title: 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.affiliation: Department of Clinical Therapeutics, University of Athens School of Medicine, Alexandra Hospital, Athens, Greece.
authors.forename: Evangelos
authors.initials: E
authors.lastname: Eleutherakis-Papaiakovou
authors.forename: Evangelos
authors.initials: E
authors.lastname: Kostis
authors.forename: Magda
authors.initials: M
authors.lastname: Migkou
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Christoulas
authors.forename: Evangelos
authors.initials: E
authors.lastname: Terpos
authors.forename: Maria
authors.initials: M
authors.lastname: Gavriatopoulou
authors.forename: Maria
authors.initials: M
authors.lastname: Roussou
authors.forename: Evangelos
authors.initials: E
authors.lastname: Bournakis
authors.forename: Efstathios
authors.initials: E
authors.lastname: Kastritis
authors.forename: Eleni
authors.initials: E
authors.lastname: Efstathiou
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: Christos A
authors.initials: CA
authors.lastname: Papadimitriou
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use; D019072:Antibiotic Prophylaxis / Q000379:methods*; D002939:Ciprofloxacin / Q000008:administration & dosage; D005334:Fever / Q000517:prevention & control; D006085:Graft Survival; D019337:Hematologic Neoplasms / Q000401:mortality / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D007239:Infections; D007902:Length of Stay; D009503:Neutropenia / Q000473:pathology / Q000517:prevention & control*; D015996:Survival Rate; D014182:Transplantation, Autologous; D014640:Vancomycin / Q000008:administration & dosage
chemical_list: D000900:Anti-Bacterial Agents; D002939:Ciprofloxacin; D014640:Vancomycin