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

Candidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00903526
• Other study ID #: 3423/CE
• Status: Active, not recruiting
• Phase: N/A
• First received: May 15, 2009
• Last updated: May 15, 2009
• Start date: March 2009

Study information

• Verified date: May 2009
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients diagnosed with a nosocomial candidaemia at the University Hospital of Modena, Italy, between January 1998 and March 2008

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Candidemia
• Disease Susceptibility

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2009	No