Hematological DiseasesCROSSNCT05002582
Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs in Patients With Hematological Diseases in China
An observational study of Hematological Diseases and Carbapenem-resistant Enterobacteriaceae, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Carbapenem-resistant Organisms (CRO) include Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hematological Diseases, Carbapenem-resistant Enterobacteriaceae, Carbapenem-resistant Pseudomonas Aeruginosa
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- On a certain day in each chosed hospital, all the inpatients diagnosed with hematological malignancies diseases will be enrolled
Who cannot join
- Patients or their legal representatives refused to enter the study
- Patients died because of hematological malignancies diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Ying-zhi Fang, +86 571 86006987
Yun-song Yu, M.D.
About this study
Official title: Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs and the Relationship Between Colonization and Infection in Patients With Hematological Diseases in China
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
- Medical subject headings
- Hematologic Diseases
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 |
|---|---|---|
| patients with hematological diseases | to clarify the intestinal carriage rate of carbapenem-resistant Organisms (CRO) in patients with hematological diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year since enrollment
Secondary outcomes (1)
Bloodstream infection incidence
Blood postive culture of the same organisms found in the rectal swabs
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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 Hematological DiseasesStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-cang Zhou M.D., Sir Run Run Shaw Hospital
- Investigators
- Yunsong YU, MD, Principal investigator, Zhejiang University school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002582
- Sponsor's protocol ID
- SRRSH-CROSS
- Acronym
- CROSS
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41408155Hu 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.
PubMed 38847538
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs and the Relationship Between Colonization and Infection in Patients With Hematological Diseases in China
- ClinicalTrials.gov ID
- NCT05002582
- Acronym / sponsor ID
- CROSS / SRRSH-CROSS
- Conditions
- Hematological Diseases, Carbapenem-resistant Enterobacteriaceae, Carbapenem-resistant Pseudomonas Aeruginosa, Carbapenem-resistant Acinetobacter Baumannii
- Keywords
- Carbapenem-resistant Organisms, colonization, hematological diseases, rectal swabs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Aug 2021 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with hematological diseases | – | –to clarify the intestinal carriage rate of carbapenem-resistant Organisms (CRO) in patients with hematological diseases |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- On a certain day in each chosed hospital, all the inpatients diagnosed with hematological malignancies diseases will be enrolled
Key exclusion criteria (2 listed)
- Patients or their legal representatives refused to enter the study
- Patients died because of hematological malignancies diseases.
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
CRO intestinal colonization incidence
Time frame: 1 year since enrollment
Positive culture any of these three organsisms: Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB)
1 secondary outcome
Bloodstream infection incidence
Time frame: 1 year after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 41408155Hu 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.
- Derived from this study: PubMed 38847538Hu 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.
- Individual participant dataSharing planned: No
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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.
Yunsong YU, MD principal investigator
Zhejiang University school of medicine
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 Hematological Diseases and Carbapenem-resistant Enterobacteriaceae, run by Sir Run Run Shaw Hospital 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 2 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 12 Aug 2021. 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?
Contact Yingzhi Fang, MD (+86 571 86006811, fyz4817@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRO intestinal colonization incidence (time frame: 1 year since enrollment). 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 NCT05002582, 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 12 Aug 2021.