A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China (china-scan)
Recruitment status was Recruiting
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 3, 2010 |
| Last Updated Date | December 3, 2010 |
| Start Date ICMJE | November 2009 |
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE |
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 ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China |
| Official Title ICMJE | Epidemiology of Invasive Candida Infections in Critically Ill Patients: A Multicenter, Prospective, Observational Study in 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 Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Adult ICU patients above 18 with invasive candida infection |
| Condition ICMJE | Candidiasis |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | ICU patients with IFI
1 |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 300 |
| Estimated Completion Date | April 2011 |
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion criteria: -Adult ICU patients above 18 with ICI- Exclusion criteria: -Non ICI- |
| Gender | Both |
| Ages | 18 Years to 85 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | China |
| Administrative Information | |
| NCT Number ICMJE | NCT01253954 |
| Other Study ID Numbers ICMJE | 1234 |
| Has Data Monitoring Committee | No |
| Responsible Party | Haibo Qiu, Southeast University |
| Study Sponsor ICMJE | Southeast University, China |
| Collaborators ICMJE | QLT Inc. |
| Investigators ICMJE | Not Provided |
| Information Provided By | Southeast University, China |
| Verification Date | November 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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