Prophylactic antibiotics for the prevention of neutropenic fever in patients undergoing autologous stem‐cell transplantation: Results of a single institution, randomized phase 2 trial

Abstract

One hundred and fifty-seven patients undergoing high-dose chemotherapy (HDT) and autologous stem-cell transplantation (ASCT) for hematopoietic malignancies and solid tumors were randomly assigned to receive (Group A) or not (Group B) prophylaxis with ciprofloxacin, orally, and vancomycin, intravenously. Prophylactic antibiotics were given from day 0 until resolution of neutropenia or the appearance of a febrile event. Furthermore, patients in both groups received once a day fluconazole, orally. The primary end-point of our study was the incidence of neutropenic febrile episodes attributed to infection. One hundred and twelve (71.3%) patients developed neutropenic fever, 50 (56.2%) in Group A and 62 (91.2%) in Group B (P < 0.001) with the majority (82%) of patients developing fever of unknown origin. Patients on prophylactic antibiotics had a significantly lower rate of bacteremias (5.6%) than did those randomized to no prophylaxis (29.4%) (P 5 0.005) and, when developing neutropenic fever, they had a lower probability of response to first-line empirical antibiotics (P 5 0.025). Prophylactic administration of ciprofloxacin and vancomycin reduced the incidence of neutropenic fever in patients receiving HDT with ASCT, however, without affecting the total interval of hospitalization, time to engraftment, or all-cause mortality. Therefore, our results do not support the use of antibiotic prophylaxis for patients undergoing HDT and ASCT. Am. J. Hematol. 85:863-867, 2010. V

Bortezomib with chemotherapy is highly active in advanced B-precursor acute lymphoblastic leukemia: Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) Study

“…11 We opted for a different approach, namely, starting prophylaxis with vancomycin and levofloxacin from day 8 of therapy. [12][13][14][15] On the basis of the fungal infections observed in the phase 1 7 and in 1 of the patients treated on the phase 2, voriconazole or posaconazole were used from day 1. We found no further bacterial or fungal morbidity or mortality in the last 6 patients.…”

European Myeloma Network Guidelines for the Management of Multiple Myeloma-related Complications

“…In a randomized, phase II study in 157 patients who underwent ASCT, the administration of ciprofloxacin and vancomycin reduced the incidence of neutropenic fever, without affecting, however, the total interval of hospitalization, time to engraftment, or all-cause mortality. 86 In another study, 212 myeloma patients who received initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin (500 mg twice daily), trimethoprim-sulfamethoxazole (DS twice daily) or observation. The incidence of severe bacterial infections was similar among the three groups: 12.5%, 6.8% and 5.9%, respectively (P=0.218).…”

Prevention and Treatment of Cancer-Related Infections

“…80 Patients were randomized to receive prophylaxis (with 500 mg oral ciprofloxacin twice daily and 1000 mg intravenous vancomycin once daily) or no prophylaxis; all patients received antifungal prophylaxis with fluconazole. Empirical therapy (comprising amikacin, ceftazidime, and full-dose vancomycin) was initiated when neutropenic fever developed.…”