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Hematologic DiseasesNCT03611257

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

A study testing dRAST and Current standard method in people with Hematologic Diseases and Bacteremia Sepsis, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Hematologic Diseases, Bacteremia Sepsis
What is being tested?
dRAST and Current standard method
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteSouth Korea
Study dates
1 Sep 2018to 10 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: Effect of Direct Rapid Antibiotic Susceptibility Testing (dRAST) on Treatment for Bacteremia in Patients With Hematologic Diseases: Randomized Controlled Trial

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.

Read the 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.
Being tested
dRAST, Current standard method
Keywords
Bacteremia, Optimal targeted antibiotics, Antibiotic susceptibility test, Antimicrobial stewardship
Medical subject headings
Hematologic Diseases, Bacteremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dRASTDiagnostic 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 methodDiagnostic test

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

Study groups in NCT03611257
Study groupRoleWhat they receive
dRASTExperimentalHematologic patients with bacteremia will receive antibiotics based on "dRAST" results.
Receives: Diagnostic Test: dRAST
Current standard methodActive comparatorHematologic patients with bacteremia will receive antibiotics based on current standard method results.
Receives: Diagnostic Test: Current standard method

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 72 hour after blood culture collection

Secondary outcomes (10)

  1. Time to optimal targeted antibiotics

    The time to the optimal targeted antibiotics administration after blood culture collection

    Measured: Time from first blood culture collection up to 1 month

  2. Amount of broad-spectrum antibiotics use

    The duration of use of major antibiotics (vancomycin, carbapenem)

    Measured: Time from first blood culture collection up to 1 week

  3. Time to defervescence

    Time from the time of blood culture collection to the time of fever resolution

    Measured: Time from first blood culture collection up to 1 month

  4. proportion of positive blood culture 48 hours after first blood culture

    proportion of positive blood culture 48 hours after first blood culture

    Measured: Time from blood culture collection up to 1 month

  5. 30-day mortality rate related with bacteremia

    30-day mortality rate related with bacteremia

    Measured: Time from blood culture collection up to 30-day

  6. 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

    Measured: 48 hour after blood culture collection

  7. 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

    Measured: 48 hour after blood culture collection

  8. 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

    Measured: 72 hour after blood culture collection

  9. 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

    Measured: 48 hour after blood culture collection

  10. 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

    Measured: 72 hour after blood culture collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2018
  2. Study start1 Sep 2018
  3. Primary completion15 Sep 2019
  4. Study completion10 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single center prospective randomised clinical trial
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03611257
Sponsor's protocol ID
1806-173-955
Status last verified
Oct 2019
First submitted
26 Jul 2018
Last updated
14 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 25520395

  • 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.

    PubMed 28442767

  • 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.

    PubMed 29415214

  • 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.

    PubMed 16625125

  • 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.

    PubMed 16859504

  • 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.

    PubMed 25261540

  • 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.

    PubMed 7714220

  • 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.

    PubMed 17689933

Questions about this trial

What is this clinical trial studying?

A study testing dRAST and Current standard method in people with Hematologic Diseases and Bacteremia Sepsis, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients receiving optimal targeted antibiotics 72 hours after blood collection for blood culture (time frame: 72 hour after blood culture collection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03611257, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.

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