Liposomal amphotericin (AmBisome) in the prophylaxis of fungal infections in neutropenic patients: a randomised, double-blind, placebo-controlled study.

2.50
Hdl Handle:
http://hdl.handle.net/10541/88015
Title:
Liposomal amphotericin (AmBisome) in the prophylaxis of fungal infections in neutropenic patients: a randomised, double-blind, placebo-controlled study.
Authors:
Kelsey, S M; Goldman, J M; McCann, S; Newland, A C; Scarffe, J Howard; Oppenheim, B A; Mufti, G J
Abstract:
Liposomal amphotericin (AmBisome) 2 mg/kg three times weekly was compared with placebo as prophylaxis against fungal infection in patients undergoing chemotherapy or bone marrow transplantation (BMT) for haematological malignancies. Prophylaxis began on day 1 of chemotherapy and continued until neutrophils regenerated or infection was suspected. Of 161 evaluable patients, 74 received AmBisome and 87 received placebo. Proven fungal infections developed in no patients on AmBisome and in three on placebo (3.4%) (P = NS). Suspected fungal infections requiring intervention with systemic antifungal therapy (usually amphotericin B) occurred in 31 patients on AmBisome (42%) and in 40 on placebo (46%) (P = NS). Suspected deep-seated infections developed in 21 (28.3%) and 31 (35.6%) patients, respectively (P = NS). Time to develop a suspected or proven deep-seated infection showed a trend in favour of AmBisome (P = 0.11). Fifty patients had fungal colonisation (48 with Candida spp, two with Aspergillus spp) of at least one body site during prophylaxis; 15 patients while receiving AmBisome (20%) and 35 while on placebo (40%) (P < 0.01). Time to colonisation was significantly delayed in the group receiving AmBisome (P < 0.05). Treatment-related toxicity was modest and no additional toxicity was observed in patients receiving AmBisome. AmBisome 2 mg/kg three times weekly is safe and reduces fungal colonisation in patients receiving intensive chemotherapy or BMT. However, despite encouraging trends, prophylactic AmBisome did not lead to a significant reduction in fungal infection or in requirement for systemic antifungal therapy.
Affiliation:
Department of Haematology, Royal London Hospital, UK.
Citation:
Liposomal amphotericin (AmBisome) in the prophylaxis of fungal infections in neutropenic patients: a randomised, double-blind, placebo-controlled study. 1999, 23 (2):163-8 Bone Marrow Transplant.
Journal:
Bone Marrow Transplantation
Issue Date:
Jan-1999
URI:
http://hdl.handle.net/10541/88015
DOI:
10.1038/sj.bmt.1701543
PubMed ID:
10197802
Type:
Article
Language:
en
ISSN:
0268-3369
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorKelsey, S Men
dc.contributor.authorGoldman, J Men
dc.contributor.authorMcCann, Sen
dc.contributor.authorNewland, A Cen
dc.contributor.authorScarffe, J Howarden
dc.contributor.authorOppenheim, B Aen
dc.contributor.authorMufti, G Jen
dc.date.accessioned2009-12-15T15:12:40Z-
dc.date.available2009-12-15T15:12:40Z-
dc.date.issued1999-01-
dc.identifier.citationLiposomal amphotericin (AmBisome) in the prophylaxis of fungal infections in neutropenic patients: a randomised, double-blind, placebo-controlled study. 1999, 23 (2):163-8 Bone Marrow Transplant.en
dc.identifier.issn0268-3369-
dc.identifier.pmid10197802-
dc.identifier.doi10.1038/sj.bmt.1701543-
dc.identifier.urihttp://hdl.handle.net/10541/88015-
dc.description.abstractLiposomal amphotericin (AmBisome) 2 mg/kg three times weekly was compared with placebo as prophylaxis against fungal infection in patients undergoing chemotherapy or bone marrow transplantation (BMT) for haematological malignancies. Prophylaxis began on day 1 of chemotherapy and continued until neutrophils regenerated or infection was suspected. Of 161 evaluable patients, 74 received AmBisome and 87 received placebo. Proven fungal infections developed in no patients on AmBisome and in three on placebo (3.4%) (P = NS). Suspected fungal infections requiring intervention with systemic antifungal therapy (usually amphotericin B) occurred in 31 patients on AmBisome (42%) and in 40 on placebo (46%) (P = NS). Suspected deep-seated infections developed in 21 (28.3%) and 31 (35.6%) patients, respectively (P = NS). Time to develop a suspected or proven deep-seated infection showed a trend in favour of AmBisome (P = 0.11). Fifty patients had fungal colonisation (48 with Candida spp, two with Aspergillus spp) of at least one body site during prophylaxis; 15 patients while receiving AmBisome (20%) and 35 while on placebo (40%) (P < 0.01). Time to colonisation was significantly delayed in the group receiving AmBisome (P < 0.05). Treatment-related toxicity was modest and no additional toxicity was observed in patients receiving AmBisome. AmBisome 2 mg/kg three times weekly is safe and reduces fungal colonisation in patients receiving intensive chemotherapy or BMT. However, despite encouraging trends, prophylactic AmBisome did not lead to a significant reduction in fungal infection or in requirement for systemic antifungal therapy.en
dc.language.isoenen
dc.subject.meshAdult-
dc.subject.meshAmphotericin B-
dc.subject.meshAntibiotics, Antifungal-
dc.subject.meshAntigens, Fungal-
dc.subject.meshAspergillus-
dc.subject.meshCandida-
dc.subject.meshDouble-Blind Method-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshLiposomes-
dc.subject.meshLung Diseases, Fungal-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshMycoses-
dc.subject.meshNeutropenia-
dc.subject.meshPlacebos-
dc.titleLiposomal amphotericin (AmBisome) in the prophylaxis of fungal infections in neutropenic patients: a randomised, double-blind, placebo-controlled study.en
dc.typeArticleen
dc.contributor.departmentDepartment of Haematology, Royal London Hospital, UK.en
dc.identifier.journalBone Marrow Transplantationen

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