- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00903526
Prevalence and Epidemiology of Nosocomial Candidaemia and Antifungal Susceptibility Patterns in an Italian Tertiary-Care Hospital
May 15, 2009 updated by: University of Modena and Reggio Emilia
During the past two decades, the frequency of invasive fungal infections has increased dramatically in hospitalised patients throughout the world, and Candida has now emerged as one of the leading causes of bloodstream infections (BSIs).
Risk-factors for invasive candidiasis include improvements in intensive care strategies (i.e., central venous catheters, mechanical ventilation, hyper-alimentation), prolonged stays in intensive care units (ICUs), the development of more aggressive surgical techniques, and the prolongation of survival of critically-ill patients.
Two other important factors, observed mainly in cancer patients, are colonization of mucous membranes by yeasts, and neutropenia, resulting from increased use of antibiotics and anti-neoplastic agents, respectively.
The crude mortality rate of candidaemia is high (38-75%), and the attributable mortality has been estimated at 25-38%.
During the past 15 years, the prevalence of infections caused by non-albicans Candida spp.
has increased exponentially, so that these organisms now account for > 50% of episodes of fungaemia in various surveys.
The increase in invasive fungal infections, the associated high mortality rate, and the emergence of antifungal resistance, have all driven the search for more potent antifungal drugs.
The aims of the present study are to investigate the prevalence and the epidemiology of candidaemia and to determine the antifungal susceptibility patterns of Candida spp.
isolates from a tertiary-care hospital in Italy.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
250
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients diagnosed with a nosocomial candidaemia at the University Hospital of Modena, Italy, between January 1998 and March 2008
Description
Inclusion Criteria:
- patients diagnosed with a nosocomial candidaemia at the University Hospital of Modena, Italy, between January 1998 and March 2008
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
candidemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The aims of the present study are to investigate the prevalence and the epidemiology of candidaemia and to determine the antifungal susceptibility patterns of Candida spp. isolates from a tertiary-care hospital in Italy.
Time Frame: 2009
|
2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Study Registration Dates
First Submitted
May 15, 2009
First Submitted That Met QC Criteria
May 15, 2009
First Posted (Estimate)
May 18, 2009
Study Record Updates
Last Update Posted (Estimate)
May 18, 2009
Last Update Submitted That Met QC Criteria
May 15, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3423/CE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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