Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-02-12 @ 7:38 AM
Study NCT ID:
NCT03611257
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of dRAST on Treatment for Bacteremia in Patients With Hematologic Diseases
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Effect of Direct Rapid Antibiotic Susceptibility Testing (dRAST) on Treatment for Bacteremia in Patients With Hematologic Diseases: Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: