Empirical Antifungal Treatment in ICUS

NCT ID: NCT01773876

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-02-28

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.

Conditions

Invasive Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Micafungin

MYCAMINE 100 mg intravenous an injection of 24 hours

Group Type: ACTIVE_COMPARATOR

Micafungin

Intervention Type: DRUG

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

PLACEBO

0.9% sodium chlorides 100ml infusion

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

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

Interventions

Micafungin

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

Intervention Type: DRUG

PLACEBO

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

TIMSIT JFT Jean François, PU-PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Hospital Aix en Provence

Aix-en-Provence, , France

Hospital University of Besançon

Besançon, , France

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

Hospital of Versailles

Le Chesnay, , France

University Hospital Edouard Herriot

Lyon, , France

Hospital University of Montpellier

Montpellier, , France

Interegional Hospital André Grégoire

Montreuil, , France

University Hospital Saint Louis

Paris, , France

University Hospital of La Pitié Salpetrière

Paris, , France

Hospital St Joseph

Paris, , France

Hospital University of Bichat

Paris, , France

Hospital of Pontoise

Pontoise, , France

Hospital University of Reims

Reims, , France

University Hospital of Saint Etienne

Saint-Etienne, , France

University Hospital of Strasbourg

Strasbourg, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 27706483 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24261608 (View on PubMed)

Other Identifiers

2011-005451-14

Identifier Type: OTHER

Identifier Source: secondary_id

1126

Identifier Type: -

Identifier Source: org_study_id