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Treatment of neonatal candidiasis with liposomal amphotericin B(L-AMP-LRC-1): phase II study

R N Kotwani1, P V Bodhe, B G Kirodian

  • 1Department of Clinical Pharmacology, Seth G.S. Medical College and K.E.M. Hospital, Parel, Mumbai 400 012, India.

Indian Pediatrics
|June 26, 2003
PubMed

Insights

A new liposomal amphotericin B (L-AMP-LRC-1) shows effectiveness in treating neonatal candidiasis. This low-cost drug offers a promising alternative for infant fungal infections.

Area of Science:

  • Mycology
  • Neonatal Medicine
  • Pharmacology

Background:

  • Neonatal candidiasis poses a significant health risk.
  • Existing treatments for invasive fungal infections in neonates can be costly and toxic.
  • Liposomal amphotericin B formulations offer improved safety profiles.

Purpose of the Study:

  • To evaluate the efficacy and safety of a novel liposomal amphotericin B preparation (L-AMP-LRC-1) in neonates with candidiasis.
  • To compare the effectiveness of L-AMP-LRC-1 with existing treatments at a lower dosage.

Main Methods:

  • An open-label, phase II clinical study was conducted.
  • Twenty-three neonates diagnosed with candidiasis received L-AMP-LRC-1 at a dose of 1 mg/kg for 28 days.
  • Treatment outcomes were assessed in 14 assessable patients.

Main Results:

  • All 14 assessable neonates achieved a complete clinical response to L-AMP-LRC-1 therapy.
  • L-AMP-LRC-1 demonstrated efficacy at a lower dose compared to AmBisome, another liposomal amphotericin B formulation.
  • The preparation was well-tolerated in the study population.

Conclusions:

  • Liposomal amphotericin B preparation (L-AMP-LRC-1) is an effective treatment for neonatal candidiasis.
  • L-AMP-LRC-1 presents a potentially cost-effective therapeutic option for treating fungal infections in newborns.
  • Further research into L-AMP-LRC-1 for neonatal fungal infections is warranted.

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