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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dRAST | Experimental | Hematologic patients with bacteremia will receive antibiotics based on "dRAST" results. |
|
| Current standard method | Active Comparator | Hematologic patients with bacteremia will receive antibiotics based on current standard method results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 72 hour after blood culture collection |
| Measure | Description | Time Frame |
|---|---|---|
| Time to optimal targeted antibiotics | The time to the optimal targeted antibiotics administration after blood culture collection | Time from first blood culture collection up to 1 month |
| Amount of broad-spectrum antibiotics use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| wbpark1@snu.ac.kr Park, M.D., PhD. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25520395 | Background | Choi J, Yoo J, Lee M, Kim EG, Lee JS, Lee S, Joo S, Song SH, Kim EC, Lee JC, Kim HC, Jung YG, Kwon S. A rapid antimicrobial susceptibility test based on single-cell morphological analysis. Sci Transl Med. 2014 Dec 17;6(267):267ra174. doi: 10.1126/scitranslmed.3009650. | |
| 28442767 | Background | Choi J, Jeong HY, Lee GY, Han S, Han S, Jin B, Lim T, Kim S, Kim DY, Kim HC, Kim EC, Song SH, Kim TS, Kwon S. Direct, rapid antimicrobial susceptibility test from positive blood cultures based on microscopic imaging analysis. Sci Rep. 2017 Apr 25;7(1):1148. doi: 10.1038/s41598-017-01278-2. |
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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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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Single center prospective randomised clinical trial
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| 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. |
|
The duration of use of major antibiotics (vancomycin, carbapenem)
| Time from first blood culture collection up to 1 week |
| Time to defervescence | Time from the time of blood culture collection to the time of fever resolution | Time from first blood culture collection up to 1 month |
| proportion of positive blood culture 48 hours after first blood culture | proportion of positive blood culture 48 hours after first blood culture | Time from blood culture collection up to 1 month |
| 30-day mortality rate related with bacteremia | 30-day mortality rate related with bacteremia | Time from blood culture collection up to 30-day |
| 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 | 48 hour after blood culture collection |
| 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 | 48 hour after blood culture collection |
| 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 | 72 hour after blood culture collection |
| 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 | 48 hour after blood culture collection |
| 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 | 72 hour after blood culture collection |
| 29415214 | Background | 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. |
| 16625125 | Background | Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96. doi: 10.1097/01.CCM.0000217961.75225.E9. |
| 16859504 | Background | 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. |
| 25261540 | Background | 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. |
| 7714220 | Background | Renders NH, Kluytmans JA, Verbrugh HA. Clinical impact of rapid in vitro susceptibility testing and bacterial identification. J Clin Microbiol. 1995 Feb;33(2):508. doi: 10.1128/jcm.33.2.508-508.1995. No abstract available. |
| 17689933 | Background | Klastersky J, Ameye L, Maertens J, Georgala A, Muanza F, Aoun M, Ferrant A, Rapoport B, Rolston K, Paesmans M. Bacteraemia in febrile neutropenic cancer patients. Int J Antimicrob Agents. 2007 Nov;30 Suppl 1:S51-9. doi: 10.1016/j.ijantimicag.2007.06.012. Epub 2007 Aug 8. |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |