NCT01773876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2012

Typical duration for phase_3

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

January 14, 2013

Last Update Submit

March 23, 2015

Conditions

Invasive Candidiasis

Keywords

survival without proven invasive candidiasiseffectivenessmicafungin versus placebopharmacokineticpharmacodynamictolerance

Outcome Measures

Primary Outcomes (1)

  • 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.

    28 days follow-up

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Micafungin

ACTIVE COMPARATOR

MYCAMINE 100 mg intravenous an injection of 24 hours

Drug: Micafungin

PLACEBO

PLACEBO COMPARATOR

0.9% sodium chlorides 100ml infusion

Drug: PLACEBO

Interventions

MicafunginDRUG

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

Micafungin
PLACEBODRUG

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

PLACEBO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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),
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Hospital Aix en Provence

Aix-en-Provence, 13616, France

Location

Hospital University of Besançon

Besançon, 67091, France

Location

University Hospital of Avicennes

Bobigny, 93009, France

Location

Hospital University of Bordeaux

Bordeaux, 33000, France

Location

Hospital University of Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

University Hospital of Beaujon

Clichy, 92110, France

Location

University Hospital of Dijon

Dijon, 21000, France

Location

Hospital of Draguignan

Draguignan, 83300, France

Location

Hospital University of Grenoble

Grenoble, 38043, France

Location

Departemental Hospital of Roche sur Yon

La Roche-sur-Yon, 85925, France

Location

Hospital of Versailles

Le Chesnay, 78150, France

Location

University Hospital Edouard Herriot

Lyon, 96433, France

Location

Hospital University of Montpellier

Montpellier, 34295, France

Location

Interegional Hospital André Grégoire

Montreuil, 93105, France

Location

University Hospital Saint Louis

Paris, 75010, France

Location

University Hospital of La Pitié Salpetrière

Paris, 75013, France

Location

Hospital St Joseph

Paris, 75014, France

Location

Hospital University of Bichat

Paris, 75877, France

Location

Hospital of Pontoise

Pontoise, 95303, France

Location

Hospital University of Reims

Reims, 51092, France

Location

University Hospital of Saint Etienne

Saint-Etienne, 42055, France

Location

University Hospital of Strasbourg

Strasbourg, 67091, France

Location

Related Publications (2)

  • Timsit JF, Azoulay E, Schwebel C, Charles PE, Cornet M, Souweine B, Klouche K, Jaber S, Trouillet JL, Bruneel F, Argaud L, Cousson J, Meziani F, Gruson D, Paris A, Darmon M, Garrouste-Orgeas M, Navellou JC, Foucrier A, Allaouchiche B, Das V, Gangneux JP, Ruckly S, Maubon D, Jullien V, Wolff M; EMPIRICUS Trial Group. Empirical Micafungin Treatment and Survival Without Invasive Fungal Infection in Adults With ICU-Acquired Sepsis, Candida Colonization, and Multiple Organ Failure: The EMPIRICUS Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1555-1564. doi: 10.1001/jama.2016.14655.

    PMID: 27706483DERIVED

  • Timsit JF, Azoulay E, Cornet M, Gangneux JP, Jullien V, Vesin A, Schir E, Wolff M. EMPIRICUS micafungin versus placebo during nosocomial sepsis in Candida multi-colonized ICU patients with multiple organ failures: study protocol for a randomized controlled trial. Trials. 2013 Nov 21;14:399. doi: 10.1186/1745-6215-14-399.

    PMID: 24261608DERIVED

MeSH Terms

Conditions

Candidiasis, Invasive

Interventions

Micafungin

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal Infections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • TIMSIT JFT Jean François, PU-PH

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 23, 2013

Study Start

July 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

FR(22)