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EMPIRICUS micafungin versus placebo during nosocomial sepsis in Candida multi-colonized ICU patients with multiple
Jean-François Timsit1, Elie Azoulay, Muriel Cornet
1University Grenoble 1, Intensive Care Unit, Albert Michallon Hospital, BP 217, 38043 Grenoble, Cedex 9, France. JFTimsit@chu-grenoble.fr.
Background:
The potential interest of antifungal treatment of non-immunocompromized patients with sepsis, extra-digestive Candida colonization and multiple organ failure is unknown. It represents three-quarters of antifungals prescribed in Intensive Care Units. It may allow early treatment of invasive fungal infection in the incubation phase but expose patients to unnecessary antifungal treatments with subsequent cost and fungal selection pressure. As early diagnostic tests for invasive candidiasis are still considered to be insufficient, the potential interest in this strategy needs to be demonstrated.
Methods:
This prospective multicenter, double blind, randomized-controlled trial is conducted in 23 French Intensive Care Units. All adult patients, mechanically ventilated for more than four days with sepsis of unknown origin and with at least one extradigestive fungal colonization site and multiple organ failure are eligible for randomization. Patients with proven invasive candidiasis are not included. After a complete mycological screening, patients are allocated to receive micafungin 100 mg intravenously once a day or placebo for 14 days. We plan to enroll 260 patients. The main objective is to demonstrate that micafungin increases survival of patients without invasive candidiasis at day 28 as compared to placebo. Other outcomes include day 28 and 90 survival and organ failure evolution. Additionally, pharmacokinetics of micafungin in enrolled patients will be measured and evolution of fungal biomarkers and susceptibility profiles of infecting fungi will also be followed.
Discussion:
This study will help to provide guidelines for treating non-immunocompromized patients with fungal colonization multiple organ failure and sepsis of unknown origin.
Trial Registration:
Clinicaltrials.gov number NCT01773876.
Insights
This trial investigates micafungin for non-immunocompromized patients with sepsis and fungal colonization. It aims to determine if early antifungal treatment improves survival without invasive candidiasis.
Area of Science:
- Critical Care Medicine
- Infectious Diseases
- Clinical Pharmacology
Background:
- Sepsis with extra-digestive Candida colonization and multiple organ failure is common in Intensive Care Units.
- Antifungal use in these patients is high, but the benefit of treating colonization without proven invasive fungal infection is unclear.
- Early diagnosis of invasive candidiasis remains challenging, necessitating research into empirical treatment strategies.
Purpose of the Study:
- To evaluate the efficacy of micafungin in improving survival for non-immunocompromized patients with sepsis, fungal colonization, and multiple organ failure.
- To assess the impact of micafungin on 28-day and 90-day survival rates and organ failure progression.
- To analyze the pharmacokinetics of micafungin and monitor changes in fungal biomarkers and susceptibility.
Main Methods:
- A prospective, multicenter, double-blind, randomized controlled trial involving 260 adult patients in 23 French Intensive Care Units.
- Patients with sepsis of unknown origin, mechanical ventilation >4 days, extradigestive fungal colonization, and multiple organ failure were randomized to micafungin or placebo for 14 days.
- Exclusion criteria included proven invasive candidiasis. Mycological screening was performed prior to randomization.
Main Results:
- The primary endpoint is to demonstrate increased survival at day 28 in the micafungin group compared to placebo among patients without invasive candidiasis.
- Secondary endpoints include survival at day 90 and the evolution of organ failure.
- Pharmacokinetic data, fungal biomarker evolution, and changes in fungal susceptibility profiles will also be analyzed.
Conclusions:
- This study aims to provide evidence-based guidelines for the management of non-immunocompromized patients with sepsis, fungal colonization, and multiple organ failure.
- Findings will inform clinical decisions regarding the use of antifungal agents in this specific patient population.
- The trial will contribute to understanding the risks and benefits of empirical antifungal therapy in intensive care settings.
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