Invasive MycosisIFI_ICUNCT01393002
Perception and Prevalence of Fungal Infections in Berlin - Brandenburg
An observational study of Invasive Mycosis, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Mycosis
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Intensive care units of different primary and secondary care hospitals in the region of Berlin-Brandenburg.
Who may be able to join
- Intensive care units of hospitals in the INABBRA alliance.
- Patients with invasive mycosis.
Who cannot join
- Hospitals without intensive care unit.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, State of Berlin, 13353
About this study
Official title: Web-based Structured Survey of Retrospective Data of Invasive Mycosis in Intensive Care Patients in Berlin - Brandenburg
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.
Read the 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.
- Conditions
- Invasive Mycosis
- Keywords
- intensive care, candidemia, fungal infection
- Medical subject headings
- Invasive Fungal Infections, Candidemia, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| INABBRA | Participating hospitals in the INABBRA alliance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive MycosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, Prof., MD, Study director, Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393002
- Sponsor's protocol ID
- IFI_ICU
- Acronym
- IFI_ICU
- Status last verified
- Oct 2013
- First submitted
- 5 Jul 2011
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1128/AAC.49.9.3640-3645.2005.
PubMed 16127033
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Structured Survey of Retrospective Data of Invasive Mycosis in Intensive Care Patients in Berlin - Brandenburg
- ClinicalTrials.gov ID
- NCT01393002
- Acronym / sponsor ID
- IFI_ICU / IFI_ICU
- Conditions
- Invasive Mycosis
- Keywords
- intensive care, candidemia, fungal infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INABBRA | – | –Participating hospitals in the INABBRA alliance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Intensive care units of different primary and secondary care hospitals in the region of Berlin-Brandenburg.
Key inclusion criteria (2 listed)
- Intensive care units of hospitals in the INABBRA alliance.
- Patients with invasive mycosis.
Key exclusion criteria (1 listed)
- Hospitals without intensive care unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perception and prevalence of fungal infections
Time frame: 4 months
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
- Background: PubMed 16127033Morrell 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. doi: 10.1128/AAC.49.9.3640-3645.2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, Prof., MD study director
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Mycosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception and prevalence of fungal infections (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01393002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2013.