Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs in Patients With Hematological Diseases in China
NCT ID: NCT05002582
Last Updated: 2021-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5000 participants
OBSERVATIONAL
2021-01-01
2022-12-31
Brief Summary
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Previous studies show that in China, patients with hematological disease are at high-risk of CRE colonization and infection, but there still lack the data of colonization rate of CRPA and CRAB in patients with hematological disease. Intestinal flora is not only an important micro-ecological environment for the human body, but also an important place for the habitation of multidrug-resistant bacteria. The colonization of these bacteria can not only lead to the spread of bacteria in hospital, but also may lead to the translocation infection of carriers. Patients with hematological diseases are often in a state of neutropenia after chemotherapy. At the same time, chemotherapy drugs and various factors can cause intestinal mucosa damage, which is prone to induce intestinal microflora translocation, causing serious infections such as sepsis, and posing a serious threat to the prognosis of patients. Early detection of CRO carriers is not only beneficial to the control of nosocomial infection, but also beneficial to early precise anti-infection treatments, reducing the probability of infection and improving the prognosis of infected patients.
Our study is designed to clarify the intestinal carriage rate of carbapenem-resistant Organisms (CRO) in patients with hematological diseases, and the risk factors of intestinal CRO colonization in patients with hematological diseases and its correlation with subsequent infections. 5000 patients diagnosed with hematological diseases will be enrolled, and rectal swabs or feces will be collected to detect the CRE intestinal colonization. Subsequently, the last 6 months clinical data of CRO-colonized patients and matched non CRO-colonized patients (1:1) will be collected. Then, the randomly selected 200 CRO-colonized patients and matched 200 non CRO-colonized patients (1:1) are followed up for 12 months, a total of 400 patients will be enrolled. Every month, rectal swabs and relevant clinical data will be collected.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with hematological diseases
to clarify the intestinal carriage rate of carbapenem-resistant Organisms (CRO) in patients with hematological diseases
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients died because of hematological malignancies diseases.
18 Years
90 Years
ALL
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
Responsible Party
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Jian-cang Zhou M.D.
Professor
Principal Investigators
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Yunsong YU, MD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University school of medicine
Locations
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Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Ying-zhi Fang
Role: primary
References
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Hu H, Wang Y, Sun J, Wang Y, Zhou J, Shi Q, Han X, Jiang Y, Wu D, Huang X, Yu Y. Risk factors and molecular epidemiology of intestinal colonization by carbapenem-resistant Gram-negative bacteria in patients with hematological diseases: a multicenter case-control study. Microbiol Spectr. 2024 Jul 2;12(7):e0429923. doi: 10.1128/spectrum.04299-23. Epub 2024 Jun 7.
Other Identifiers
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SRRSH-CROSS
Identifier Type: -
Identifier Source: org_study_id
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