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

December 3, 2010 updated by: Southeast University, China

Epidemiology of Invasive Candida Infections in Critically Ill Patients: A Multicenter, Prospective, Observational Study in China

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Gulou District
        • Contact:

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult ICU patients above 18 with invasive candida infection

Description

Inclusion criteria:

-Adult ICU patients above 18 with ICI-

Exclusion criteria:

-Non ICI-

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

Cohorts and Interventions

Group / Cohort
ICU patients with IFI
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the current incidence and in-hospital mortality of invasive candidas infection in ICUs in China.
Time Frame: 300 charactors
300 charactors

Secondary Outcome Measures

Outcome Measure
Time Frame
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
300 charactors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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

November 1, 2009

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2010

Last Update Submitted That Met QC Criteria

December 3, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 1234 (Department of Defense)

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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