Procalcitonin to Reduce Long-Term Infection-associated Adverse Events in Sepsis. A Randomized Trial

Kyriazopoulou, Evdoxia; Liaskou-Antoniou, Lydia; Adamis, George; Panagaki, Antonia; Melachroinopoulos, Nikolaos; Drakou, Elina; Marousis, Konstantinos D.; Chrysos, Georgios; Spyrou, A; Alexiou, Nikolaos; Symbardi, Styliani; Alexiou, Zoi; Lagou, Styliani; Kolonia, Virginia; Gkavogianni, Theologia; Kyprianou, Miltiades; Anagnostopoulos, Ioannis; Poulakou, Garyfallia; Lada, Malvina; Makina, Anna; Roulia, Efrosyni; Koupetori, Marina; Apostolopoulos, Vasileios; Petrou, Dimitra; Nitsotolis, Thomas; Antoniadou, Anastasia; Giamarellos‐Bourboulis, Evangelos J.

doi:10.1164/rccm.202004-1201oc

Cited by 94 publications

(82 citation statements)

References 33 publications

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“…This is a substudy of patients with sepsis due to LRTI enrolled in the PROGRESS trial [ 4 ]. PROGRESS was a prospective, multicenter, randomized trial designed to evaluate a procalcitonin (PCT)-guided antibiotic stopping rule compared to standard-of-care treatment, for the incidence of infection-associated adverse events in patients with sepsis (ClinicalTrials.gov NCT03333304, 06/11/2017).…”

Section: Methodsmentioning

confidence: 99%

“…PROGRESS (PROcalcitonin-Guided antimicrobial therapy to REduce long-term Sequelae of infectionS) is a prospective randomized clinical trial aiming to validate the impact of early stop of antibiotics guided by procalcitonin (PCT) in the prevention of infections by multidrug-resistant microorganisms (MDRO) and Clostridiodes difficile [ 4 ]. Enrolled patients had sepsis due to either lower respiratory tract infections (LRTI) or acute pyelonephritis (AP) or primary bloodstream infection (BSI).…”

Section: Introductionmentioning

confidence: 99%

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BioFire® FilmArray® Pneumonia Panel for Severe Lower Respiratory Tract Infections: Subgroup Analysis of a Randomized Clinical Trial

et al. 2021

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Introduction The epidemiology of severe lower respiratory tract infections (LRTI) is constantly changing. We aimed to describe it using the BioFire ® FilmArray ® Pneumonia plus (PN plus ) Panel. Methods In a sub-study of the PROGRESS trial, sputum samples of 90 patients with sepsis and LRTI were retrospectively studied. The primary endpoint was the comparative detection rate of pathogens between conventional microbiology and PN plus Panel; secondary endpoints were microbiology and the association with the inflammatory host response. Results Fifty-six patients with community-acquired pneumonia without risk factors for multidrug-resistant (MDR) pathogens and another 34 patients with risk factors for MDR were studied; median pneumonia severity index (PSI) was 113 (88–135). PN plus detection rate was 72.2% compared to 10% by conventional microbiology ( p < 0.001); Streptococcus pneumoniae was the most common pathogen. PSI and procalcitonin were greater among patients with bacterial pathogens than viral pathogens. Median procalcitonin was 0.49 ng/ml and 0.18 ng/ml among patients with ≥ 10 5 and < 10 5 copies/ml of detected bacteria, respectively ( p = 0.004). Resistance reached 14.4%. Conclusion PN plus detects severe pneumonia pathogens at a greater rate than conventional microbiology. High levels of inflammation accompany bacterial detection. Trial Registration PROGRESS, ClinicalTrials.gov NCT03333304, 06/11/2017. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-021-00459-x.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

BioFire® FilmArray® Pneumonia Panel for Severe Lower Respiratory Tract Infections: Subgroup Analysis of a Randomized Clinical Trial

et al. 2021

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“…After adjustment, no statistically significant effect of the PCTbased protocol was observed on hospital length of stay (AD ¼ -0.14 days, 95%CI: À0.83; 0.55, p ¼ .690), ICU length of stay (AD ¼ 0.03 days, 95%CI: À0. 13…”

Section: Secondary Outcomesmentioning

confidence: 99%

“…acute bronchitis, exacerbations of chronic obstructive pulmonary disease [COPD], and pneumonia) and sepsis, without adverse effects on mortality, length of stay in the intensive care unit (ICU), or length of hospital stay [9][10][11][12] . A recent randomized trial also found that PCT guidance may have benefits on long-term patient outcomes, including lower rates of infection-associated adverse events at 6 months among patients with sepsis 13 . A 2018 systematic review and meta-analysis of 11 RCTs evaluating the impact of PCT guidance in patients with LRTIs found statistically significant reductions in AB duration (weighted mean difference: À2.15 days, 95% confidence interval [CI]: À3.30; À0.99) and in the odds of initiating AB (odds ratio: 0.26, 95%CI: 0.13; 0.52) 10 .…”

Section: Introductionmentioning

confidence: 98%

Decreased antibiotic exposure using a procalcitonin protocol for respiratory infections and sepsis in US community hospitals (ProCommunity)

DeSear¹,

Thompson‐Leduc

Schooneveld

et al. 2021

Current Medical Research and Opinion

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Objective: Antibiotic overuse leading to antimicrobial resistance is a global public health concern. Clinical trials have demonstrated that procalcitonin-based decision-making for antibiotic therapy can safely decrease inappropriate antibiotic use in patients with respiratory infections and sepsis, but realworld data are scarce. This study sought to assess the impact of a procalcitonin-based antibiotic stewardship program (protocol plus education) on antibiotic use in community hospitals. Methods: An observational, retrospective, matched cohort study was conducted. Eligible patients treated in hospitals with a procalcitonin-based protocol plus education (Procalcitonin cohort hospitals) were matched to patients admitted to facilities without procalcitonin testing (Control cohort hospitals) using a 1:2 ratio. The Control hospitals were facilities where procalcitonin testing was not available on site. Patient matching was based on: (1) age, (2) gender, (3) admission diagnosis code using groupings of the International Classification of Diseases, 10th Revision, (4) whether patients were admitted to the intensive care unit, and (5) whether a blood culture test was performed. Procalcitonin cohort hospitals implemented a quality improvement initiative, where procalcitonin was available, used regularly, and clinicians (physicians and pharmacists) were educated on its use. Results: After adjustment, patients in the Procalcitonin cohort had 1.47 fewer antibiotic days (9.1 vs. 8.5 days, 95%CI: À2.72; À0.22, p ¼ .021). There was no difference in length of stay or adverse clinical outcomes except for increase in acute kidney injury (odds ratio ¼ 1.26, 95%CI: 1.01; 1.58, p ¼ .038). Conclusions: Patients with respiratory infections and sepsis in hospitals utilizing a procalcitonin-based protocol coupled with education received fewer days of antibiotic therapy.

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“…White blood cell count, C-reactive protein and procalcitonin most often used to diagnose bacterial infections[5, 7] while there are no established markers for viral infections. Several European trials demonstrated that procalcitonin-guided management reduces antibiotic use[8, 9]; however, the incremental value of procalcitonin when used along best practice promotion of current guidelines has been questioned and a large US multicenter interventional trial failed to show a reduction in antibiotic use[10].…”

Section: Introductionmentioning

confidence: 99%

A 29-mRNA Host Response Test from Blood Accurately Distinguishes Bacterial and Viral Infections Among Emergency Department Patients

Safarika

Wacker²,

Katsaros

et al. 2020

Preprint

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Study designWhether or not to administer antibiotics is a common and challenging clinical decision in patients with suspected infections presenting to the emergency department (ED). We prospectively validate InSep, a 29-mRNA blood-based host response test for the prediction of bacterial and viral infections.MethodsThe PROMPT trial is a prospective, non-interventional, multi-center randomized, controlled clinical trial that enrolled 397 adult patients presenting to the ED with signs of acute infection and at least one vital sign change. The infection status was adjudicated using chart review (including a syndromic molecular respiratory panel, procalcitonin and C-reactive protein) by three infectious disease physicians blinded to InSep results. InSep (version BVN-2) was performed using PAXgene Blood RNA processed and quantified on NanoString nCounter SPRINT. InSep results (likelihood of bacterial and viral infection) were compared to the adjudicated infection status.ResultsSubject mean age was 64 years, comorbidities were significant for diabetes (17.1%), chronic obstructive pulmonary disease (13.6%), and severe neurological disease (6.8%); 16.9% of subjects were immunocompromised. Infections were adjudicated as bacterial (14.1%), viral (11.3%) and noninfected (0.25%): 74.1% of subjects were adjudicated as indeterminate. InSep distinguished bacterial vs. viral/noninfected patients and viral vs. bacterial/noninfected patients using consensus adjudication with AUROCs of 0.94 (95% CI 0.90-0.99) and 0.90 (95% CI 0.83-0.96), respectively. AUROCs for bacterial vs. viral/noninfected patients were 0.88 (95%CI 0.79-0.96) for PCT, 0.80 (95% CI 0.72-89) for CRP and 0.78 (95% CI 0.69-0.87) for white blood cell counts (of note, the latter biomarkers were provided as part of clinical adjudication). To enable clinical actionability, InSep incorporates score cutoffs to allocate patients into interpretation bands. The Very Likely (rule in) InSep bacterial band showed a specificity of 98% compared to 94% for the corresponding PCT band (>0.5 ug/L); the Very Unlikely (rule-out) band showed a sensitivity of 95% for InSep compared to 86% for PCT. For the detection of viral infections, InSep demonstrated a specificity of 93% for the Very Likely band (rule in) and a sensitivity of 96% for the Very Unlikely band (rule out).ConclusionInSep demonstrated high accuracy for predicting the presence of both bacterial and viral infections in ED patients with suspected acute infections or suspected sepsis. When translated into a rapid, point-of-care test, InSep will provide ED physicians with actionable results supporting early informed treatment decisions to improve patient outcomes while upholding antimicrobial stewardship.Take-home messageInSep host response test is a point-of-care test providing with accuracy the likelihood for bacterial or viral infection for patients admitted at the emergencies InSep provided information on the likelihood of bacterial co-infection among patients with COVID-19.

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Procalcitonin to Reduce Long-Term Infection-associated Adverse Events in Sepsis. A Randomized Trial

Cited by 94 publications

References 33 publications

BioFire® FilmArray® Pneumonia Panel for Severe Lower Respiratory Tract Infections: Subgroup Analysis of a Randomized Clinical Trial

BioFire® FilmArray® Pneumonia Panel for Severe Lower Respiratory Tract Infections: Subgroup Analysis of a Randomized Clinical Trial

Decreased antibiotic exposure using a procalcitonin protocol for respiratory infections and sepsis in US community hospitals (ProCommunity)

A 29-mRNA Host Response Test from Blood Accurately Distinguishes Bacterial and Viral Infections Among Emergency Department Patients

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