A Phase 3 interventional study of caspofungin antifungal therapy and placebo in ICU Yeast Intra-abdominal Infection, sponsored by Centre Hospitalier Universitaire, Amiens. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 3, Interventional, and Treatment
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.
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This study's planned enrollment of 448 is above the median of 99 across 191 interventional studies indexed under Candidiasis.
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Admitted to ICU after surgery for intra-abdominal infection :
Exclusion Criteria:
placebo
Other: placebo
caspofungin
Drug: caspofungin antifungal therapy
caspofungin
placebo
failure 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
Plan to share: No
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This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire, Amiens →