Randomized double-blind study of liposomal amphotericin B (Ambisome) prophylaxis of invasive fungal infections in bone marrow transplant recipients
Tollemar, J.; Ringdén, O.; Andersson, S.; Sundberg, B.; Ljungman, P.; Tydén, G.
Bone Marrow Transplantation 12(6): 577-582
1993
ISSN/ISBN: 0268-3369 PMID: 8136741 Document Number: 418188
A placebo controlled double-blind randomized prophylactic trial was conducted to determine the effectiveness of a liposomal formulation of amphotericin B (Ambisome) in preventing fungal infection in bone marrow transplant patients at the Huddinge Hospital, Sweden. Ambisome was administered when neutrophil count decreased to <0.5 x 109/litre and was continued until neutrophils recovered to this level or an infection or toxicity end-point was reached. 36 patients received Ambisome (1 mg/kg daily) and 40 patients received placebo daily. There were no statistical differences in characteristics or clinical course between the 2 groups. Candida colonization decreased in the Ambisome group and increased in the placebo group. By the end of prophylaxis, 8 of 24 patients (33%) receiving Ambisome had candidal colonization compared with 18 of 29 placebo patients (62%) (P=0.05). Five and 7 patients on Ambisome or placebo, respectively, were withdrawn due to a presumed fungal infection. There was no statistical reduction of autopsy-proven fungal infection. Proven fungal infection occurred in 1 patient receiving Ambisome (C. guilliermondii) compared with 3 patients receiving placebo (2 C. guilliermondii and 1 C. albicans). Ambisome was generally well tolerated; allergic reactions were observed in 3 patients.