Clinical trial NCT03611257: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Diseases
Bacteremia Sepsis
Keywords: Bacteremia
Optimal targeted antibiotics
Antibiotic susceptibility test
Antimicrobial stewardship
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 116
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center prospective randomised clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of patients receiving optimal targeted antibiotics 72 hours after blood collection for blood culture
timeFrame: 72 hour after blood culture collection
Secondary outcomes:
measure: Time to optimal targeted antibiotics
timeFrame: Time from first blood culture collection up to 1 month
measure: Amount of broad-spectrum antibiotics use
timeFrame: Time from first blood culture collection up to 1 week
measure: Time to defervescence
timeFrame: Time from first blood culture collection up to 1 month
measure: proportion of positive blood culture 48 hours after first blood culture
timeFrame: Time from blood culture collection up to 1 month
measure: 30-day mortality rate related with bacteremia
timeFrame: Time from blood culture collection up to 30-day
measure: Percentage of patients receiving optimal targeted antibiotics 48 hours after
timeFrame: 48 hour after blood culture collection
measure: Percentage of patients receiving unnecessary broad spectrum antibiotics 48 hours after
timeFrame: 48 hour after blood culture collection
measure: Percentage of patients receiving unnecessary broad spectrum antibiotics 72 hours after
timeFrame: 72 hour after blood culture collection
measure: Percentage of patients receiving ineffective antibiotics 48 hours after
timeFrame: 48 hour after blood culture collection
measure: Percentage of patients receiving ineffective antibiotics 72 hours after
timeFrame: 72 hour after blood culture collection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: wbpark1@snu.ac.kr Park, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Huh HJ, Song DJ, Shim HJ, Kwon WK, Park MS, Ryu MR, Cho EH, Oh J, Yoo IY, Lee NY. Performance evaluation of the QMAC-dRAST for staphylococci and enterococci isolated from blood culture: a comparative study of performance with the VITEK-2 system. J Antimicrob Chemother. 2018 May 1;73(5):1267-1271. doi: 10.1093/jac/dky015.
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citation: Garnacho-Montero J, Aldabo-Pallas T, Garnacho-Montero C, Cayuela A, Jimenez R, Barroso S, Ortiz-Leyba C. Timing of adequate antibiotic therapy is a greater determinant of outcome than are TNF and IL-10 polymorphisms in patients with sepsis. Crit Care. 2006;10(4):R111. doi: 10.1186/cc4995.
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.
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