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Trial record 56 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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

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ClinicalTrials.gov Identifier: NCT03611257
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Wan Beom Park, 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.

Condition or disease Intervention/treatment Phase
Hematologic Diseases Bacteremia Sepsis Diagnostic Test: dRAST Diagnostic Test: Current standard method Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center prospective randomised clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Direct Rapid Antibiotic Susceptibility Testing (dRAST) on Treatment for Bacteremia in Patients With Hematologic Diseases: Randomized Controlled Trial
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dRAST
Hematologic patients with bacteremia will receive antibiotics based on "dRAST" results.
Diagnostic Test: dRAST
Infectious diseases specialists will do active antimicrobial stewardship according to dRAST results in addition to Gram staining results and current standard method.

Active Comparator: Current standard method
Hematologic patients with bacteremia will receive antibiotics based on current standard method results.
Diagnostic Test: Current standard method
Infectious diseases specialists will do active antimicrobial stewardship according to Gram staining results, and current standard method without dRAST results.




Primary Outcome Measures :
  1. Percentage of patients receiving optimal targeted antibiotics 72 hours after blood collection for blood culture [ Time Frame: 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 :
  1. Time to optimal targeted antibiotics [ Time Frame: Time from first blood culture collection up to 1 month ]
    The time to the optimal targeted antibiotics administration after blood culture collection

  2. Amount of broad-spectrum antibiotics use [ Time Frame: Time from first blood culture collection up to 1 week ]
    The duration of use of major antibiotics (vancomycin, carbapenem)

  3. Time to defervescence [ Time Frame: Time from first blood culture collection up to 1 month ]
    Time from the time of blood culture collection to the time of fever resolution

  4. proportion of positive blood culture 48 hours after first blood culture [ Time Frame: Time from blood culture collection up to 1 month ]
    proportion of positive blood culture 48 hours after first blood culture

  5. 30-day mortality rate related with bacteremia [ Time Frame: Time from blood culture collection up to 30-day ]
    30-day mortality rate related with bacteremia

  6. Percentage of patients receiving optimal targeted antibiotics 48 hours after [ Time Frame: 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

  7. Percentage of patients receiving unnecessary broad spectrum antibiotics 48 hours after [ Time Frame: 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

  8. Percentage of patients receiving unnecessary broad spectrum antibiotics 72 hours after [ Time Frame: 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

  9. Percentage of patients receiving ineffective antibiotics 48 hours after [ Time Frame: 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

  10. Percentage of patients receiving ineffective antibiotics 72 hours after [ Time Frame: 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



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611257


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: wbpark1@snu.ac.kr Park, M.D., PhD. Seoul National University Hospital

Publications:

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Responsible Party: Wan Beom Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03611257     History of Changes
Other Study ID Numbers: 1806-173-955
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wan Beom Park, Seoul National University Hospital:
Bacteremia
Optimal targeted antibiotics
Antibiotic susceptibility test
Antimicrobial stewardship
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Bacteremia
Hematologic Diseases
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes