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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Empirical treatment
Other interventionEmpirical treatment to cover carbapenem-resistant enterobacterales
Treatment groups
Trial outcomes
Primary outcomes
Incidence of overall mortality
Patients died of any causes
Secondary outcomes
Incidence of documented CRE blood stream infection
Patients with positive culture of carbapenem-resistant enterobacterales
Clinical response
Patients with full recovery of clinical signs and symptoms of infection
microbiology response
Patients with clearance of blood carbapenem-resistant enterobacterales
Sponsors and contacts
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