Rapid Diagnosis of Infection in the Critically Ill, a Multicenter Study of Molecular Detection in Bloodstream Infections, Pneumonia, and Sterile Site Infections*

Vincent, Jean‐Louis; Brealey, David; Libert, Nicolas; Abidi, Nour; O’Dwyer, Michael J.; Zacharowski, Kai; Mikaszewska-Sokolewicz, Małgorzata; Schrenzel, Jacques; Simon, François; Wilks, Mark; Picard‐Maureau, Marcus; Chalfin, Donald B.; Ecker, David J.; Sampath, Rangarajan; Singer, Mervyn

doi:10.1097/ccm.0000000000001249

Cited by 168 publications

(138 citation statements)

References 29 publications

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“…Lately, a PCR/electrospray ionization-mass spectrometry (PCR/ ESI) technology was developed to detect more than 800 bloodstream infection-relevant bacterial and Candida species within 6 h of sample acquisition. Findings from the RADICAL study showed 81% sensitivity, 69% specificity, and 97% negative predictive value with PCR/ESI when compared with conventional cultures [74]. In a set of prospectively collected blood samples in sepsis patients, PCR/ESI and standard microbiology were concordant in 86% of culture-positive samples [75].…”

Section: What Are Remaining Areas Of Uncertainty? Invasive Candidiasismentioning

confidence: 93%

Intensive care medicine research agenda on invasive fungal infection in critically ill patients

et al. 2017

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Purpose:To describe concisely the current standards of care, major recent advances, common beliefs that have been contradicted by recent trials, areas of uncertainty, and clinical studies that need to be performed over the next decade and their expected outcomes with regard to Candida and Aspergillus infections in non-neutropenic patients in the ICU setting. Methods:A systematic review of the medical literature taking account of national and international guidelines and expert opinion. Results:Severe invasive fungal infections (IFIs) are becoming increasingly frequent in critically ill patients. Approximately 80% of IFIs are due to Candida spp. and 0.3-19% to Aspergillus spp. Recent observations emphasize the necessity of building a worldwide sentinel network to monitor the emergence of new fungal species and changes in susceptibility. Robust data on the attributable mortality are essential for the design of clinical studies with mortality endpoints. Although early antifungal therapy for Candida has been recommended in patients with risk factors, sepsis of unknown cause, and positive Candida serum biomarkers [β-1 → 3-d-glucan (BDG) and Candida albicans germ tube antibody (CAGTA)], its usefulness and influence on outcome need to be confirmed. Future studies may specifically address the optimal diagnostic and therapeutic strategies for patients with abdominal candidiasis. Better knowledge of the pharmacokinetics of antifungal molecules and tissue penetration is a key issue for intensivists. Regarding invasive aspergillosis, further investigation is needed to determine its incidence in the ICU, its relationship with influenza outbreaks, the clinical impact of rapid diagnosis, and the significance of combination treatment. Conclusions:Fundamental questions regarding IFI have to be addressed over the next decade. The clinical studies described in this research agenda should provide a template and set priorities for the clinical investigations that need to be performed.

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Section: What Are Remaining Areas Of Uncertainty? Invasive Candidiasismentioning

confidence: 93%

Intensive care medicine research agenda on invasive fungal infection in critically ill patients

et al. 2017

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“…A study involving 616 BSIs and 185 pneumonia cases tested the PlexID ™ platform, which is able to detect 800 relevant pathogens. The system identified 55 of the 68 positive blood cultures, but was also positive in 173/625 of negative blood cultures [8]. The interpretation and therapeutic implications of recovering positive PCR in the absence of positive microbial culture remain debated.…”

Section: Rapid Diagnostic Tests For Selecting Adequate Antimicrobialsmentioning

confidence: 99%

Focus on optimization of early antimicrobial therapy in ICU-acquired infections

Timsit

Paiva²,

Bassetti

2016

Intensive Care Med

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“…Beginning with blood culture collection, there is growing interest and success in direct-from-blood pathogen detection assays. Some progress has already been made in this domain, including SeptiFast [4], IRIDICA [5], and T2 Biosystems [6], although only the last is FDA cleared, and only for detection of Candida species. A MASTERMIND protocol for direct-from-blood pathogen detection could theoretically collect enough blood from each enrolled subject to submit for multiple test evaluations (Figure 3), though required volumes may sometimes be limiting and may not enable a large number of diagnostics to be run on a single specimen.…”

Section: Mastermind Study Possibilitiesmentioning

confidence: 99%

MASTERMIND: Bringing Microbial Diagnostics to the Clinic

Patel

Tsalik

Petzold

et al. 2016

CLINID

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New diagnostics are urgently needed to address emerging antimicrobial resistance. The Antibacterial Resistance Leadership Group proposes a strategy called MASTERMIND (Master Protocol for Evaluating Multiple Infection Diagnostics) for advancement of infectious diseases diagnostics. The goal of this strategy is to generate the data necessary to support US Food and Drug Administration clearance of new diagnostic tests by promoting research that might not have otherwise been feasible with conventional trial designs. MASTERMIND uses a single subject's sample(s) to evaluate multiple diagnostic tests at the same time, providing efficiencies of specimen collection and characterization. MASTERMIND also offers central trial organization, standardization of methods and definitions, and common comparators.

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Rapid Diagnosis of Infection in the Critically Ill, a Multicenter Study of Molecular Detection in Bloodstream Infections, Pneumonia, and Sterile Site Infections*

Abstract: Supplemental Digital Content is available in the text.

Cited by 168 publications

References 29 publications

Intensive care medicine research agenda on invasive fungal infection in critically ill patients

Intensive care medicine research agenda on invasive fungal infection in critically ill patients

Focus on optimization of early antimicrobial therapy in ICU-acquired infections

MASTERMIND: Bringing Microbial Diagnostics to the Clinic

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