Bacteremia SepsisHEMOFASTNCT03876990
Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia and Fungemia.
A study testing Multiplex PCR and Current strategy alone in people with Bacteremia Sepsis and Fungemia, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This study evaluates the clinical benefit of a rapid test for fast diagnosis of bacteremia and fungemia from positive blood cultures in case of sepsis. This assay enables rapid identification of bacteria and fungi and allows to evaluate bacterial resistance to first line antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia Sepsis, Fungemia
- What is being tested?
- Multiplex PCR and Current strategy alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2019to 19 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with bacteremia and/or fungemia defined by :
- 1/ the presence of clinical signs of sepsis; AND 2/ a positive blood culture, i.e. the growth of at least one species of bacteria or micromyces in at least one blood culture vial
- Patient Hospitalized at Grenoble University Hospital (only North site) and seen by a physician from the antibiotic stewardship team
- First blood culture positive for the patient's sepsis episode
- Informed and written consent signed by the patient or his legal representative or the doctor in case of emergency.
Who cannot join
- Patients mentioned in the law articles L1121-5 to L1121-8 from French Health Code
- Patients hospitalized in palliative care unit
- Persons with an estimated survival of less than one month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia or Fungemia From Positive Blood Culture Bottles, Combining Fast Identification of Bacteria and Fungi and Evaluation of Bacterial Resistance to First Line Antibiotics.
This study evaluates the clinical benefit of a rapid test for fast diagnosis of bacteremia and fungemia from positive blood cultures in case of sepsis. This assay enables rapid identification of bacteria and fungi and allows to evaluate bacterial resistance to first line antibiotics. The clinical and medico-economic impact of this assay used in addition to the current diagnosis strategy (half of the patients) will be compared to the current diagnostic strategy alone (other half of the patient).
Read the detailed description
Bacteremia and fungemia are severe complications, sometimes life-threatening, of every sepsis. During septicemia, every hour matters to start an appropriate antibiotic or antifungal treatment as every hour of delay is associated to higher death rate.
The rapid multiplex PCR assay that is evaluated in this study allows to identify in 60 to 90 minutes, the bacteria or fungi that is present in the positive blood culture bottles and to identify resistance markers to first line antibiotics that are used to treat sepsis. This strategy allows quicker adaptation of antibacterial or antifungal treatment based on the species of the bacteria or fungi identified and on the results of the resistance markers compared to current diagnosis strategy of bacteremia or fungemia. This quicker adaptation could lead to improved survival rate, reduced complications of sepsis, reduced hospital stay length and could reduce the use of large spectrum antibiotics.
- Conditions
- Bacteremia Sepsis, Fungemia
- Being tested
- Multiplex PCR, Current strategy alone
- Keywords
- multiplex PCR, blood culture, rapid diagnosis
- Medical subject headings
- Fungemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex PCRDiagnostic test
Quick adaptation of antibiotic treatment according to the species identified and to the results of the resistance markers present in the multiplex PCR
Current strategy aloneDiagnostic test
Also called MALDI-TOFF identification
Identification of bacteria and micromyces isolated in blood cultures after subculture by mass spectrometry (MALDI-TOF) and determination of their sensitivity to antibiotics or antifungals by antibiotic susceptibility testing or antifungigram
| Study group | Role | What they receive |
|---|---|---|
| Multiplex PCR + Current strategy | Experimental | Results of the multiplex PCR will be send as soon as possible to the infectious disease phycian for quick adaptation of antibiotic treatment. Positive blood cultures will also undergo current diagnosis strategy for bacteremia and fungemia. Receives: Diagnostic Test: Multiplex PCR |
| Current strategy alone | Active comparator | Current diagnostic strategy based on the identification of bacteria and micromyces isolated in blood cultures after subculture by mass spectrometry (MALDI-TOF) and determination of their sensitivity to antibiotics or antifungals by antibiotic susceptibility testing or antifungigram Receives: Diagnostic Test: Current strategy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay from suspicion of sepsis to optimized antibiotic/antifungal treatment
Delay between first sampling of blood cultures for sepsis and optimized antibiotic/antifungal treatment. Treatment will be considered optimized if it is active on the bacteria/fungi responsible for sepsis and if it follows current treatment recommendations for the bacteria/fungi identified.
Measured: Follow up is set to hospital length stay with a maximum of 30 days
Secondary outcomes (11)
Medical evaluation of the consequences of the innovative strategy compared to current strategy : 30-day mortality
The following clinical consequences will be measured and compared in each arm : 30-day mortality
Measured: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : complication rate
The following clinical consequences will be measured and compared in each arm : complication rate (ICU admission or length of stay, antibiotic/antifungal treatment toxicity rate, recurrence of sepsis within 30 days, re-admission to hospital within 30 days)
Measured: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : length of hospital stay
The following clinical consequences will be measured and compared in each arm : length of hospital stay
Measured: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : antibiotic treatment duration
The following clinical consequences will be measured and compared in each arm : treatment duration for antibiotics with high impact on the commensal flora (i.e. : carbapenems) or with high toxicity (i.e. : vancomycin)
Measured: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : delay of antibiotic/antifungal treatment modification at several time points
The following clinical consequences will be measured and compared in each arm : delay of antibiotic/antifungal treatment modification at several time points (after the result of the Gram stain, after the results of the multiplex PCR, after the results of the identification of the bacteria/fungi and after the results of antibiotic/antifungal treatment susceptibility).
Measured: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : rate of antibiotic/antifungal treatment modification at several time points
The following clinical consequences will be measured and compared in each arm : rate of antibiotic/antifungal treatment modification at several time points (after the result of the Gram stain, after the results of the multiplex PCR, after the results of the identification of the bacteria/fungi and after the results of antibiotic/antifungal treatment susceptibility).
Measured: Hospital length stay with a maximum of 30 days
Economic evaluation of the hospitalization costs of the innovative strategy compared to current strategy
Hospitalization costs will be measured
Measured: Hospital length stay with a maximum of 30 days
Economic evaluation of the treatments costs of the innovative strategy compared to current strategy
Anti-infectious treatment costs will be measured
Measured: Hospital length stay with a maximum of 30 days
Economic evaluation of the costs of the innovative compared to current strategy
Costs of the innovative assay (reagents and device) will be measured
Measured: Hospital length stay with a maximum of 30 days
Economic evaluation of the medical imaging costs of the innovative strategy compared to current strategy
Medical imaging costs will be measured
Measured: Hospital length stay with a maximum of 30 days
Economic impact of the introduction of the innovative strategy for Grenoble University Hospital
Measurement and evaluation of the economic impact of the innovative strategy on the budget of Grenoble University Hospital, on the target population, for a period of one year.
Measured: Extrapolation of the costs for a one year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start20 Jun 2019
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bacteremia SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized assignation. Half of the patients will be diagnosed by the rapid test in addition to current diagnosis strategy and the other half by current diagnosis strategy alone.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- GenMark Diagnostics
- Responsible party
- Sponsor
- Investigators
- Yvan CASPAR, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876990
- Sponsor's protocol ID
- 38RC15.091
- Acronym
- HEMOFAST
- Status last verified
- Oct 2021
- First submitted
- 11 Mar 2019
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang TD, Melnik E, Bogaerts P, Evrard S, Glupczynski Y. Evaluation of the ePlex Blood Culture Identification Panels for Detection of Pathogens in Bloodstream Infections. J Clin Microbiol. 2019 Jan 30;57(2):e01597-18. doi: 10.1128/JCM.01597-18. Print 2019 Feb.
PubMed 30487304Banerjee R, Teng CB, Cunningham SA, Ihde SM, Steckelberg JM, Moriarty JP, Shah ND, Mandrekar JN, Patel R. Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing. Clin Infect Dis. 2015 Oct 1;61(7):1071-80. doi: 10.1093/cid/civ447. Epub 2015 Jul 20.
PubMed 26197846Kumar 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 16625125Patel TS, Kaakeh R, Nagel JL, Newton DW, Stevenson JG. Cost Analysis of Implementing Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry Plus Real-Time Antimicrobial Stewardship Intervention for Bloodstream Infections. J Clin Microbiol. 2016 Dec 28;55(1):60-67. doi: 10.1128/JCM.01452-16. Print 2017 Jan.
PubMed 27795335Maubon D, Dard C, Garnaud C, Cornet M. Profile of GenMark's ePlex(R) blood culture identification fungal pathogen panel. Expert Rev Mol Diagn. 2018 Feb;18(2):119-132. doi: 10.1080/14737159.2018.1420476. Epub 2017 Dec 28.
PubMed 29284316Timbrook TT, Morton JB, McConeghy KW, Caffrey AR, Mylonakis E, LaPlante KL. The Effect of Molecular Rapid Diagnostic Testing on Clinical Outcomes in Bloodstream Infections: A Systematic Review and Meta-analysis. Clin Infect Dis. 2017 Jan 1;64(1):15-23. doi: 10.1093/cid/ciw649. Epub 2016 Sep 26.
PubMed 27678085
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia or Fungemia From Positive Blood Culture Bottles, Combining Fast Identification of Bacteria and Fungi and Evaluation of Bacterial Resistance to First Line Antibiotics.
- ClinicalTrials.gov ID
- NCT03876990
- Acronym / sponsor ID
- HEMOFAST / 38RC15.091
- Conditions
- Bacteremia Sepsis, Fungemia
- Keywords
- multiplex PCR, blood culture, rapid diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- GenMark Diagnostics
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 15 Mar 2019 (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.
This study evaluates the clinical benefit of a rapid test for fast diagnosis of bacteremia and fungemia from positive blood cultures in case of sepsis. This assay enables rapid identification of bacteria and fungi and allows to evaluate bacterial resistance to first line antibiotics. The clinical and medico-economic impact of this assay used in addition to the current diagnosis strategy (half of the patients) will be compared to the current diagnostic strategy alone (other half of the patient).
Detailed description
Bacteremia and fungemia are severe complications, sometimes life-threatening, of every sepsis. During septicemia, every hour matters to start an appropriate antibiotic or antifungal treatment as every hour of delay is associated to higher death rate.
The rapid multiplex PCR assay that is evaluated in this study allows to identify in 60 to 90 minutes, the bacteria or fungi that is present in the positive blood culture bottles and to identify resistance markers to first line antibiotics that are used to treat sepsis. This strategy allows quicker adaptation of antibacterial or antifungal treatment based on the species of the bacteria or fungi identified and on the results of the resistance markers compared to current diagnosis strategy of bacteremia or fungemia. This quicker adaptation could lead to improved survival rate, reduced complications of sepsis, reduced hospital stay length and could reduce the use of large spectrum antibiotics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized assignation. Half of the patients will be diagnosed by the rapid test in addition to current diagnosis strategy and the other half by current diagnosis strategy alone.
| Arm | Type | Receives |
|---|---|---|
| Multiplex PCR + Current strategy | Experimental | Diagnostic Test: Multiplex PCRResults of the multiplex PCR will be send as soon as possible to the infectious disease phycian for quick adaptation of antibiotic treatment. Positive blood cultures will also undergo current diagnosis strategy for bacteremia and fungemia. |
| Current strategy alone | Active comparator | Diagnostic Test: Current strategy aloneCurrent diagnostic strategy based on the identification of bacteria and micromyces isolated in blood cultures after subculture by mass spectrometry (MALDI-TOF) and determination of their sensitivity to antibiotics or antifungals by antibiotic susceptibility testing or antifungigram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with bacteremia and/or fungemia defined by :
- 1/ the presence of clinical signs of sepsis; AND 2/ a positive blood culture, i.e. the growth of at least one species of bacteria or micromyces in at least one blood culture vial
- Patient Hospitalized at Grenoble University Hospital (only North site) and seen by a physician from the antibiotic stewardship team
- First blood culture positive for the patient's sepsis episode
- Informed and written consent signed by the patient or his legal representative or the doctor in case of emergency.
Key exclusion criteria (3 listed)
- Patients mentioned in the law articles L1121-5 to L1121-8 from French Health Code
- Patients hospitalized in palliative care unit
- Persons with an estimated survival of less than one month
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 |
|---|---|---|
| Multiplex PCRQuick adaptation of antibiotic treatment according to the species identified and to the results of the resistance markers present in the multiplex PCR | Diagnostic test | Multiplex PCR + Current strategy |
| Current strategy aloneAlso: MALDI-TOFF identificationIdentification of bacteria and micromyces isolated in blood cultures after subculture by mass spectrometry (MALDI-TOF) and determination of their sensitivity to antibiotics or antifungals by antibiotic susceptibility testing or antifungigram | Diagnostic test | Current strategy alone |
Primary outcome
Delay from suspicion of sepsis to optimized antibiotic/antifungal treatment
Time frame: Follow up is set to hospital length stay with a maximum of 30 days
Delay between first sampling of blood cultures for sepsis and optimized antibiotic/antifungal treatment. Treatment will be considered optimized if it is active on the bacteria/fungi responsible for sepsis and if it follows current treatment recommendations for the bacteria/fungi identified.
11 secondary outcomes
Medical evaluation of the consequences of the innovative strategy compared to current strategy : 30-day mortality
Time frame: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : complication rate
Time frame: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : length of hospital stay
Time frame: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : antibiotic treatment duration
Time frame: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : delay of antibiotic/antifungal treatment modification at several time points
Time frame: Hospital length stay with a maximum of 30 days
Medical evaluation of the consequences of the innovative strategy compared to current strategy : rate of antibiotic/antifungal treatment modification at several time points
Time frame: Hospital length stay with a maximum of 30 days
Economic evaluation of the hospitalization costs of the innovative strategy compared to current strategy
Time frame: Hospital length stay with a maximum of 30 days
Economic evaluation of the treatments costs of the innovative strategy compared to current strategy
Time frame: Hospital length stay with a maximum of 30 days
Economic evaluation of the costs of the innovative compared to current strategy
Time frame: Hospital length stay with a maximum of 30 days
Economic evaluation of the medical imaging costs of the innovative strategy compared to current strategy
Time frame: Hospital length stay with a maximum of 30 days
Economic impact of the introduction of the innovative strategy for Grenoble University Hospital
Time frame: Extrapolation of the costs for a one year period
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 3 Nov 2021.
- Background: PubMed 30487304Huang TD, Melnik E, Bogaerts P, Evrard S, Glupczynski Y. Evaluation of the ePlex Blood Culture Identification Panels for Detection of Pathogens in Bloodstream Infections. J Clin Microbiol. 2019 Jan 30;57(2):e01597-18. doi: 10.1128/JCM.01597-18. Print 2019 Feb.
- Background: PubMed 26197846Banerjee R, Teng CB, Cunningham SA, Ihde SM, Steckelberg JM, Moriarty JP, Shah ND, Mandrekar JN, Patel R. Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing. Clin Infect Dis. 2015 Oct 1;61(7):1071-80. doi: 10.1093/cid/civ447. Epub 2015 Jul 20.
- 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 27795335Patel TS, Kaakeh R, Nagel JL, Newton DW, Stevenson JG. Cost Analysis of Implementing Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry Plus Real-Time Antimicrobial Stewardship Intervention for Bloodstream Infections. J Clin Microbiol. 2016 Dec 28;55(1):60-67. doi: 10.1128/JCM.01452-16. Print 2017 Jan.
- Background: PubMed 29284316Maubon D, Dard C, Garnaud C, Cornet M. Profile of GenMark's ePlex(R) blood culture identification fungal pathogen panel. Expert Rev Mol Diagn. 2018 Feb;18(2):119-132. doi: 10.1080/14737159.2018.1420476. Epub 2017 Dec 28.
- Background: PubMed 27678085Timbrook TT, Morton JB, McConeghy KW, Caffrey AR, Mylonakis E, LaPlante KL. The Effect of Molecular Rapid Diagnostic Testing on Clinical Outcomes in Bloodstream Infections: A Systematic Review and Meta-analysis. Clin Infect Dis. 2017 Jan 1;64(1):15-23. doi: 10.1093/cid/ciw649. Epub 2016 Sep 26.
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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.
Yvan CASPAR, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiplex PCR and Current strategy alone in people with Bacteremia Sepsis and Fungemia, run by University Hospital, Grenoble at 1 site in France.
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 5 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 3 Nov 2021. 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 France. 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?
Delay from suspicion of sepsis to optimized antibiotic/antifungal treatment (time frame: Follow up is set to hospital length stay with a maximum of 30 days). 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 NCT03876990, which also lists 6 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 3 Nov 2021.