Amphotericin B colloidal dispersion (Amphocil) vs fluconazole for the prevention of fungal infections in neutropenic patients: data of a prematurely ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2000-04-01

AUTHORS

GJ Timmers, S Zweegman, AM Simoons-Smit, AC van Loenen, D Touw, PC Huijgens

ABSTRACT

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°C in 4/16 patients and of ⩾1°C but <2°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. Bone Marrow Transplantation(2000) 25 , 879–884. More... »

PAGES

879-884

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/sj.bmt.1702243

DOI

http://dx.doi.org/10.1038/sj.bmt.1702243

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1009839299

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/10808210


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