Effect of dRAST on Treatment for Bacteremia in Patients With Hematologic Diseases

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether the use of direct rapid antibiotic susceptibility test (dRAST), in addition to the current standard antibiotic susceptibility test, can increase the proportion of patients with hematologic disease who received appropriate antibiotics in early period of bacteremia.

Detailed Description
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patients with hematologic diseases who have high risk of bacteremia, because of immune suppression treatment or intensive chemotherapy or bone marrow transplantation which these patients had received, will be recruited in tertiary referral medical centers. All the participants will be randomly assigned into either dRAST group or current standard antibiotic susceptibility test group. All the participants in the both arms will receive antimicrobial stewardship by infectious disease specialists. Antimicrobial stewardship will be performed at each timepoint of Gram stain results reporting, dRAST results reporting, and current method reporting. Target numbers are 58 and 58, respectively. All the participants will be monitored for general medical conditions such as vital sign and response to antibiotic treatment by infectious disease specialists for 1 week. The percentage of patients who received optimal targeted antibiotics 72 hours after blood collection for blood culture will be evaluated.

Official Title
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Effect of Direct Rapid Antibiotic Susceptibility Testing (dRAST) on Treatment for Bacteremia in Patients With Hematologic Diseases: Randomized Controlled Trial

Conditions
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Hematologic Diseases, Bacteremia Sepsis

Intervention / Treatment
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* Diagnostic Test: dRAST
* Diagnostic Test: Current standard method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are expected to be admitted for more than 2 days due to treatment or complications of hematologic diseases (acute leukemia, chronic leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, aplastic anemia, etc.) in Seoul National University Hospital. Patients with confirmed bacteremia Patients who can understand the details of the clinical trial's explanation and provide the written consent Exclusion Criteria: Patients who are expected to stay in the hospital within 2 days Patients without bacteremia during hospitalization Patients who show fungemia without evidence of bacteremia

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center prospective randomised clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dRAST<br>Hematologic patients with bacteremia will receive antibiotics based on dRAST results. | Diagnostic Test: dRAST<br>* Infectious diseases specialists will do active antimicrobial stewardship according to dRAST results in addition to Gram staining results and current standard method.<br>|
| Active Comparator: Current standard method<br>Hematologic patients with bacteremia will receive antibiotics based on current standard method results. | Diagnostic Test: Current standard method<br>* Infectious diseases specialists will do active antimicrobial stewardship according to Gram staining results, and current standard method without dRAST results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients receiving optimal targeted antibiotics 72 hours after blood collection for blood culture | The percentage of patients receiving optimal targeted antibiotics antibiotics which is defined as most effective and narrowest antibiotics based on susceptibility testing results, 72 hours after blood collection for blood culture | 72 hour after blood culture collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to optimal targeted antibiotics | The time to the optimal targeted antibiotics administration after blood culture collection | Time from first blood culture collection up to 1 month | 
| Amount of broad-spectrum antibiotics use | The duration of use of major antibiotics (vancomycin, carbapenem) | Time from first blood culture collection up to 1 week | 
| Time to defervescence | Time from the time of blood culture collection to the time of fever resolution | Time from first blood culture collection up to 1 month | 
| proportion of positive blood culture 48 hours after first blood culture | proportion of positive blood culture 48 hours after first blood culture | Time from blood culture collection up to 1 month | 
| 30-day mortality rate related with bacteremia | 30-day mortality rate related with bacteremia | Time from blood culture collection up to 30-day | 
| Percentage of patients receiving optimal targeted antibiotics 48 hours after | The percentage of patients receiving optimal targeted antibiotics antibiotics which is defined as most effective and narrowest antibiotics based on susceptibility testing results, 48 hours after blood collection for blood culture | 48 hour after blood culture collection | 
| Percentage of patients receiving unnecessary broad spectrum antibiotics 48 hours after | The percentage of patients receiving unnecessary broad spectrum antibiotics which is defined as administration of antibiotics to which organisms were susceptible, but had broad-spectrum activity requiring de-escalation or discontinuing administration, 48 hours after blood collection for blood culture | 48 hour after blood culture collection | 
| Percentage of patients receiving unnecessary broad spectrum antibiotics 72 hours after | The percentage of patients receiving unnecessary broad spectrum antibiotics which is defined as administration of antibiotics to which organisms were susceptible, but had broad-spectrum activity requiring de-escalation or discontinuing administration, 72 hours after blood collection for blood culture | 72 hour after blood culture collection | 
| Percentage of patients receiving ineffective antibiotics 48 hours after | The percentage of patients receiving ineffective antibiotics which is defined if the organisms were not susceptible, 48 hours after blood collection for blood culture | 48 hour after blood culture collection | 
| Percentage of patients receiving ineffective antibiotics 72 hours after | The percentage of patients receiving ineffective antibiotics which is defined if the organisms were not susceptible, 72 hours after blood collection for blood culture | 72 hour after blood culture collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacteremia, Optimal targeted antibiotics, Antibiotic susceptibility test, Antimicrobial stewardship