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

Primary Purpose

Hematologic Diseases, Bacteremia Sepsis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dRAST
Current standard method
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Diseases focused on measuring Bacteremia, Optimal targeted antibiotics, Antibiotic susceptibility test, Antimicrobial stewardship

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dRAST

Current standard method

Arm Description

Hematologic patients with bacteremia will receive antibiotics based on "dRAST" results.

Hematologic patients with bacteremia will receive antibiotics based on current standard method results.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to optimal targeted antibiotics
The time to the optimal targeted antibiotics administration after blood culture collection
Amount of broad-spectrum antibiotics use
The duration of use of major antibiotics (vancomycin, carbapenem)
Time to defervescence
Time from the time of blood culture collection to the time of fever resolution
proportion of positive blood culture 48 hours after first blood culture
proportion of positive blood culture 48 hours after first blood culture
30-day mortality rate related with bacteremia
30-day mortality rate related with bacteremia
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
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
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
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
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

Full Information

First Posted
July 26, 2018
Last Updated
October 11, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03611257
Brief Title
Effect of dRAST on Treatment for Bacteremia in Patients With Hematologic Diseases
Official Title
Effect of Direct Rapid Antibiotic Susceptibility Testing (dRAST) on Treatment for Bacteremia in Patients With Hematologic Diseases: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases, Bacteremia Sepsis
Keywords
Bacteremia, Optimal targeted antibiotics, Antibiotic susceptibility test, Antimicrobial stewardship

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center prospective randomised clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dRAST
Arm Type
Experimental
Arm Description
Hematologic patients with bacteremia will receive antibiotics based on "dRAST" results.
Arm Title
Current standard method
Arm Type
Active Comparator
Arm Description
Hematologic patients with bacteremia will receive antibiotics based on current standard method results.
Intervention Type
Diagnostic Test
Intervention Name(s)
dRAST
Intervention Description
Infectious diseases specialists will do active antimicrobial stewardship according to dRAST results in addition to Gram staining results and current standard method.
Intervention Type
Diagnostic Test
Intervention Name(s)
Current standard method
Intervention Description
Infectious diseases specialists will do active antimicrobial stewardship according to Gram staining results, and current standard method without dRAST results.
Primary Outcome Measure Information:
Title
Percentage of patients receiving optimal targeted antibiotics 72 hours after blood collection for blood culture
Description
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
Time Frame
72 hour after blood culture collection
Secondary Outcome Measure Information:
Title
Time to optimal targeted antibiotics
Description
The time to the optimal targeted antibiotics administration after blood culture collection
Time Frame
Time from first blood culture collection up to 1 month
Title
Amount of broad-spectrum antibiotics use
Description
The duration of use of major antibiotics (vancomycin, carbapenem)
Time Frame
Time from first blood culture collection up to 1 week
Title
Time to defervescence
Description
Time from the time of blood culture collection to the time of fever resolution
Time Frame
Time from first blood culture collection up to 1 month
Title
proportion of positive blood culture 48 hours after first blood culture
Description
proportion of positive blood culture 48 hours after first blood culture
Time Frame
Time from blood culture collection up to 1 month
Title
30-day mortality rate related with bacteremia
Description
30-day mortality rate related with bacteremia
Time Frame
Time from blood culture collection up to 30-day
Title
Percentage of patients receiving optimal targeted antibiotics 48 hours after
Description
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
Time Frame
48 hour after blood culture collection
Title
Percentage of patients receiving unnecessary broad spectrum antibiotics 48 hours after
Description
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
Time Frame
48 hour after blood culture collection
Title
Percentage of patients receiving unnecessary broad spectrum antibiotics 72 hours after
Description
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
Time Frame
72 hour after blood culture collection
Title
Percentage of patients receiving ineffective antibiotics 48 hours after
Description
The percentage of patients receiving ineffective antibiotics which is defined if the organisms were not susceptible, 48 hours after blood collection for blood culture
Time Frame
48 hour after blood culture collection
Title
Percentage of patients receiving ineffective antibiotics 72 hours after
Description
The percentage of patients receiving ineffective antibiotics which is defined if the organisms were not susceptible, 72 hours after blood collection for blood culture
Time Frame
72 hour after blood culture collection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wbpark1@snu.ac.kr Park, M.D., PhD.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to share IPDs publically, but de-identified individual participant data for all outcome measures could be shared with other researchers under their request.
Citations:
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25520395
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
Bauer KA, Perez KK, Forrest GN, Goff DA. Review of rapid diagnostic tests used by antimicrobial stewardship programs. Clin Infect Dis. 2014 Oct 15;59 Suppl 3:S134-45. doi: 10.1093/cid/ciu547.
Results Reference
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Effect of dRAST on Treatment for Bacteremia in Patients With Hematologic Diseases

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