Prospective Study Evaluate the Timing of Empirical Treatment for Carbapenem-resistant Bacterials (CROEAT Study)

NCT07047352 | Not Yet Recruiting

• 1 other identifier: RJH-BMT-2403
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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. Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:

• 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.

Conditions

Carbapenem-resistant Enterobacterales; Neutropenia; Hematological Malignancies

Keywords

carbapenem-resistant enterobacterales; hematological malignancies; neutropenia; empirical therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of overall mortality

  Patients died of any causes

  14 days

Secondary Outcomes (3)

• Incidence of documented CRE blood stream infection

  30 days

• Clinical response

  14 days

• microbiology response

  14 days

Study Arms (1)

Study: empirical treatment

EXPERIMENTAL

Empirical treatment to cover carbapenem-resistant enterobacterales

Other: Empirical treatment

Interventions

Empirical treatment OTHER

Empirical treatment to cover carbapenem-resistant enterobacterales

Study: empirical treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Rui Jin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Neutropenia; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms

Study Officials

• Jiong Hu

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jiong hu

CONTACT

86-13764313546; hj10709@rjh.com.cn

Ling Wang

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Empirical antibiotics treatment covering carbapenem-resistant enterobacterales (CRE) in neutropenic patients with positive CRE colonization after screening to meet the inclusion criteria.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: August 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)