Prospective Randomized Comparative Observations of Infectious Complications with or without Antimicrobial Prophylaxis, during Autologous Stem Cell Transplantation

Abstract

Background: A prospective randomized comparative observation was performed to assess the benefit of prophylactic antimicrobials in autologous stem cell transplantation (ASCT). Methods: Forty consecutive patients, with multiple myelomas (MM, 28 patients) or a non-Hodgkin’s lymphoma (NHL, 12 patients), were stratified by disease and randomly allocated to receive (prophylaxis group, 21 patients) or not receive (control group, 19 patients) prophylactic antimicrobials. The prophylactic antimicrobials consisted of ciprofloxacin (500mg twice daily p.o.), fluconazole (100mg twice daily p.o.) and acyclovir (400mg every 8 h p.o.), starting 1 day before high-dose chemotherapy (high-dose melphalan for MM and BEAM for NHL), and continuing until neutrophil engraftment or the occurrence of infection. Results: At least one episode of fever occurred in 15 of the 19 (79%) patients in the control group, compared with 12 of the 21 (57%) in the prophylaxis group (P=NS). Microbiologically or clinically documented infections occurred in 4 patients (21%) in the control group, but none occurred in the prophylaxis group (P=NS). The documented infections in the control group included 3 staphylococcal bacteremias and 1 herpes skin infection. No deaths, invasive fungal infections or serious adverse events occurred in either group. The median duration of fever (9 days in the control group and 11 days in the prophylaxis group), therapeutic antimicrobial therapy (9 days in the control group and 11 days in the prophylaxis group) and hospital stay after ASCT (19 days in both groups) did not differ between the groups. Conclusion: This small-sized prospective randomized comparative observation showed no beneficial effects of antimicrobial prophylaxis in ASCT.