Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs in Patients With Hematological Diseases in China

NCT05002582 | Unknown DMC

• 1 other identifier: SRRSH-CROSS
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Carbapenem-resistant Organisms; colonization; hematological diseases; rectal swabs

Outcome Measures

Primary Outcomes (1)

• CRO intestinal colonization incidence

  Positive culture any of these three organsisms: Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB)

  1 year since enrollment

Secondary Outcomes (1)

• Bloodstream infection incidence

  1 year after enrollment

Study Arms (1)

patients with hematological diseases

to clarify the intestinal carriage rate of carbapenem-resistant Organisms (CRO) in patients with hematological diseases

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study focused on the colonization rate of Carbapenem-resistant Organisms (CRO) in the intestine of Chinese patients with hematological malignancies diseases, who 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.

You may qualify if:

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

You may not qualify if:

• Patients or their legal representatives refused to enter the study
• Patients died because of hematological malignancies diseases.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

Related Publications (2)

• Hu H, Huang W, Ruan S, Zhou J, Wang Y, Weng R, Shi Q, Jiang Y, Jin X, Yu Y. Intestinal colonization of carbapenem-resistant gram-negative bacteria in pediatric hematology patients: risk factors and molecular characteristics, a multicenter case-control study. BMC Microbiol. 2025 Dec 17;25(1):794. doi: 10.1186/s12866-025-04533-z.

  PMID: 41408155 DERIVED

• 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.

  PMID: 38847538 DERIVED

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Yunsong YU, MD

  Zhejiang University school of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingzhi Fang, MD

CONTACT

+86 571 86006811; fyz4817@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)