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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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Carbapenem-resistant Organisms (CRO) include Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB). Due to the high fatality rate of CRO infection, and its potential for wide spread, it is currently one of the issues that seriously affect the global public health safety. In 2019, CDC of the United States listed CRE and CRAB as the highest level of "antibiotic-resistant bacteria with urgent threat", while CRPA was listed as "antibiotic-resistant bacteria with serious threat".

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.

Detailed Description

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Conditions

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Hematological Diseases Carbapenem-resistant Enterobacteriaceae Carbapenem-resistant Pseudomonas Aeruginosa Carbapenem-resistant Acinetobacter Baumannii

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* On a certain day in each chosed hospital, all the inpatients diagnosed with hematological malignancies diseases will be enrolled

Exclusion Criteria

* Patients or their legal representatives refused to enter the study
* Patients died because of hematological malignancies diseases.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian-cang Zhou M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingzhi Fang, MD

Role: CONTACT

+86 571 86006811

Facility Contacts

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Ying-zhi Fang

Role: primary

+86 571 86006987

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.

Reference Type DERIVED
PMID: 38847538 (View on PubMed)

Other Identifiers

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SRRSH-CROSS

Identifier Type: -

Identifier Source: org_study_id

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