A Phase 3 interventional study of Micafungin and PLACEBO in Invasive Candidiasis, sponsored by University Hospital, Grenoble. Completed at 22 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by University Hospital, Grenoble · Phase 3, Interventional, and Treatment
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.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 260 is above the median of 99 across 186 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
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systemic inflammatory response syndrome (SIRS) presence of two signs on the 4 [temperature \<36 ° C or> 38 ° C, heart rate> 90/min, respiratory rate> 20/min or PaCO2 \<32 mmHg, leukocytosis> 12,000 / mm3, \<4.000/mm3 or presence of circulating immature forms (> 10% of cells)] mechanical ventilation (intubation or tracheostomy) for over 4 days (96 hours) central line use of broad-spectrum antibacterial for more than 4 calendar days (96 hours) in the previous week presence of at least one extra-digestive site colonized by Candida sp. (Urine, mouth, throat, upper and lower respiratory tract, skin folds, and suction drains after surgery ...), not lower digestive tract, are not taken into account the positive samples of rectal swabs and / or stool cultures, absence of proven bacterial infections untreated no evidence of invasive fungal infections (positive blood culture, positive culture of a surgical site, deep biopsy with fungal) infection or mold according to the criteria of the group "fungal infection of the EORTC" organ failure
Exclusion Criteria:
MYCAMINE 100 mg intravenous an injection of 24 hours
Drug: Micafungin
0.9% sodium chlorides 100ml infusion
Drug: PLACEBO
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
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)
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
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble