Invasive Candida infections are burdened with a high mortality rate and is very common in intensive care units. This study aims to evaluate the efficacy of empirical treatment with micafungin in adult patients with suspected invasive candidiasis.
Multicenter, randomized, double-blind parallel groups comparing adult patients with suspected invasive candidiasis input from a 14-day empirical treatment with micafungin (MYCAMINE 100 mg) with placebo on survival without invasive candidiasis in 28 days after initiation of study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
260
MYCAMINE 100 mg intravenous 100 mg of powder reconstituted in a 100 ml infusion bag of sodium chloride 0.9% infusion over 24 hours for 14 days discontinuation of treatment if proven invasive candidiasis
solution of sodium chloride 0.9% 100 ml for intravenous infusion infusion over 24 hours for 14 days discontinuation of placebo if proven invasive candidiasis
Hospital Aix en Provence
Aix-en-Provence, France
Hospital University of Besançon
Besançon, France
survival to 28 days without proven fungal infection (a fungal infection occurring within 48 hours after inclusion will be considered available for inclusion)
breakthrough infection defined as a proven infection occurs at least 48 hours after initiation of treatment Proven infection is considered purchased after enrollment if the first significant positive levy occurs after the 48 th hour after enrollment.
Time frame: 28 days follow-up
pharmacokinetic parameters: estimated gross exposure indices: AUC, Cmax, Cmin
Reports AUC / MIC and Cmax / MIC will be calculated
Time frame: during 24 hours (between the two first infusions)
evaluation of tolerance
For all patients who received at least one dose of treatment: * number of adverse events reported after randomization up to 28 days, only death will count up to 3 months post-randomization (information on the long-term survival collected by telephone), * changes in the clinical examination, vital signs and laboratory results, * overall survival defined as the time from randomization to date of death from any cause. * Changes in liver function tests (bilirubin, ALT, AST, rate prothrombin, alkaline phosphatase) at the end of treatment and at the end study
Time frame: 3 months
pharmacodynamic parameters: potential serum biomarkers of treatment efficacy (PCR Candida,1,3 β-D-glucan,mannan antigenemia,anti-mannan,Procalcitonin (proCT))
Time frame: during 28 days
pharmacodynamic parameters: Early prognostic factors of response: J7 survival without proven invasive candidiasis
Time frame: during 14 days
Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis possible on all-cause mortality at day 28 (end of study) and J90 (3 months post-randomization)
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University Hospital of Avicennes
Bobigny, France
Hospital University of Bordeaux
Bordeaux, France
Hospital University of Clermont Ferrand
Clermont-Ferrand, France
University Hospital of Beaujon
Clichy, France
University Hospital of Dijon
Dijon, France
Hospital of Draguignan
Draguignan, France
Hospital University of Grenoble
Grenoble, France
Departemental Hospital of Roche sur Yon
La Roche-sur-Yon, France
...and 12 more locations
Time frame: during 90 days
Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis can free survival antifungal treatment at day 28
Time frame: during 28 days
Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis possible evolution of organ failure during the study
Time frame: during 90 days
Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis possible the use of mechanical ventilation during the study
Time frame: during 90 days
Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis possible evolution of the colonization index during study
Time frame: during 90 days
Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis possible changes in serum biomarkers (1-3 β-D-glucan, mannan antigenemia, anti-mannan Candida PCR) during the study
Time frame: during 90 days
Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis possible on the incidence of pneumonia acquired bacterial mechanical ventilation (VAP).
Time frame: during 90 days