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

NCT07047352 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-07-02

No results posted yet for this study

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:

1. Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate\>20% among recently hospitalized patients);
2. Presence of fever or other possible signs and symptoms of infection;
3. 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.

Conditions

Interventions

OTHER

Empirical treatment

Empirical treatment to cover carbapenem-resistant enterobacterales

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jiong Hu · Ruijin Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07047352 on ClinicalTrials.gov