Candidiasischina-scanNCT01253954
A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China
An observational study of Candidiasis, run by Southeast University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Candidiasis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients above 18 with invasive candida infection
Who may be able to join
- -Adult ICU patients above 18 with ICI-
Who cannot join
- -Non ICI-
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gulou District
Nanjing, Jiangsu, 210009
GUO F M, Dr, 86-10-02583272201, fmguo2003@yahoo.com.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Candidiasis
- Keywords
- invasive candida infection
- Medical subject headings
- Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients with IFI | 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the current incidence and in-hospital mortality of invasive candidas infection in ICUs in China.
Measured: 300 charactors
Secondary outcomes (1)
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.
Measured: 300 charactors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- QLT Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253954
- Sponsor's protocol ID
- 1234
- Acronym
- china-scan
- Status last verified
- Nov 2009
- First submitted
- 3 Dec 2010
- Last updated
- 6 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28114898Guo 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.
PubMed 23543609
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Invasive Candida Infections in Critically Ill Patients: A Multicenter, Prospective, Observational Study in China
- ClinicalTrials.gov ID
- NCT01253954
- Acronym / sponsor ID
- china-scan / 1234
- Conditions
- Candidiasis
- Keywords
- invasive candida infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- QLT Inc.
- Study start
- Nov 2009
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 6 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients with IFI | – | –1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients above 18 with invasive candida infection
Key inclusion criteria (1 listed)
- -Adult ICU patients above 18 with ICI-
Key exclusion criteria (1 listed)
- -Non ICI-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the current incidence and in-hospital mortality of invasive candidas infection in ICUs in China.
Time frame: 300 charactors
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2010.
- Derived from this study: PubMed 28114898Cui 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.
- Derived from this study: PubMed 23543609Guo 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.
Related trials for Candidiasis
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Recruiting
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
Bacterial Vaginosis, Vaginal Candidiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidiasis, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the current incidence and in-hospital mortality of invasive candidas infection in ICUs in China. (time frame: 300 charactors). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01253954, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2010.