An interventional study of Multiplex PCR and Current strategy alone in Bacteremia Sepsis and Fungemia, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-03.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Diagnostic
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).
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.
32 studies on the registry are indexed under Fungemia; 3 are open to participants now.
This study's enrollment of 312 is above the median of 200 across 20 interventional studies indexed under Fungemia.
Browse Fungemia studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
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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
Exclusion Criteria:
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.
Diagnostic Test: Multiplex PCR
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
Diagnostic Test: Current strategy alone
Quick adaptation of antibiotic treatment according to the species identified and to the results of the resistance markers present in the multiplex PCR
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
Also known as: MALDI-TOFF identification
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.
Time frame: Follow up is set to hospital length stay with a maximum of 30 days
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
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
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)
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
The following clinical consequences will be measured and compared in each arm : 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
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)
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
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).
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
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).
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
Hospitalization costs will be measured
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
Anti-infectious treatment costs will be measured
Time frame: 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
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
Medical imaging costs will be measured
Time frame: 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.
Time frame: Extrapolation of the costs for a one year period
Ran from Jun 2019 to primary completion in Feb 2021, 19 months.
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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