An interventional study of Filmarray Blood Culture ID (BCID) panel and Rosco Diagnostica ESBL/carbapenemase screen kit in Bacteremia, Sepsis and Fungemia, sponsored by Tan Tock Seng Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 103 Years. Per ClinicalTrials.gov, last updated 2019-09-10.
Sponsored by Tan Tock Seng Hospital · Not applicable, Interventional, and Diagnostic
Septic shock carries high mortality, which may be exacerbated by inappropriate initial therapy. Inappropriate therapy may result from unanticipated antimicrobial resistance. Conversely, positive blood cultures may result from contamination, leading to unnecessary therapy and procedures and possibly prolonged hospitalization. Clinicians may also resort to broad spectrum antimicrobials and be hesitant to de-escalate while awaiting susceptibility results.
The investigators hypothesize that rapid identification of pathogens and antimicrobial resistance will ameliorate the above problems and improve time to optimal therapy, avoid unnecessary therapy and ultimately improve patient outcomes. While there are a number of in-vitro and uncontrolled clinical studies, there is a paucity of well-designed clinical trials objectively examining the real-world clinical and health-economic impact of such technology. To date only one randomised trial has been performed in the US (ClinicalTrials.gov NCT01898208), at a setting with low endemic rates of antimicrobial resistance. This is a companion study to NCT01898208. The investigators aim to study the clinical impact and cost-effectiveness of a strategy for rapid pathogen and resistance detection in a setting with a moderate to high levels of antimicrobial resistance.
Hypothesis:
Devices to be studied for this proposed study:
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's planned enrollment of 832 is above the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →Tan Tock Seng Hospital is the lead sponsor of 108 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Tan Tock Seng Hospital (TTSH) practices (bacterial culture and susceptibility testing) AND FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen will be performed. The Interventions to be administered are the rapid diagnostic tests: FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen. Subjects will be recruited 8am-3pm daily, weekdays only. Results of the BCID and Rosco test will be communicated to the managing physicians by phone in real-time.
Device: Filmarray Blood Culture ID (BCID) panel · Device: Rosco Diagnostica ESBL/carbapenemase screen kit
Standard Tan Tock Seng Hospital (TTSH) practices (bacterial culture and susceptibility testing) will be used. FilmArray BCID and Rosco Diagnostica ESBL and carbapenemase screen will NOT be performed. Subjects will be recruited 8am-3pm daily, weekdays only.
The BCID panel is an FDA-approved nucleic acid amplification test (based on nested polymerase chain reaction) which detects Gram positive, Gram negative, the major Candida species and antimicrobial resistance markers (mecA for methicillin resistance, van A/B for vancomycin resistance, blaKPC for KPC carbapenemase) directly from positive blood cultures in \< 1 - 1.5 hours
Also known as: BCID
These kits are CE-marked (Approved in the European Union) rapid chromogenic tests for extended-spectrum beta-lactamase / carbapenemase detection from both blood cultures and cultured bacterial colonies.
Time from positive blood culture result to effective/optimal antibiotics
An effective antibiotic is defined as an antibiotic regimen to which the bacterial/fungal isolate is susceptible (or predicted to be susceptible for Candida, per speciation).An optimal antibiotic is defined as an antibiotic regimen to which the bacterial/fungal isolate is susceptible/predicted to be susceptible, which is the most narrow spectrum and targeted, as recommended by institutional guidelines. This will be considered as the time from the positive Gram stain to first effective and the first optimal antibiotic.
Time frame: Approximately 14 days after positive blood culture
Clinical outcome (Infection related mortality)
Infection-related at 30-day, 90-days and 1-year
Time frame: 1 year
Clinical outcome (All-cause related mortality)
All cause mortality at 30-day, 90-days and 1-year mortality
Time frame: 1 year
Clinical outcome (Quality of life)
Quality of life at enrolment, 90-days and at 1 year, as measured by the tools EQ-5D-5L QoL/SF-12
Time frame: 1 year
Time from positive blood culture result to bacterial identification
Time frame: Approximately 3 days
Duration of hospitalization (days)
Time frame: Participants were followed for the duration of hospital stay, approximately 28 days
Duration of bacteremia/fungemia (days)
Time frame: Patient-dependent variable, estimated up to 7 days
Time to isolation precautions
Time taken for implementation of appropriate infection control measures (isolation precautions) as appropriate for pathogen detected
Time frame: Estimated up to 5 days
Antibiotic-associated adverse events
This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.
Time frame: Approximately 14 days after positive blood culture
Antimicrobial utilization (hours/days of therapy)
Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.
Time frame: Approximately 4 days after enrollment
Mean Total Hospitalization Costs Per Subject
These will be calculated based on actual billable patient costs (without government subventions/subsidies) following 7 days after the positive blood culture episode and for the duration of hospitalization, up to an estimated 24 weeks.
Time frame: Approximately 7 days after positive blood culture for up to an estimated 24 weeks
Mean Laboratory Costs Per Subject
These will be calculated based on actual billable laboratory costs (without government subventions/subsidies) following 7 days after the positive blood culture episode and for the duration of hospitalization, up to an estimated 24 weeks.
Time frame: Approximately 7 days after positive blood culture for up to an estimated 24 week
Mean Antimicrobials Costs Per Subject
These will be calculated based on actual billable antimicrobial costs (without government subventions/subsidies) following 7 days after the positive blood culture episode and for the duration of hospitalization, up to an estimated 24 weeks.
Time frame: Approximately 7 days after positive blood culture and for duration of entire hospitalization
Cost-effectiveness analysis
Incremental cost-effectiveness ratios will be determined by dividing the difference between the average costs of treating a patient in the after phase (C1) and the average cost in the before phase (C0) by the difference between average health outcomes (QALYs) gained in the after phase (O1) and those gained in the before phase (O0). The incremental cost-effectiveness ratio is calculated by the following equation: (C1 - C0)/(O1 - O0). Incremental cost-effectiveness ratios using quality adjusted/sepsis adjusted life years gained as the health outcome of interest will then be determined, based on the method of Jones et al Crit Care Med. 2011 June ; 39(6): 1306-1312.
Time frame: Up to 1 year after enrolment and using a 'modeled horizon' based on sepsis-adjusted life expectancies
Time on effective/optimal antibiotics within first 96 hours of positive blood culture
An effective antibiotic is defined as an antibiotic regimen to which the bacterial/fungal isolate is susceptible (or predicted to be susceptible for Candida, per speciation).An optimal antibiotic is defined as an antibiotic regimen to which the bacterial/fungal isolate is susceptible/predicted to be susceptible, which is the most narrow spectrum and targeted, as recommended by institutional guidelines. This will be considered in the 96-hour time frame from the positive Gram stain.
Time frame: First 96 hours after blood culture turns positive
Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics
De-escalation included discontinuation of 1 or more antibiotics and/or switching from a broad- to a narrow spectrum antibiotic. Escalation included initiation of 1 or more antibiotics and/or switching from a narrow- to a broad-spectrum antibiotic
Time frame: Positive Gram stain, 96 hours after enrollment
Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours
Contaminated blood cultures were defined as growth of organisms such as coagulase-negative staphylococci from a single blood culture set when greater than or equal to 2 blood culture sets were collected, except among subjects suspected to have true bacteremia associated with central venous catheters or devices.
Time frame: Within 24 hours after positive blood culture
Length of Entire Hospitalization (Days)
Time frame: Participants are followed for the duration of hospital stay, approximately 15 days
Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment
Time frame: Approximately within 72 hours of positive blood culture
Length of Intensive Care Unit Stay (days)
Time frame: Within 14 days of positive blood culture until ICU discharge, up to an estimated 24 weeks.
Percentage of Patients Who Acquired Clostridium Difficile Within 30 Days After Enrollment
Time frame: Approximately 30 days after positive blood culture
Percentage of Patients Who Acquired Multidrug-resistant organisms Within 30 Days After Enrollment
Multidrug-resistant organisms included vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, extended-spectrum cephalosporin-resistant Enterobacteriaceae, and Pseudomonas aeruginosa and Acinetobacter species resistant to greater than or equal to 3 antibiotic classes.
Time frame: Approximately 30 days after positive blood culture
Plan to share: No
Ran from Mar 2017 to primary completion in Jul 2019, 27 months.
Of 34 non-industry interventional studies with no phase under Bacteremia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 64. This study's 27 months is below that.
Counting every sponsor, half of 35 studies reached it within 34 months; a quarter within 13 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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