NCT01773876CompletedPhase 3
Micafungin Versus Placebo in the Nosocomial Sepsis in Patients Multi-colonized With Candida, Randomized Controlled Trial
University Hospital, Grenoble22 sites in 1 country260 target enrollmentStarted: July 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 260
- Locations
- 22
- Primary Endpoint
- survival to 28 days without proven fungal infection (a fungal infection occurring within 48 hours after inclusion will be considered available for inclusion)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Persistent sepsis without documented invasive candidiasis:
- •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
- •Hospitalization in intensive care for over 5 days (120 hours)
- •Giving a free, informed and in writing. In the absence of the person of trust or a family member (if present)consent to emergency possible.
- •Receiving a social security system,
- •Negative pregnancy test for patients of childbearing age
Exclusion Criteria
- •Proven invasive fungal infection (positive blood culture, positive culture of a surgical site, deep biopsy with fungal infection), including aspergillosis requiring antifungal therapy at the time of randomization
- •Prognosis of less than 48 hours (for which the patient outcome will be fatal whatever treatment),
- •Echinocandin antifungal treatment by more than one day or another antifungal for over 72 hours in the week before the inclusion visit,
- •Allergy, hypersensitivity or known intolerance to echinocandins antifungal or any of the excipients of the drug
- •Neutropenia (ANC <500/mm3)
- •History of organ and bone marrow,
- •Recent chemotherapy (less than 6 months)
- •Systemic immunosuppressive therapy in progress, other than with corticosteroids at doses below 2 mg / kg / day of prednisolone or equivalent
- •Participation in another interventional study in the same ICU stay or making treatment being evaluated within 28 days prior to randomization
- •Any clinical investigator deems incompatible with the conduct of the study in acceptable security conditions
- •Pregnant and lactating women,
- •Adults subject to a legal protection measure
- •Persons deprived of their liberty by a judicial or administrative decision, those hospitalized without consent, persons admitted to a health facility or social purposes other than research
Arms & Interventions
Micafungin
Active Comparator
MYCAMINE 100 mg intravenous an injection of 24 hours
Intervention: Micafungin (Drug)
PLACEBO
Placebo Comparator
0.9% sodium chlorides 100ml infusion
Intervention: PLACEBO (Drug)
Outcomes
Primary Outcomes
survival to 28 days without proven fungal infection (a fungal infection occurring within 48 hours after inclusion will be considered available for inclusion)
Time Frame: 28 days follow-up
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.
Secondary Outcomes
- pharmacokinetic parameters: estimated gross exposure indices: AUC, Cmax, Cmin(during 24 hours (between the two first infusions))
- evaluation of tolerance(3 months)
- pharmacodynamic parameters: potential serum biomarkers of treatment efficacy (PCR Candida,1,3 β-D-glucan,mannan antigenemia,anti-mannan,Procalcitonin (proCT))(during 28 days)
- pharmacodynamic parameters: Early prognostic factors of response: J7 survival without proven invasive candidiasis(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)(during 90 days)
- Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis can free survival antifungal treatment at day 28(during 28 days)
- Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis possible evolution of organ failure during the study(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(during 90 days)
- Evaluate the impact of empiric treatment with micafungin in patients with invasive candidiasis possible evolution of the colonization index during study(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(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).(during 90 days)
Investigators
Study Sites (22)
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