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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01393002
Other study ID # IFI_ICU
Secondary ID
Status Completed
Phase N/A
First received July 5, 2011
Last updated October 17, 2013
Start date July 2011
Est. completion date July 2013

Study information

Verified date October 2013
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

This is a structured web-based survey in selected hospitals with intensive care units in Berlin- Brandenburg that will focus on the analysis of current knowledge in ICUs in the field of invasive mycoses.


Description:

Intensive care patients with invasive mycosis require a special clinical expertise especially in light of a high lethality. Early identification of patients at risk to develop a fungal infection is of utmost importance to start effective antifungal therapy. The implementation of current knowledge into clinical practice to fight fungal infection is not clear.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date July 2013
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Intensive care units of hospitals in the INABBRA alliance.

- Patients with invasive mycosis.

Exclusion Criteria:

- Hospitals without intensive care unit.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Morrell M, Fraser VJ, Kollef MH. Delaying the empiric treatment of candida bloodstream infection until positive blood culture results are obtained: a potential risk factor for hospital mortality. Antimicrob Agents Chemother. 2005 Sep;49(9):3640-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Perception and prevalence of fungal infections Perception and prevalence of fungal infections in ICU patients differs from real prevalence and leads to insufficient attribution of importance to this special medical condition. 4 months No
Secondary Practice - Surrogate markers for diagnosis and therapy of fungal infection and retrospective analysis of cases of invasive mycosis in a peer-review setting. Qualitative and quantitative estimation of surrogate markers for diagnosis and treatment of invasive mycosis
Number of bloodcultures per year Rate of bloodcultures positive for fungi ICD-10 diagnosis ICU length of stay for patients with invasive mycosis and/or fungal infection Hospital mortality for patients with invasive mycosis and/or fungal infection Number of patients treated by antimycotics per year Mean duration of antifungal treatment Defined daily doses of antimycotics given by hospital pharmacy
6 months No
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