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

Seoul National University

Status: Completed

Conditions: Bacteremia Sepsis; Hematologic Diseases

Treatments: Diagnostic Test: dRAST; Diagnostic Test: Current standard method

Study type: Interventional

Funder types: Other

Identifiers

NCT03611257

1806-173-955

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

dRAST

Experimental group

Description:

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

Treatment:

Diagnostic Test: dRAST

Current standard method

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Current standard method