Clinical trial NCT01253954: A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China
Official title: Epidemiology of Invasive Candida Infections in Critically Ill Patients: A Multicenter, Prospective, Observational Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Candidiasis
Keywords: invasive candida infection
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: QLT Inc.
First posted: 2010-12-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU patients above 18 with invasive candida infection

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.

Eligibility criteria: Inclusion criteria:

-Adult ICU patients above 18 with ICI-

Exclusion criteria:

-Non ICI-

Primary outcomes:
measure: Determine the current incidence and in-hospital mortality of invasive candidas infection in ICUs in China.
timeFrame: 300 charactors
Secondary outcomes:
measure: 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.
timeFrame: 300 charactors
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Gulou District
state: Jiangsu
Study officials:
References:
citation: Cui N, Wang H, Su L, Qiu H, Li R, Liu D; China-SCAN Team. Initial therapeutic strategy of invasive candidiasis for intensive care unit patients: a retrospective analysis from the China-SCAN study. BMC Infect Dis. 2017 Jan 23;17(1):93. doi: 10.1186/s12879-017-2207-1.
citation: Guo F, Yang Y, Kang Y, Zang B, Cui W, Qin B, Qin Y, Fang Q, Qin T, Jiang D, Li W, Gu Q, Zhao H, Liu D, Guan X, Li J, Ma X, Yu K, Chan D, Yan J, Tang Y, Liu W, Li R, Qiu H; China-SCAN Team. Invasive candidiasis in intensive care units in China: a multicentre prospective observational study. J Antimicrob Chemother. 2013 Jul;68(7):1660-8. doi: 10.1093/jac/dkt083. Epub 2013 Mar 29.