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

Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs and the Relationship Between Colonization and Infection in Patients With Hematological Diseases in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05002582
Acronym
CROSS
Enrollment
5000
Registered
2021-08-12
Start date
2021-01-01
Completion date
2022-12-31
Last updated
2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

Sir Run Run Shaw Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CRO intestinal colonization incidence1 year since enrollmentPositive culture any of these three organsisms: Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB)

Secondary

MeasureTime frameDescription
Bloodstream infection incidence1 year after enrollmentBlood postive culture of the same organisms found in the rectal swabs

Countries

China

Contacts

Primary ContactYingzhi Fang, MD
fyz4817@126.com+86 571 86006811

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026