JAC Advance Access originally published online on February 27, 2007
Journal of Antimicrobial Chemotherapy 2007 59(4):711-717; doi:10.1093/jac/dkm003
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Tobramycin once versus three times daily, given with penicillin G, to febrile neutropenic cancer patients in Norway: a prospective, randomized, multicentre trial
1 Cancer Clinic, Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway 2 Laboratory Clinic, Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway 3 Norwegian Institute of Public Health, Oslo, Norway 4 Department of Hematology, Ullevaal University Hospital, Oslo, Norway 5 Department of Internal Medicine, Buskerud Hospital Trust, Drammen, Norway 6 Department of Hematology and Oncology, Stavanger University Hospital, Stavanger, Norway 7 Department of Internal Medicine, Sørlandet Hospital Trust, Kristiansand, Norway 8 Department of Internal Medicine, Innlandet Hospital Trust, Gjøvik, Norway 9 The Norwegian Cancer Society, Oslo, Norway
Received 10 September 2006; returned 15 October 2006; revised 9 January 2007; accepted 10 January 2007
* Corresponding author. Tel: +47-22-93-51-36; Fax: +47-22-73-07-25; E-mail: dag.torfoss{at}radiumhospitalet.no
Objectives: Penicillin G with an aminoglycoside is the standard initial empirical treatment in febrile neutropenia in Norway. It has been argued that giving the aminoglycoside once daily to neutropenic patients with Gram-negative bacteraemia may be hazardous when penicillin G is the ß-lactam antibiotic. We questioned this argument and hypothesized that tobramycin once daily was as efficacious as three times daily.
Methods: We conducted a randomized prospective multicentre study, comparing the efficacy of tobramycin 6 mg/kg once (arm A) versus three times (arm B) daily, plus penicillin G 5 million IU x 4, in febrile neutropenic cancer patients. Primary outcome: modification of the antibiotic regimen.
Results: One hundred and seventy-four patients were evaluable for intention-to-treat analyses. One hundred and fifty-five patients had lymphoma or leukaemia as the underlying cancer diagnosis. In arm A, 35 of 88 patients and in arm B, 34 of 86 patients, that is 40% in both arms had no modification of the antibiotic regimen. No patients died while participating in the study. Upon modification of the antibiotic regimen, all patients were successfully treated. The increase in serum creatinine was modest and similar in the two treatment groups.
Conclusions: When administered with penicillin G, tobramycin given once daily was as efficacious and safe as tobramycin given three times daily in cancer patients with febrile neutropenia in Norway, provided the regimen was modified according to the clinical response.
Keywords: neutropenia , fever , antibiotics
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