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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Empirical treatment

    Other intervention

    Empirical treatment to cover carbapenem-resistant enterobacterales

Treatment groups

91 Participants
are divided into 1 treatment group
Group A: Study: empirical treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of overall mortality

Patients died of any causes

Time frame
14 days

Secondary outcomes

1

Incidence of documented CRE blood stream infection

Patients with positive culture of carbapenem-resistant enterobacterales

Time frame
30 days
2

Clinical response

Patients with full recovery of clinical signs and symptoms of infection

Time frame
14 days
3

microbiology response

Patients with clearance of blood carbapenem-resistant enterobacterales

Time frame
14 days

Other outcomes

Sponsors and contacts

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