Document Detail

Amphotericin B colloidal dispersion (Amphocil) vs fluconazole for the prevention of fungal infections in neutropenic patients: data of a prematurely stopped clinical trial.
MedLine Citation:
PMID:  10808210     Owner:  NLM     Status:  MEDLINE    
We conducted an open label, randomised clinical trial to compare amphotericin B colloidal dispersion (ABCD, Amphocil) 2 mg/kg/day intravenously with fluconazole 200 mg/day orally, for the prevention of fungal disease in neutropenic patients with haematological malignancies. In the event of unresolved fever after 4 days of empirical antibacterial therapy, patients in both treatment groups were to receive ABCD, 4 mg/kg/day. However, the study had to be stopped in an early phase, due to severe side-effects of ABCD. A total of 24 patients were enrolled, 12 patients were randomly assigned to receive prophylactic ABCD, which was administered for a mean of 13.9 days. Fluconazole prophylaxis was given to 12 patients for a mean of 21.2 days. Therapeutic ABCD, 4 mg/kg, was initiated in four patients because of suspected fungal infection, all of whom had initially received fluconazole. A high rate of infusion-related toxicity of ABCD was observed. Chills occurred in 15/16 ABCD recipients (94%), accompanied by a temperature rise of >/=2 degrees C in 4/16 patients and of >/=1 degrees C but <2 degrees C in 10/16 patients. Other ABCD-related adverse events were hypotension (4/16), nausea with vomiting (5/16), tachycardia (7/16), headache (3/16) and dyspnoea (3/16). For premedication patients received: antihistamines (12/16), hydrocortisone (9/16) and/or morphine (6/16). ABCD was discontinued in 8/16 patients (50%) due to side-effects, which ultimately dictated early termination of the study. We conclude that ABCD is not suitable for antifungal prophylaxis in neutropenic patients due to severe infusion-related side-effects. Subject numbers were too low for conclusions on variables of antifungal efficacy.
G J Timmers; S Zweegman; A M Simoons-Smit; A C van Loenen; D Touw; P C Huijgens
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Bone marrow transplantation     Volume:  25     ISSN:  0268-3369     ISO Abbreviation:  Bone Marrow Transplant.     Publication Date:  2000 Apr 
Date Detail:
Created Date:  2000-06-21     Completed Date:  2000-06-21     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8702459     Medline TA:  Bone Marrow Transplant     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  879-84     Citation Subset:  IM    
Department of Haematology, University Hospital Vrije Universiteit, Amsterdam, The Netherlands.
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MeSH Terms
Amphotericin B / administration & dosage,  contraindications,  toxicity*
Bilirubin / blood
Consumer Product Safety
Fluconazole / administration & dosage*,  toxicity
Hematologic Neoplasms / complications*,  drug therapy
Hematopoietic Stem Cell Transplantation / adverse effects
Infusions, Intravenous / adverse effects
Middle Aged
Morphine / therapeutic use
Mycoses / drug therapy*,  etiology,  prevention & control*
Neutropenia / complications*,  drug therapy
Respiratory Tract Diseases / chemically induced
Time Factors
Transaminases / blood
Reg. No./Substance:
1397-89-3/Amphotericin B; 57-27-2/Morphine; 635-65-4/Bilirubin; 86386-73-4/Fluconazole; EC 2.6.1.-/Transaminases

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