Text Size

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
  Purpose

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.


Condition
Invasive Mycosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Web-based Structured Survey of Retrospective Data of Invasive Mycosis in Intensive Care Patients in Berlin - Brandenburg

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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



Estimated Enrollment: 12
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
INABBRA
Participating hospitals in the INABBRA alliance.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hospitals without intensive care unit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393002

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Claudia Spies, Prof., MD Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
  More Information

Additional Information:
Homepage of the INABBRA alliance with its description.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01393002     History of Changes
Other Study ID Numbers: IFI_ICU
Study First Received: July 5, 2011
Last Updated: July 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
intensive care
candidemia
fungal infection

Additional relevant MeSH terms:
Mycoses

ClinicalTrials.gov processed this record on May 16, 2013