Perception and Prevalence of Fungal Infections in Berlin - Brandenburg (IFI_ICU)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Claudia Spies, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01393002

First received: July 5, 2011

Last updated: July 9, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 5, 2011

Last Updated Date

July 9, 2012

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Perception and prevalence of fungal infections [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01393002 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Practice - Surrogate markers for diagnosis and therapy of fungal infection and retrospective analysis of cases of invasive mycosis in a peer-review setting. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Perception and Prevalence of Fungal Infections in Berlin - Brandenburg

Official Title ^ICMJE

Web-based Structured Survey of Retrospective Data of Invasive Mycosis in Intensive Care Patients in Berlin - Brandenburg

Brief 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.

Detailed 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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Intensive care units of different primary and secondary care hospitals in the region of Berlin-Brandenburg.

Condition ^ICMJE

Invasive Mycosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

INABBRA

Participating hospitals in the INABBRA alliance.

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Intensive care units of hospitals in the INABBRA alliance.
Patients with invasive mycosis.

Exclusion Criteria:

Hospitals without intensive care unit.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01393002

Other Study ID Numbers ^ICMJE

IFI_ICU

Has Data Monitoring Committee

Responsible Party

Claudia Spies, Charite University, Berlin, Germany

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Claudia Spies, Prof., MD

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin

Information Provided By

Charite University, Berlin, Germany

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top