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A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China (china-scan)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Southeast University, China.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
QLT Inc.
Information provided by:
Southeast University, China
ClinicalTrials.gov Identifier:
NCT01253954
First received: December 3, 2010
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

The incidence of invasive candida infection (ICI) in critically ill patients is increasing day by day. The crude mortality of IFI in ICU could be as high as 25%-75% depending on their age, underlying conditions, and so on. Candida albicans was by far the predominant species in most countries, causing up to two thirds of all cases of invasive candidiasis. However, a shift toward non-albicans Candida species has been observed. Although the studies of ICI cause universal attention recently, there is still no large-scale, multi-center epidemiological research in China focusing on ICI in critically ill patients, therefore we conducted a large-scale multi-center observational study of IFI in critically ill patients named "China Scan" (CHINA Survey of Candidiasis in ICU) to assess the current incidence, mortality, pathogen spectrum, management, and risk factors for ICI in China ICUs.


Condition
Candidiasis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiology of Invasive Candida Infections in Critically Ill Patients: A Multicenter, Prospective, Observational Study in China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Determine the current incidence and in-hospital mortality of invasive candidas infection in ICUs in China. [ Time Frame: 300 charactors ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe the risk factors for ICI in China ICUs. Explore the pathogen spectrum of ICI in ICUs in China. Describe the in vitro antifungal susceptibility of Candida isolates. Describe the antifungal treatment for ICU patients with ICI. [ Time Frame: 300 charactors ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICU patients with IFI
1

Detailed Description:

Background of the study:

The incidence of invasive candida infection (ICI) in critically ill patients is increasing day by day. The crude mortality of ICI in ICU could be as high as 25%-75% depending on their age, underlying conditions, and so on. Candida albicans was by far the predominant species in most countries, causing up to two thirds of all cases of invasive candidiasis. However, a shift toward non-albicans Candida species has been observed. Although the studies of ICI cause universal attention recently, there is still no large-scale, multi-center epidemiological research in China focusing on IFI in critically ill patients, therefore we conducted a large-scale multi-center observational study of IFI in critically ill patients named "China Scan" (CHINA Survey of Candidiasis in ICU) to assess the current incidence, mortality, pathogen spectrum, management, and risk factors for ICI in China ICUs.

Objective of the study:

Determine the current incidence of IFI in ICUs in China. Describe the risk factors for IFI in China ICUs. Explore the pathogen spectrum of IFI in ICUs in China. Describe the in vitro antifungal susceptibility of Candida isolates. Describe the antifungal treatment for ICU patients with IFI. Evaluate in-hospital mortality among patients with IFI in ICUs.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult ICU patients above 18 with invasive candida infection

Criteria

Inclusion criteria:

-Adult ICU patients above 18 with ICI-

Exclusion criteria:

-Non ICI-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253954

Locations
China, Jiangsu
Gulou District Recruiting
Nanjing, Jiangsu, China, 210009
Contact: GUO F M, Dr     86-10-02583272201     fmguo2003@yahoo.com.cn    
Sponsors and Collaborators
Southeast University, China
QLT Inc.
  More Information

No publications provided

Responsible Party: Haibo Qiu, Southeast University
ClinicalTrials.gov Identifier: NCT01253954     History of Changes
Other Study ID Numbers: 1234
Study First Received: December 3, 2010
Last Updated: December 3, 2010
Health Authority: China: Ethics Committee

Keywords provided by Southeast University, China:
invasive candida infection

Additional relevant MeSH terms:
Candidiasis
Mycoses

ClinicalTrials.gov processed this record on June 18, 2013