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Completed

NCT Number: NCT03611257

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

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.

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Key information

Conditions

Hematologic Diseases Bacteremia Bacteremia Sepsis Bacterial Infections Bacterial Infections and Mycoses Hemic and Lymphatic Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dRAST

Diagnostic Test

Infectious diseases specialists will do active antimicrobial stewardship according to dRAST results in addition to Gram staining results and current standard method.

Current standard method

Diagnostic Test

Infectious diseases specialists will do active antimicrobial stewardship according to Gram staining results, and current standard method without dRAST results.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2018
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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