ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONNCT07324291
Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Patients
An observational study of ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION and Carbapenem-resistant Enterobacterales, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
The goal of this observational study is to characterize the clinical features of metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) colonization and subsequent infection in patients after allogeneic hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Carbapenem-resistant Enterobacterales
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation.
Who may be able to join
- Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation;
Who cannot join
- Engraftment failure.
About this study
Official title: Prospective Cohort Study of Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients
The goal of this observational study is to characterize the clinical features of metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) colonization and subsequent infection in patients after allogeneic hematopoietic stem cell transplantation (HSCT). The study aims to estimate the incidence of perianal MBL-CRE colonization, the proportion of subsequent infections, the associated risk factors, mortality, and the underlying antibiotic resistance mechanisms.
The main questions this study seeks to answer are:
- What is the incidence of perianal MBL-CRE colonization following allogeneic HSCT?
- Among colonized patients, what proportion subsequently develop MBL-CRE infections?
- What are the risk factors for colonization and infection, the patterns of antimicrobial resistance, and the mortality among infected patients? Participants will undergo perianal swab screening for CRE as part of their routine post-transplant care. MBL-CRE isolates identified from perianal swabs will undergo antimicrobial resistance genomic analysis to investigate bacterial transmission dynamics and resistance mechanisms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perianal MBL-CRE colonization.
The proportion of patients who develop perianal colonization with metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) following allogeneic hematopoietic stem cell transplantation (HSCT).
Measured: Within 100 days after allogeneic HSCT.
Secondary outcomes (6)
Incidence of MBL-CRE Infection Among Colonized Patients.
The proportion of patients with documented perianal MBL-CRE colonization who subsequently develop MBL-CRE clinical infection.
Measured: From the time of colonization to 6 months after HSCT.
Infection-Related Mortality.
The proportion of patients with MBL-CRE infection who die due to infection-related causes within 28 days after onset of infection.
Measured: 28 days after documented onset of MBL-CRE infection.
All-Cause Mortality.
The proportion of patients with MBL-CRE infection who die from any cause within 28 days after infection onset.
Measured: 28 days after documented onset of MBL-CRE infection.
Clinical Cure Rate
The proportion of MBL-CRE-infected patients who achieve complete clinical resolution of infection-related signs and symptoms after treatment.
Measured: 28 days (range: 25-31 days) after initiation of antimicrobial therapy
Microbiological Eradication Rate.
The proportion of infected patients with documented clearance of MBL-CRE from repeat culture specimens after treatment.
Measured: 14 days (range: 11-17 days) and 28 days (range: 25-31 days) after initiation of antimicrobial therapy.
Risk Factors for MBL-CRE Colonization and Infection
Identification of clinical, demographic, and treatment-related variables associated with perianal MBL-CRE colonization and subsequent infection.
Measured: From transplantation to 6 months post-transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324291
- Sponsor's protocol ID
- QTJC2024065
- Status last verified
- Nov 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT07324291
- Acronym / sponsor ID
- QTJC2024065
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Jan 2026 (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.
The goal of this observational study is to characterize the clinical features of metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) colonization and subsequent infection in patients after allogeneic hematopoietic stem cell transplantation (HSCT). The study aims to estimate the incidence of perianal MBL-CRE colonization, the proportion of subsequent infections, the associated risk factors, mortality, and the underlying antibiotic resistance mechanisms.
The main questions this study seeks to answer are:
- What is the incidence of perianal MBL-CRE colonization following allogeneic HSCT?
- Among colonized patients, what proportion subsequently develop MBL-CRE infections?
- What are the risk factors for colonization and infection, the patterns of antimicrobial resistance, and the mortality among infected patients? Participants will undergo perianal swab screening for CRE as part of their routine post-transplant care. MBL-CRE isolates identified from perianal swabs will undergo antimicrobial resistance genomic analysis to investigate bacterial transmission dynamics and resistance mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation;
Key exclusion criteria (1 listed)
- Engraftment failure.
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
Incidence of perianal MBL-CRE colonization.
Time frame: Within 100 days after allogeneic HSCT.
The proportion of patients who develop perianal colonization with metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) following allogeneic hematopoietic stem cell transplantation (HSCT).
6 secondary outcomes
Incidence of MBL-CRE Infection Among Colonized Patients.
Time frame: From the time of colonization to 6 months after HSCT.
Infection-Related Mortality.
Time frame: 28 days after documented onset of MBL-CRE infection.
All-Cause Mortality.
Time frame: 28 days after documented onset of MBL-CRE infection.
Clinical Cure Rate
Time frame: 28 days (range: 25-31 days) after initiation of antimicrobial therapy
Microbiological Eradication Rate.
Time frame: 14 days (range: 11-17 days) and 28 days (range: 25-31 days) after initiation of antimicrobial therapy.
Risk Factors for MBL-CRE Colonization and Infection
Time frame: From transplantation to 6 months post-transplant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION and Carbapenem-resistant Enterobacterales, run by Institute of Hematology & Blood Diseases Hospital, 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 1 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: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perianal MBL-CRE colonization. (time frame: Within 100 days after allogeneic HSCT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.