Carbapenem-resistant EnterobacteralesNCT07047352
Prospective Study Evaluate the Timing of Empirical Treatment for Carbapenem-resistant Bacterials (CROEAT Study)
A study testing Empirical treatment in people with Carbapenem-resistant Enterobacterales and Neutropenia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
In this study, we will evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover carbapenem resistance gram negative bacteria (CRO) in patients with hematological malignancies colonized with CRO. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carbapenem-resistant Enterobacterales, Neutropenia, Hematological Malignancies
- What is being tested?
- Empirical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hematological malignancies receiving hospital treatment such as chemotherapy/immunotherapy/hematopoietic stem cell transplantation;
- Those with a recent history of CRO colonization or who have been screened for CRO once a week continuously since admission;
- Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
- Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate>20% among recently hospitalized patients);
- Presence of fever or other possible signs and symptoms of infection;
- Neutropenia(ANC<0.1×10^9/L)expected to last for ≥7 days,and having any of the following:
Show all 15Show fewer
- Gastrointestinal mucositis/peri-anal infection/intestinal obstruction;
- Shock or severe sepsis;
- Respiratory failure:deoxygenated PaO2<60 mmHg or requiring mechanical ventilation;
- Disseminated intravascular coagulation;
- Altered mental status or psychiatric abnormalities;
- Congestive heart failure requiring treatment;
- Arrhythmia requiring treatment;
- Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).
- The patient or their legal guardian has signed the informed consent form.
Who cannot join
- Pregnant or breastfeeding women;
- Individuals who are expected to die within 14 days of hospitalization or have an expected hospital stay of less than 7 days;
- Any conditions that the investigator believes may increase the risk to the patient;
- Severe psychological or psychiatric disorders with poor estimated compliance;
- The presence of any other conditions that the investigator deems unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ling Wang contact
China1 site
Rui Jin Hospital
Shanghai, Shanghai Municipality, 200025
Jiong HU, 86-13764313546, hj10709@rjh.com.cn
Ling wang
About this study
Official title: A Multi-center Single Arm Prospective Study in Patients of Hematological Malignancies Colonized With Carbapenem-resistant Bacterials to Evaluate the Timing of Empirical Antibiotic Treatment (CROEAT Study)
In this study, we will evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover carbapenem resistance gram negative bacteria (CRO) in patients with hematological malignancies colonized with CRO. Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
- Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate>20% among recently hospitalized patients);
- Presence of fever or other possible signs and symptoms of infection;
- Neutropenia(ANC<0.1×10^9/L)expected to last for ≥7 days,and having any of the following:
Read more
- Gastrointestinal mucositis/peri-anal infection/intestinal obstruction;
- Shock or severe sepsis;
- Respiratory failure:deoxygenated PaO2<60 mmHg or requiring mechanical ventilation;
- Disseminated intravascular coagulation;
- Altered mental status or psychiatric abnormalities;
- Congestive heart failure requiring treatment;
- Arrhythmia requiring treatment;
- Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).
The endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.
Read the detailed description
Neutropenic fever is common in patients with hematological malignancies undergoing chemotherapy or transplantation. Empirical antibiotics therapy is essential treatment principle. In China, recent evidence demonstrated that the carbapenem resistant gram negative bacteria was emerging as an important issue and CRO colonization was positive in about 10% of patients by rectal swab. In such group of patients, the empirical treatment of patients with neutropenic fever therapy remained as a challenge. In this study, we plan to evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover CRO in patients with hematological malignancies colonized with CRO.
Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
- Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate>20% among recently hospitalized patients);
- Presence of fever or other possible signs and symptoms of infection;
- Neutropenia(ANC<0.1×10^9/L)expected to last for ≥7 days,and having any of the following:
- Gastrointestinal mucositis/peri-anal infection/intestinal obstruction;
- Shock or severe sepsis;
- Respiratory failure:deoxygenated PaO2<60 mmHg or requiring mechanical ventilation;
- Disseminated intravascular coagulation;
- Altered mental status or psychiatric abnormalities;
- Congestive heart failure requiring treatment;
- Arrhythmia requiring treatment;
- Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).
The endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.
- Being tested
- Empirical treatment
- Keywords
- carbapenem-resistant enterobacterales, hematological malignancies, neutropenia, empirical therapy
- Medical subject headings
- Neutropenia, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empirical treatmentOther
Empirical treatment to cover carbapenem-resistant enterobacterales
| Study group | Role | What they receive |
|---|---|---|
| Study: empirical treatment | Experimental | Empirical treatment to cover carbapenem-resistant enterobacterales Receives: Other: Empirical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of overall mortality
Patients died of any causes
Measured: 14 days
Secondary outcomes (3)
Incidence of documented CRE blood stream infection
Patients with positive culture of carbapenem-resistant enterobacterales
Measured: 30 days
Clinical response
Patients with full recovery of clinical signs and symptoms of infection
Measured: 14 days
microbiology response
Patients with clearance of blood carbapenem-resistant enterobacterales
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-resistant EnterobacteralesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Empirical antibiotics treatment covering carbapenem-resistant enterobacterales (CRE) in neutropenic patients with positive CRE colonization after screening to meet the inclusion criteria.
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiong Hu, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047352
- Sponsor's protocol ID
- RJH-BMT-2403
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Single Arm Prospective Study in Patients of Hematological Malignancies Colonized With Carbapenem-resistant Bacterials to Evaluate the Timing of Empirical Antibiotic Treatment (CROEAT Study)
- ClinicalTrials.gov ID
- NCT07047352
- Acronym / sponsor ID
- RJH-BMT-2403
- Keywords
- carbapenem-resistant enterobacterales, hematological malignancies, neutropenia, empirical therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
In this study, we will evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover carbapenem resistance gram negative bacteria (CRO) in patients with hematological malignancies colonized with CRO. Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
- Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate>20% among recently hospitalized patients);
- Presence of fever or other possible signs and symptoms of infection;
- Neutropenia(ANC<0.1×10^9/L)expected to last for ≥7 days,and having any of the following:
- Gastrointestinal mucositis/peri-anal infection/intestinal obstruction;
- Shock or severe sepsis;
- Respiratory failure:deoxygenated PaO2<60 mmHg or requiring mechanical ventilation;
- Disseminated intravascular coagulation;
- Altered mental status or psychiatric abnormalities;
- Congestive heart failure requiring treatment;
- Arrhythmia requiring treatment;
- Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).
The endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.
Detailed description
Neutropenic fever is common in patients with hematological malignancies undergoing chemotherapy or transplantation. Empirical antibiotics therapy is essential treatment principle. In China, recent evidence demonstrated that the carbapenem resistant gram negative bacteria was emerging as an important issue and CRO colonization was positive in about 10% of patients by rectal swab. In such group of patients, the empirical treatment of patients with neutropenic fever therapy remained as a challenge. In this study, we plan to evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover CRO in patients with hematological malignancies colonized with CRO.
Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
- Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate>20% among recently hospitalized patients);
- Presence of fever or other possible signs and symptoms of infection;
- Neutropenia(ANC<0.1×10^9/L)expected to last for ≥7 days,and having any of the following:
- Gastrointestinal mucositis/peri-anal infection/intestinal obstruction;
- Shock or severe sepsis;
- Respiratory failure:deoxygenated PaO2<60 mmHg or requiring mechanical ventilation;
- Disseminated intravascular coagulation;
- Altered mental status or psychiatric abnormalities;
- Congestive heart failure requiring treatment;
- Arrhythmia requiring treatment;
- Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).
The endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Empirical antibiotics treatment covering carbapenem-resistant enterobacterales (CRE) in neutropenic patients with positive CRE colonization after screening to meet the inclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Study: empirical treatment | Experimental | Other: Empirical treatmentEmpirical treatment to cover carbapenem-resistant enterobacterales |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with hematological malignancies receiving hospital treatment such as chemotherapy/immunotherapy/hematopoietic stem cell transplantation;
- Those with a recent history of CRO colonization or who have been screened for CRO once a week continuously since admission;
- Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
- The patient or their legal guardian has signed the informed consent form.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women;
- Individuals who are expected to die within 14 days of hospitalization or have an expected hospital stay of less than 7 days;
- Any conditions that the investigator believes may increase the risk to the patient;
- Severe psychological or psychiatric disorders with poor estimated compliance;
- The presence of any other conditions that the investigator deems unsuitable for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empirical treatmentEmpirical treatment to cover carbapenem-resistant enterobacterales | Other | Study: empirical treatment |
Primary outcome
Incidence of overall mortality
Time frame: 14 days
Patients died of any causes
3 secondary outcomes
Incidence of documented CRE blood stream infection
Time frame: 30 days
Clinical response
Time frame: 14 days
microbiology response
Time frame: 14 days
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 2 Jul 2025.
- 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.
Ling Wang contact
Jiong Hu principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empirical treatment in people with Carbapenem-resistant Enterobacterales and Neutropenia, run by Shanghai Jiao Tong University School of Medicine 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 15 inclusion and 5 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 2 Jul 2025. 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?
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?
Contact jiong hu (86-13764313546, hj10709@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of overall mortality (time frame: 14 days). 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 2 Jul 2025.