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.
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.
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.
- Conditions
- Hematologic Diseases, Bacteremia Sepsis
- 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 group | Role | What they receive |
|---|---|---|
| dRAST | Experimental | Hematologic patients with bacteremia will receive antibiotics based on "dRAST" results. Receives: Diagnostic Test: dRAST |
| Current standard method | Active comparator | Hematologic 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.
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)
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
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
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
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
30-day mortality rate related with bacteremia
30-day mortality rate related with bacteremia
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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.
- First posted2 Aug 2018
- Study start1 Sep 2018
- Primary completion15 Sep 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Beom Park, Seoul National University Hospital
- Investigators
- wbpark1@snu.ac.kr Park, M.D., PhD., Principal investigator, Seoul National University Hospital
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 25520395Choi 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 28442767Huh 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 29415214Kumar 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 16625125Garnacho-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 16859504Bauer 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 25261540Renders 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 7714220Klastersky 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Direct Rapid Antibiotic Susceptibility Testing (dRAST) on Treatment for Bacteremia in Patients With Hematologic Diseases: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03611257
- Acronym / sponsor ID
- 1806-173-955
- Conditions
- Hematologic Diseases, Bacteremia Sepsis
- Keywords
- Bacteremia, Optimal targeted antibiotics, Antibiotic susceptibility test, Antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center prospective randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| dRAST | Experimental | Diagnostic Test: dRASTHematologic patients with bacteremia will receive antibiotics based on "dRAST" results. |
| Current standard method | Active comparator | Diagnostic Test: Current standard methodHematologic patients with bacteremia will receive antibiotics based on current standard method results. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dRASTInfectious diseases specialists will do active antimicrobial stewardship according to dRAST results in addition to Gram staining results and current standard method. | Diagnostic test | dRAST |
| Current standard methodInfectious diseases specialists will do active antimicrobial stewardship according to Gram staining results, and current standard method without dRAST results. | Diagnostic test | Current standard method |
Primary outcome
Percentage of patients receiving optimal targeted antibiotics 72 hours after blood collection for blood culture
Time frame: 72 hour after blood culture collection
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
10 secondary outcomes
Time to optimal targeted antibiotics
Time frame: Time from first blood culture collection up to 1 month
Amount of broad-spectrum antibiotics use
Time frame: Time from first blood culture collection up to 1 week
Time to defervescence
Time frame: Time from first blood culture collection up to 1 month
proportion of positive blood culture 48 hours after first blood culture
Time frame: Time from blood culture collection up to 1 month
30-day mortality rate related with bacteremia
Time frame: Time from blood culture collection up to 30-day
Percentage of patients receiving optimal targeted antibiotics 48 hours after
Time frame: 48 hour after blood culture collection
Percentage of patients receiving unnecessary broad spectrum antibiotics 48 hours after
Time frame: 48 hour after blood culture collection
Percentage of patients receiving unnecessary broad spectrum antibiotics 72 hours after
Time frame: 72 hour after blood culture collection
Percentage of patients receiving ineffective antibiotics 48 hours after
Time frame: 48 hour after blood culture collection
Percentage of patients receiving ineffective antibiotics 72 hours after
Time frame: 72 hour after blood culture collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Background: PubMed 25520395Choi 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.
- Background: PubMed 28442767Choi 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.
- Background: PubMed 29415214Huh 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.
- Background: PubMed 16625125Kumar 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.
- Background: PubMed 16859504Garnacho-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.
- Background: PubMed 25261540Bauer 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.
- Background: PubMed 7714220Renders 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.
- Background: PubMed 17689933Klastersky 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wbpark1@snu.ac.kr Park, M.D., PhD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
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.