The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. Prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. The aim of this study is to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.
The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. These infections are clearly associated with increased morbidity and mortality in both community-acquired and healthcare-associated infections. So far,prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. No prospective randomized trial has been conducted on intra-abdominal candidiasis and most retrospective analyses have reported very conflicting results concerning the impact of treatment on outcome. The aim of this study is therefore to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
448
caspofungin
placebo
CHU Amiens
Amiens, France
RECRUITINGfailure rate after the beginning of treatment
28-day failure rate after the beginning of treatment
Time frame: 28 days
mortality
28 and 90-day mortality rate
Time frame: 28 and 90 days
success rate at the end of treatment
success rate at the end of treatment
Time frame: 8 days
slope of ß-D-glucan concentrations
slope of ß-D-glucan concentrations
Time frame: 8 days
mortality
28- 28 day mortality for subgroup analysis
Time frame: 28 days
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