Anidulafungin for the treatment of candidaemia/invasive candidiasis in selected critically ill patients.

Abstract

A prospective, multicentre, phase IIIb study with an exploratory, open-label design was conducted to evaluate efficacy and safety of anidulafungin for the treatment of candidaemia/invasive candidiasis (C/IC) in specific ICU patient populations. Adult ICU patients with confirmed C/IC meeting ≥ 1 of the following criteria were enrolled: post-abdominal surgery, solid tumour, renal/hepatic insufficiency, solid organ transplant, neutropaenia, and age ≥ 65 years. Patients received anidulafungin (200 mg on day 1, 100 mg/day thereafter) for 10-42 days, optionally followed by oral voriconazole/fluconazole. The primary efficacy endpoint was global (clinical and microbiological) response at the end of all therapy (EOT). Secondary endpoints included global response at the end of intravenous therapy (EOIVT) and at 2 and 6 weeks post-EOT, survival at day 90, and incidence of adverse events (AEs). The primary efficacy analysis was performed in the modified intent-to-treat (MITT) population, excluding unknown/missing responses. The safety and MITT populations consisted of 216 and 170 patients, respectively. The most common pathogens were Candida albicans (55.9%), C. glabrata (14.7%) and C. parapsilosis (10.0%). Global success was 69.5% (107/154; 95% CI, 61.6-76.6) at EOT, 70.7% (111/157) at EOIVT, 60.2% (77/128) at 2 weeks post-EOT, and 50.5% (55/109) at 6 weeks post-EOT. When unknown/missing responses were included as failures, the respective success rates were 62.9%, 65.3%, 45.3% and 32.4%. Survival at day 90 was 53.8%. Treatment-related AEs occurred in 33/216 (15.3%) patients, four (1.9%) of whom had serious AEs. Anidulafungin was effective, safe and well tolerated for the treatment of C/IC in selected groups of ICU patients.

• Authors: M Ruhnke, J A Paiva, W Meersseman, J Pachl, I Grigoras, G Sganga, F Menichetti, P Montravers, G Auzinger, G Dimopoulos, M Borges Sá, P J Miller, T Marček, M Kantecki
• Journal: Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases (Clin Microbiol Infect) Vol. 18 Issue 7 Pg. 680-7 (Jul 2012) ISSN: 1469-0691 [Electronic] England
• PMID: 22404732 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study)
• Copyright: © 2012 Pfizer Inc. Clinical Microbiology and Infection © 2012 European Society of Clinical Microbiology and Infectious Diseases.

Chemical References

• Antifungal Agents
• Echinocandins
• Pyrimidines
• Triazoles
• Fluconazole
• Anidulafungin
• Voriconazole

Topics

• Adult
• Aged
• Aged, 80 and over
• Anidulafungin
• Antifungal Agents (adverse effects, therapeutic use)
• Candida (classification, isolation & purification)
• Candidiasis, Invasive (drug therapy)
• Critical Illness
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Echinocandins (administration & dosage, adverse effects)
• Female
• Fluconazole (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Prospective Studies
• Pyrimidines (administration & dosage, adverse effects)
• Treatment Outcome
• Triazoles (administration & dosage, adverse effects)
• Voriconazole