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Prevalence and Epidemiology of Nosocomial Candidaemia and Antifungal Susceptibility Patterns in an Italian Tertiary-Care Hospital

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by University of Modena and Reggio Emilia.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903526
First Posted: May 18, 2009
Last Update Posted: May 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Modena and Reggio Emilia
  Purpose
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.

Condition
Candidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence and Epidemiology of Nosocomial Candidaemia and Antifungal Susceptibility Patterns in an Italian Tertiary-Care Hospital

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: March 2009
Groups/Cohorts
candidemia

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • patients diagnosed with a nosocomial candidaemia at the University Hospital of Modena, Italy, between January 1998 and March 2008
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr Giovanni Guaraldi/ Dr Mauro Codeluppi, Infectoius Disease Clinic
ClinicalTrials.gov Identifier: NCT00903526     History of Changes
Other Study ID Numbers: 3423/CE
First Submitted: May 15, 2009
First Posted: May 18, 2009
Last Update Posted: May 18, 2009
Last Verified: May 2009

Keywords provided by University of Modena and Reggio Emilia:
fungal susceptibility

Additional relevant MeSH terms:
Disease Susceptibility
Candidemia
Disease Attributes
Pathologic Processes
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Antifungal Agents
Miconazole
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors