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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005451-14 | Other Identifier | EudraCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micafungin | Active Comparator | MYCAMINE 100 mg intravenous an injection of 24 hours |
|
| PLACEBO | Placebo Comparator | 0.9% sodium chlorides 100ml infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetic parameters: estimated gross exposure indices: AUC, Cmax, Cmin | Reports AUC / MIC and Cmax / MIC will be calculated | during 24 hours (between the two first infusions) |
| evaluation of tolerance |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| TIMSIT JFT Jean François, PU-PH | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Aix en Provence | Aix-en-Provence | 13616 | France | |||
| Hospital University of Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27706483 | Derived | 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. | |
| 24261608 |
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| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| PLACEBO | 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 |
|
For all patients who received at least one dose of treatment:
| 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 |
| Besançon |
| 67091 |
| France |
| University Hospital of Avicennes | Bobigny | 93009 | France |
| Hospital University of Bordeaux | Bordeaux | 33000 | France |
| Hospital University of Clermont Ferrand | Clermont-Ferrand | 63003 | France |
| University Hospital of Beaujon | Clichy | 92110 | France |
| University Hospital of Dijon | Dijon | 21000 | France |
| Hospital of Draguignan | Draguignan | 83300 | France |
| Hospital University of Grenoble | Grenoble | 38043 | France |
| Departemental Hospital of Roche sur Yon | La Roche-sur-Yon | 85925 | France |
| Hospital of Versailles | Le Chesnay | 78150 | France |
| University Hospital Edouard Herriot | Lyon | 96433 | France |
| Hospital University of Montpellier | Montpellier | 34295 | France |
| Interegional Hospital André Grégoire | Montreuil | 93105 | France |
| University Hospital Saint Louis | Paris | 75010 | France |
| University Hospital of La Pitié Salpetrière | Paris | 75013 | France |
| Hospital St Joseph | Paris | 75014 | France |
| Hospital University of Bichat | Paris | 75877 | France |
| Hospital of Pontoise | Pontoise | 95303 | France |
| Hospital University of Reims | Reims | 51092 | France |
| University Hospital of Saint Etienne | Saint-Etienne | 42055 | France |
| University Hospital of Strasbourg | Strasbourg | 67091 | France |
| Derived |
| 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. |
| D000072742 |
| Invasive Fungal Infections |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |