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| ID | Type | Description | Link |
|---|---|---|---|
| 2013 A00756 39 | Other Identifier | ID-RCB number, ANSM |
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The investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in ICU patients.
The duration of empirical/preemptive anti fungal treatment will be based in the intervention group on biomarker results.
Biomarkers of fungal disease will performed before starting anti fungal treatment and at day 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biomarker group | Experimental | Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers. Biomarker group |
|
| Control group | No Intervention | Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker group | Other | use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies) |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of early discontinuation of empiric antifungal therapy | Early discontinuation is defined as discontinuation of anti fungal treatment before the 7th day after the start of treatment | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| mortality in ICU | death during the 28 days following ICU admission | 28 days after ICU admission |
| duration of mechanical ventilation and ICU stay | mechanical ventilation duration during the 28 days following ICU admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad Nseir, MD, PhD | Univ Hosp of Lille, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU, Salengro Hospital, University Hospital of Lille | Lille | Nord | 59035 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28936678 | Result | Rouze A, Loridant S, Poissy J, Dervaux B, Sendid B, Cornu M, Nseir S; S-TAFE study group. Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: a randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1668-1677. doi: 10.1007/s00134-017-4932-8. Epub 2017 Sep 22. |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| D016638 | Critical Illness |
| D000072742 | Invasive Fungal Infections |
| C536972 | Torulopsis |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| 28 days after ICU admission |
| fungal colonization / infection after antifungal therapy, with or without resistant strains | Any fungal colonization or infection diagnosed during the 28 days following ICU admission | 28 days after ICU admission |
| the cost of the antifungal therapy on a per duration prescribe | 28 days after ICU admission |
| the cost of hospital stays | 28 days after ICU admission |
| D013568 |
| Pathological Conditions, Signs and Symptoms |