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

NCT03611257 | Completed DMC

• 1 other identifier: 1806-173-955
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Diseases; Bacteremia Sepsis

Keywords

Bacteremia; Optimal targeted antibiotics; Antibiotic susceptibility test; Antimicrobial stewardship

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Time to optimal targeted antibiotics

  Time from first blood culture collection up to 1 month

• Amount of broad-spectrum antibiotics use

  Time from first blood culture collection up to 1 week

• Time to defervescence

  Time from first blood culture collection up to 1 month

• 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

  Time from blood culture collection up to 30-day

Study Arms (2)

dRAST

EXPERIMENTAL

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

Diagnostic Test: dRAST

Current standard method

ACTIVE COMPARATOR

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

Diagnostic Test: Current standard method

Interventions

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.

dRAST

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.

Current standard method

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (8)

• 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.

  PMID: 25520395 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.

  PMID: 28442767 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.

  PMID: 29415214 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.

  PMID: 16625125 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.

  PMID: 16859504 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.

  PMID: 25261540 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.

  PMID: 7714220 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.

  PMID: 17689933 BACKGROUND

MeSH Terms

Conditions

Hematologic Diseases; Bacteremia

Condition Hierarchy (Ancestors)

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

Study Officials

• wbpark1@snu.ac.kr Park, M.D., PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single center prospective randomised clinical trial

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: September 1, 2018
• Primary Completion: September 15, 2019
• Study Completion: October 10, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)