Empirical Antifungal Treatment in ICUS (NCT01773876) | Clinical Trial Compass
CompletedPhase 3
Empirical Antifungal Treatment in ICUS
France260 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 funga…
What they're measuring
1
survival to 28 days without proven fungal infection (a fungal infection occurring within 48 hours after inclusion will be considered available for inclusion)