Effect of dRAST on Treatment for Bacteremia in Patients With Hematologic Diseases
- Conditions
- Hematologic DiseasesBacteremia Sepsis
- Interventions
- Diagnostic Test: dRASTDiagnostic Test: Current standard method
- Registration Number
- NCT03611257
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dRAST dRAST Hematologic patients with bacteremia will receive antibiotics based on "dRAST" results. Current standard method Current standard method Hematologic patients with bacteremia will receive antibiotics based on current standard method results.
- Primary Outcome Measures
Name Time Method Percentage of patients receiving optimal targeted antibiotics 72 hours after blood collection for blood culture 72 hour after blood culture collection 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
- Secondary Outcome Measures
Name Time Method Amount of broad-spectrum antibiotics use Time from first blood culture collection up to 1 week The duration of use of major antibiotics (vancomycin, carbapenem)
Time to defervescence Time from first blood culture collection up to 1 month Time from the time of blood culture collection to the time of fever resolution
Time to optimal targeted antibiotics Time from first blood culture collection up to 1 month The time to the optimal targeted antibiotics administration after blood culture collection
Percentage of patients receiving unnecessary broad spectrum antibiotics 72 hours after 72 hour after blood culture collection 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
proportion of positive blood culture 48 hours after first blood culture Time from blood culture collection up to 1 month proportion of positive blood culture 48 hours after first blood culture
Percentage of patients receiving ineffective antibiotics 72 hours after 72 hour after blood culture collection The percentage of patients receiving ineffective antibiotics which is defined if the organisms were not susceptible, 72 hours after blood collection for blood culture
30-day mortality rate related with bacteremia Time from blood culture collection up to 30-day 30-day mortality rate related with bacteremia
Percentage of patients receiving optimal targeted antibiotics 48 hours after 48 hour after blood culture collection 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
Percentage of patients receiving unnecessary broad spectrum antibiotics 48 hours after 48 hour after blood culture collection 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
Percentage of patients receiving ineffective antibiotics 48 hours after 48 hour after blood culture collection The percentage of patients receiving ineffective antibiotics which is defined if the organisms were not susceptible, 48 hours after blood collection for blood culture
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of