Amphotericin B lipid complex in pediatric patients with invasive fungal infections

Thomas J. Walsh, Nita L. Seibel, Carola A.S. Arndt, Richard E. Harris, Mark J. Dinubile, Annette Reboli, John Hiemenz, Stephen J. Chanock

Research output: Contribution to journalArticle

114 Citations (Scopus)

Abstract

Background. Lipid formulations of amphotericin B have been recently introduced for treatment of invasive fungal infections. However, little is known about their role in pediatric populations. Methods. We studied the safety and antifungal efficacy of amphotericin B lipid complex (ABLC, Abelcet) in 111 treatment episodes in pediatric patients through an open label, emergency use multicenter study. Patients with invasive fungal infections were enrolled if they had mycoses refractory to conventional antifungal therapy, if they were intolerant of previous systemic antifungal agents or concomitant nephrotoxic drugs or if they had preexisting renal disease. Results. All 111 treatment episodes were evaluable for safety and 54 were evaluable for efficacy. The mean serum creatinine for the study population did not significantly change between baseline (1.23 ± 0.11 mg/dl) and cessation of ABLC therapy (1.32 ± 0.12 mg/dl) during 6 weeks. There were no significant differences observed between initial and end-of-therapy levels of serum potassium, magnesium, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and hemoglobin. However, there was an increase in mean total bilirubin (3.66 ± 0.73 to 5.31 ± 1.09 mg/dl) at the end of therapy (P = 0.054). Among 54 cases fulfilling criteria for evaluation of antifungal efficacy, a complete or partial therapeutic response was obtained in 38 patients (70%) after ABLC therapy. Complete or partial therapeutic response was documented in 56% of cases with aspergillosis (n = 25) and in 81% (n = 27) with candidiasis. Among premature infants (n = 8) and allogeneic marrow recipients (n = 14), response rates were 88 and 57%, respectively. Response was similar in those patients enrolled because of intolerance to previous antifungal therapy or because of progressive infection. Conclusions. These data support the use of ABLC for treatment of invasive fungal infections in pediatric patients who are intolerant of or refractory to conventional antifungal therapy.

Original languageEnglish (US)
Pages (from-to)702-708
Number of pages7
JournalPediatric Infectious Disease Journal
Volume18
Issue number8
DOIs
StatePublished - Aug 1999

Fingerprint

Pediatrics
Therapeutics
liposomal amphotericin B
Invasive Fungal Infections
Potassium Magnesium Aspartate
Safety
Preexisting Condition Coverage
Aspergillosis
Mycoses
Candidiasis
Antifungal Agents
Amphotericin B
Aspartate Aminotransferases
Serum
Alanine Transaminase
Bilirubin
Premature Infants
Population
Multicenter Studies
Alkaline Phosphatase

Keywords

  • Amphotericin B
  • Amphotericin B lipid complex
  • Aspergillosis
  • Candidiasis
  • Fusariosis
  • Zygomycosis

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)

Cite this

Amphotericin B lipid complex in pediatric patients with invasive fungal infections. / Walsh, Thomas J.; Seibel, Nita L.; Arndt, Carola A.S.; Harris, Richard E.; Dinubile, Mark J.; Reboli, Annette; Hiemenz, John; Chanock, Stephen J.

In: Pediatric Infectious Disease Journal, Vol. 18, No. 8, 08.1999, p. 702-708.

Research output: Contribution to journalArticle

Walsh, TJ, Seibel, NL, Arndt, CAS, Harris, RE, Dinubile, MJ, Reboli, A, Hiemenz, J & Chanock, SJ 1999, 'Amphotericin B lipid complex in pediatric patients with invasive fungal infections', Pediatric Infectious Disease Journal, vol. 18, no. 8, pp. 702-708. https://doi.org/10.1097/00006454-199908000-00010
Walsh, Thomas J. ; Seibel, Nita L. ; Arndt, Carola A.S. ; Harris, Richard E. ; Dinubile, Mark J. ; Reboli, Annette ; Hiemenz, John ; Chanock, Stephen J. / Amphotericin B lipid complex in pediatric patients with invasive fungal infections. In: Pediatric Infectious Disease Journal. 1999 ; Vol. 18, No. 8. pp. 702-708.
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abstract = "Background. Lipid formulations of amphotericin B have been recently introduced for treatment of invasive fungal infections. However, little is known about their role in pediatric populations. Methods. We studied the safety and antifungal efficacy of amphotericin B lipid complex (ABLC, Abelcet) in 111 treatment episodes in pediatric patients through an open label, emergency use multicenter study. Patients with invasive fungal infections were enrolled if they had mycoses refractory to conventional antifungal therapy, if they were intolerant of previous systemic antifungal agents or concomitant nephrotoxic drugs or if they had preexisting renal disease. Results. All 111 treatment episodes were evaluable for safety and 54 were evaluable for efficacy. The mean serum creatinine for the study population did not significantly change between baseline (1.23 ± 0.11 mg/dl) and cessation of ABLC therapy (1.32 ± 0.12 mg/dl) during 6 weeks. There were no significant differences observed between initial and end-of-therapy levels of serum potassium, magnesium, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and hemoglobin. However, there was an increase in mean total bilirubin (3.66 ± 0.73 to 5.31 ± 1.09 mg/dl) at the end of therapy (P = 0.054). Among 54 cases fulfilling criteria for evaluation of antifungal efficacy, a complete or partial therapeutic response was obtained in 38 patients (70{\%}) after ABLC therapy. Complete or partial therapeutic response was documented in 56{\%} of cases with aspergillosis (n = 25) and in 81{\%} (n = 27) with candidiasis. Among premature infants (n = 8) and allogeneic marrow recipients (n = 14), response rates were 88 and 57{\%}, respectively. Response was similar in those patients enrolled because of intolerance to previous antifungal therapy or because of progressive infection. Conclusions. These data support the use of ABLC for treatment of invasive fungal infections in pediatric patients who are intolerant of or refractory to conventional antifungal therapy.",
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