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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;
The endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.
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;
The endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study: empirical treatment | Experimental | Empirical treatment to cover carbapenem-resistant enterobacterales |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empirical treatment | Other | Empirical treatment to cover carbapenem-resistant enterobacterales |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of overall mortality | Patients died of any causes | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of documented CRE blood stream infection | Patients with positive culture of carbapenem-resistant enterobacterales | 30 days |
| Clinical response | Patients with full recovery of clinical signs and symptoms of infection |
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Inclusion Criteria:
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;
The patient or their legal guardian has signed the informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jiong hu | Contact | 86-13764313546 | hj10709@rjh.com.cn | |
| Ling Wang | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Jiong Hu | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rui Jin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
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Empirical antibiotics treatment covering carbapenem-resistant enterobacterales (CRE) in neutropenic patients with positive CRE colonization after screening to meet the inclusion criteria.
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| 14 days |
| microbiology response | Patients with clearance of blood carbapenem-resistant enterobacterales | 14 days |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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