A randomized, double-blind trial investigating the efficacy of caspofungin versus amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants younger than 3 months of age.

Abstract

OBJECTIVES:

Investigate the efficacy of caspofungin in participants <3 months of age with invasive Candida infection (ICI).

METHODS:

This multicentre, randomized, double-blind, comparator-controlled, Phase 2 study (protocol MK0991-064; NCT01945281) enrolled participants <3 months of age with culture-confirmed ICI within 96 h of study entry. Participants were randomly assigned 2:1 to once-daily intravenous 2 mg/kg caspofungin or intravenous 1 mg/kg amphotericin B deoxycholate (dAMB). The primary endpoint was fungal-free survival (FFS) 2 weeks after treatment in the full-analysis-set (FAS) population, defined as participants with culture-confirmed ICI who received ≥1 dose of therapy. Planned enrolment was 90 participants.

RESULTS:

Fifty-one participants were enrolled; 49 received treatment (caspofungin, n=33; dAMB, n=16); 2 additional participants did not have confirmed infections at study entry. The study was terminated after ∼ 3.5 years because of low enrolment. Forty-seven participants were included in the FAS population (caspofungin, n=31; dAMB, n=16). FFS rate at 2 weeks after treatment was 71.0% (22/31) in the caspofungin arm and 68.8% (11/16) in the dAMB arm [difference, stratified by weight, - 0.9% (95% CI, - 24.3%-27.7%)]. Adverse events developed in 84.8% (28/33) of participants in the caspofungin arm and 100% (16/16) in the dAMB arm.

CONCLUSIONS:

Among neonates and infants with confirmed ICI, FFS at 2 weeks was similar in the caspofungin and dAMB treatment arms. A smaller proportion of participants who received caspofungin experienced adverse events.

• Authors: Jason Kim, Firdose Lambey Nakwa, Fábio Araujo Motta, Hong Liu, Mary Beth Dorr, Leah J Anderson, Nicholas Kartsonis
• Journal: The Journal of antimicrobial chemotherapy (J Antimicrob Chemother) Vol. 75 Issue 1 Pg. 215-220 (01 01 2020) ISSN: 1460-2091 [Electronic] England
• PMID: 31586424 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: [email protected].

Chemical References

• Antifungal Agents
• Drug Combinations
• Deoxycholic Acid
• Amphotericin B
• amphotericin B, deoxycholate drug combination
• Caspofungin

Topics

• Amphotericin B (therapeutic use)
• Antifungal Agents (therapeutic use)
• Candidiasis, Invasive (drug therapy)
• Caspofungin (therapeutic use)
• Deoxycholic Acid (therapeutic use)
• Double-Blind Method
• Drug Combinations
• Female
• Humans
• Infant
• Infant, Newborn
• Male
• Treatment Outcome