A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China

• Conditions: Candidiasis

• Registration Number: NCT01253954
• Lead Sponsor: Southeast University, China

Brief Summary

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.

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 Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Last Update Submitted: 2010-12-03
• Study First Posted: 2010-12-06
• Last Update Posted: 2010-12-06
• Primary Completion: 2011-04
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the current incidence and in-hospital mortality of invasive candidas infection in ICUs in China.	300 charactors

Secondary Outcome Measures

Name	Time	Method
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.	300 charactors

Trial Locations

Locations (1)

Gulou District; 🇨🇳 Nanjing, Jiangsu, China