/*drug therapy Amikacin/adverse effects/blood Ceftazidime/adverse effects/blood Child Child, Preschool Drug Therapy, Combination/*therapeutic use Fever/complications/*drug therapy Humans Infant Middle Aged Neoplasms/drug therapy/mortality Prospective Studies Thienamycins/adverse effects/blood/*therapeutic use
Pubmed
Web of science
Create date
25/01/2008 13:31
Last modification date
20/08/2019 16:10
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