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 = 0.005) and, when developing neutropenic fever, they had a lower probability of response to first-line empirical antibiotics (P = 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.

• Authors: Evangelos Eleutherakis-Papaiakovou, Evangelos Kostis, Magda Migkou, Dimitrios Christoulas, Evangelos Terpos, Maria Gavriatopoulou, Maria Roussou, Evangelos Bournakis, Efstathios Kastritis, Eleni Efstathiou, Meletios A Dimopoulos, Christos A Papadimitriou
• Journal: American journal of hematology (Am J Hematol) Vol. 85 Issue 11 Pg. 863-7 (Nov 2010) ISSN: 1096-8652 [Electronic] United States
• PMID: 20882526 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: © 2010 Wiley-Liss, Inc.

Chemical References

• Anti-Bacterial Agents
• Ciprofloxacin
• Vancomycin

Topics

• Anti-Bacterial Agents (administration & dosage, therapeutic use)
• Antibiotic Prophylaxis (methods)
• Ciprofloxacin (administration & dosage)
• Fever (prevention & control)
• Graft Survival
• Hematologic Neoplasms (mortality, therapy)
• Hematopoietic Stem Cell Transplantation (methods)
• Humans
• Infections
• Length of Stay
• Neutropenia (pathology, prevention & control)
• Survival Rate
• Transplantation, Autologous
• Vancomycin (administration & dosage)