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

NCT ID: NCT03611257

Last Updated: 2019-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-10-10

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Hematologic Diseases Bacteremia Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single center prospective randomised clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dRAST

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

Group Type EXPERIMENTAL

dRAST

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Current standard method

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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dRAST

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

Intervention Type DIAGNOSTIC_TEST

Current standard method

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wan Beom Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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[email protected] Park, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 25520395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28442767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29415214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16625125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16859504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25261540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7714220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17689933 (View on PubMed)

Other Identifiers

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1806-173-955

Identifier Type: -

Identifier Source: org_study_id

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