Search Results (35)

Background: Sepsis remains a significant cause of morbidity and mortality in preterm and low birth weight (LBW) neonates, especially in low- and middle-income countries (LMICs). Lactoferrin, a glycoprotein present in breast milk with antimicrobial activity, is a low-cost, readily available, and promising intervention currently under investigation. The available literature presents conflicting results on the impact of lactoferrin on the risk of late-onset sepsis (LOS). This study evaluated the effectiveness of two doses of bovine lactoferrin (bLF) supplementation in preventing LOS and necrotizing enterocolitis (NEC) in preterm and LBW neonates in Pakistan. Methods: A three-arm, double-blind, placebo-controlled, randomized clinical trial in the neonatal intensive care unit of Aga Khan University was conducted from July 2019 to August 2020. Preterm (28 to 36 + 5 weeks gestational age) and low birth weight (≥1000 g to <2500 g) neonates who established enteral feeding by 72 h were eligible. The exclusion criteria included sepsis before randomization, maternal history of chorioamnionitis or group B streptococcus colonization, and congenital anomalies. Enrolled neonates were randomly assigned in a 1:1:1 ratio using a computer-generated random allocation sequence to receive placebo (D-glucose), 150 mg bLF, or 300 mg bLF mixed with breast milk once daily for 28 days. The study staff, parents, and outcome assessors were blinded to the allocation. The primary outcome was late-onset sepsis from the trial entry to 28 days. The secondary outcome was NEC from the trial entry to 28 days. Neonates were followed weekly for 28 ± 2 days, and episodes of LOS and NEC were recorded. Results: Of 305 neonates enrolled, 102, 102, and 101, respectively, were randomized to receive a placebo (arm A), 150 mg bLF (arm B), and 300 mg bLF (arm C), respectively. Outcome data of 291 participants (99 in arm A, 95 in arm B, and 97 in arm C) were available for inclusion in the intention-to-treat analysis. The frequency of culture-proven sepsis was 8/102 (7.8%) in arm A compared to 1/102 (0.98%) (p = 0.020) in arm B and 5/101 (4.9%) in arm C (p = 0.390). We did not find any difference in episodes of NEC between arms A (n = 3, 3%) and B (n = 0, 0%) (p = 0.087) or between arms A and C (n = 2, 2%) (p = 0.650). We reported compliance rates of 79 (79.79%) in arm A, 78 (82.1%) in arm B, and 82 (84.53%) in arm C for investigational products. Arm C recorded two deaths, but neither was attributed to the intervention. Conclusions: Bovine lactoferrin supplementation did not prevent late-onset sepsis in neonates of preterm and low birth weight in our trial. However, given the small sample size, further trials with larger sample sizes are required to investigate its efficacy in these at-risk groups. Full article

Background/Objective: Late-onset sepsis (LOS), a systemic infection occurring after 72 h of life, is a significant issue of morbidity and mortality in preterm neonates. Nevertheless, in this population, cultures frequently remain negative, even in the presence of typical clinical signs of sepsis. Materials and Methods: This single-center, retrospective study included preterm infants with a birth weight (BW) < 1500 g and/or a gestational age (GA) ≤ 32 weeks, diagnosed with culture-negative LOS (CNLOS) and culture-proven LOS (CPLOS). The study aimed to determine the incidence of these conditions, describe the frequency of isolated pathogens, and compare clinical profiles, antibiotic usage, morbidity, and mortality between these two groups as well as a no-sepsis group. Results: Among 277 infants, 30 (10.8%) had CPLOS, 83 (30%) had CNLOS, and 164 (59.2%) had no sepsis. Significant differences were found between the groups regarding BW, GA, hospitalization duration, morbidity, and mortality (p < 0.001). CNLOS and CPLOS did not differ in terms of mechanical ventilation or central line use. However, CPLOS infants had a higher rate of thrombocytopenia (p < 0.001), inotrope use (p = 0.006), and mortality (p < 0.001) compared to CNLOS infants. The duration of antibiotic treatment was similar between groups [median DOT (IQR): 20 (14–33) vs. 20 (14–35), p = 0.935]. In the CPLOS group, Gram-negative pathogens were isolated in 42.4% of infants, with Klebsiella oxytoca being the most common; Gram-positive organisms in 36.3%; and fungi in 21.2%. Conclusions: LOS, whether culture-proven or not, was associated with neonatal morbidity and mortality. CPLOS was linked to a worse prognosis, while CNLOS was also frequently diagnosed and associated with increased antibiotic use in Neonatal Intensive Care Units (NICUs). Full article

Background/Objectives: Severe infection (sInfection; either late-onset culture-proven sepsis or necrotizing enterocolitis) in very low birth weight (VLBW) infants increases mortality rates and may show long-term progression. The fecal microbiome composition in VLBW infants with and without sInfection was classified in the sInfection and non-sInfection groups. Methods: Gut microbiomes, secondary information from a previous randomized trial, were analyzed using QIIME 2 software. The biodiversity and abundance of the gut microbiota between the sInfection and non-sInfection groups were compared. Results: Fifty-one neonates were included in the sInfection (n = 9) and non-sInfection (n = 42) groups; no significant differences in the fecal microbiome were observed in both alpha and beta diversities. Analysis of relative abundance revealed that in both groups, the predominant gut microbiota phylum, class, and genus were Proteobacteria, Gammaproteobacteria, and Klebsiella, respectively. The main fecal microbiome in the non-sInfection group included Faecalibacterium, Clostridium butyricum, and Bacteroides fragilis. Clostridium_sensu_stricto _1 was significantly more abundant in the non-sInfection group than in the sInfection group. Conclusions: Clostridium_sensu_stricto_1 was the main gut microbiota in the non-sInfection group. Considering the potential taxa as synbiotics (correlations among prebiotics, probiotics, and postbiotics), therapeutics may be useful for preventing and managing necrotizing enterocolitis or late-onset culture-proven sepsis in VLBW infants. Full article

Background: Neonatal sepsis is a major cause of infant mortality, and it accounts for a significant consumption of antimicrobials in paediatrics. This is the first comprehensive study on neonatal sepsis in Hong Kong. Methods: From 2014 to 2023, all neonates admitted to a single institution with culture-proven infections from the blood and/or cerebrospinal fluid were selected and reviewed retrospectively. The infecting organisms, their antibiotic nonsusceptibility pattern, and the concordance of empirical antimicrobial therapy with the microbiological profiles were described and were further compared between infants of normal/low birth weight (≥1.5 kg) and very low/extremely low birth weight (<1.5 kg), early-onset sepsis (<72 h), and late-onset sepsis (4–28 days), the first and the second 5-year periods (2014–2018 vs. 2019–2023). Results: After contaminants were excluded, there were 118 affected neonates with 125 organisms identified. Fifty-nine were male. Thirty-four were very low/extremely low birth weight infants, and twenty-eight infants had early-onset sepsis. Patient demographics and the microbiology findings did not differ between the first 5 years and the latter 5 years. However, the incidence of neonatal sepsis was significantly lower in the latter 5 years (3.23 vs. 1.61 per 1000 live births, p < 0.001), the period that coincided with the COVID-19 pandemic. Escherichia coli was the most common Gram-negative pathogen. Streptococcus agalactiae and Streptococcus bovis group infections were more common in early-onset sepsis, while coagulase-negative Staphylococcus and non-E. coli Gram-negative pathogens were more likely to occur in late-onset sepsis. In very low/extremely low birth weight infants, the rate of cefotaxime or ceftriaxone nonsusceptibility among Gram-negative isolates was higher (p = 0.01), and concordance of empirical antimicrobial therapy was lower (p = 0.006). Conclusions: Management of neonatal sepsis remains challenging, and there is a need for optimising antimicrobial therapy, especially in preterm patients. Antepartum screening with intrapartum antibiotic prophylaxis is effective in reducing the risk of early-onset sepsis associated with S. agalactiae, while stringent infection control measures are important for the prevention of late-onset sepsis. Full article

Background: Basic healthcare may significantly decrease neonatal morbidity and mortality. Attention to this, particularly in populations where rates of potentially preventable illness and death within the first weeks of life are extremely high, will have a positive impact on global health. Objective: This manuscript presents the development and impact of a quality improvement programme to reduce the evidence–practice gap in care for neonates admitted to the NICU in a public hospital in India. The programme was locally customised for optimal and sustainable results. Method: The backbone of the project was educational exchange of neonatal nurses and physicians between Norway and India. Areas of potential improvement in the care for the neonates were mainly identified by the clinicians and focus areas were subject to dynamic changes over time. In addition, a service centre for lactation counselling and milk banking was established. Progress over the timeframe 2017–2019 was compared with baseline data. Results: The project has shown that after a collaborative effort, there is a significant reduction in mortality from 11% in the year 2016 to 5.5% in the year 2019. The morbidity was reduced, as illustrated by the decrease in the proportion of neonates with culture-proven sepsis. Nutrition improved with consumption of human milk by the NICU-admitted neonates remarkably increasing from one third to more than three forth of their total intake, and weight gain in a subgroup was shown to increase. With the introduction of family participatory care, hours of skin-to-skin contact for the neonates significantly increased. Additional indicators of improved care were also observed. Conclusions: It is feasible to reduce neonatal mortality and morbidity in a low- and middle-income hospitalised population by improving basic care including nutrition relatively inexpensively when utilising human resources. Full article

Background/Objectives: Early-onset sepsis in neonates is a potentially catastrophic condition that demands prompt management. However, laboratory diagnosis via cerebral spinal fluid and blood tests is often inconclusive, so diagnosis on the basis of clinical symptoms and risk factors is frequently required, and the majority of neonates treated with antibiotics for presumed early-onset sepsis (PEOS) do not have culture-proven sepsis. The management of such PEOS is mainly achieved via antibiotic therapy, which itself has adverse effects, creating a dilemma for clinicians in optimising healthcare. This study aimed to assess the impact of PEOS management on the common neonatal concerns of feeding tolerance, hyperbilirubinaemia, weight gain, and length of stay (LoS) in moderate to late preterm infants. Methods: A single-site, matched-cohort, retrospective study was performed on infants born between 32⁺³ and 36⁺⁶ weeks (2016 to 2019) admitted to the Neonatal Unit. PEOS infants on antibiotics (PEOS) were strictly matched by gestational age (±1 day) and birthweight (±5%) against a non-PEOS reference group (NPEOS). The key outcomes included the following: enteral feeding commencement and achievement; feeding intolerance (FI); phototherapy commencement and duration; antibiotic therapy duration; maximum bilirubin (MaxBili); LoS; and net postbirth weight gain. Results: There were no cases of culture-proven early-onset sepsis. PEOS (n = 185): NPEOS (n = 185) via multivariable analysis showed delayed enteral feed commencement (adjusted Odds Ratio [aOR]: 2.75; 95% confidence interval [CI]: 2.32, 3.27); there was no difference in FI, delayed onset of peak jaundice (aOR: 1.24; 95%CI: 1.12, 1.37), increased duration of phototherapy (aOR: 1.24; 95%CI: 1.10, 1.41), and increased LoS (aOR: 1.31; 95%CI; 1.02, 1.67). A univariate analysis also showed the following results (PEOS: NPEOS): no significant difference in MaxBili and delayed full enteral feed achievement (p = 0.010). Univariant or multivariable analysis showed no difference in irradiance levels. However, for NPEOS infants undergoing 0 or 1 phototherapy light treatment, there was an increased irradiance for PEOS (<0.001, 0.037, respectively). Conclusions: In moderate to late preterm infants, while PEOS diagnosis and management resolve the negative health impacts of potential sepsis, they are associated with negative healthcare outcomes on feeding, jaundice, and hospital length of stay. Full article

Objective: We aimed to determine the demographic data, mortality, and morbidity of early- and late-neonatal sepsis cases, the etiologic agents in these cases, and the antibiotic susceptibility of these agents. Methods: This study was conducted retrospectively in a tertiary neonatal intensive care unit (NICU). The demographic, clinical, and laboratory data of newborns diagnosed with culture-proven sepsis within 24 months were evaluated. Results: Two hundred and eleven culture data points belonging to 197 infants were evaluated. Forty percent of the infants had a history of premature birth. The most common clinical findings were respiratory distress and feeding intolerance. Coagulase-negative staphylococci (CoNS) were detected most frequently as early- and late-sepsis agents. The most common Gram-negative bacteria detected as late-sepsis agents were Klebsiella spp. and Escherichia coli (E. coli). The overall mortality rate was 10%. Conclusions: Neonatal sepsis continues to have high mortality rates in tertiary NICUs. CoNS was the most common agent, highlighting the importance of developing and maintaining personnel training and handwashing practices. It will be important to consider the resistance rates of Klebsiella spp., the most common Gram-negative agent in late-onset sepsis (LOS) cases, to commonly used antibiotics in empirical treatments. Full article

Management of suspected early-onset sepsis (EOS) is undergoing continuous evolution aiming to limit antibiotic overtreatment, yet current data on the level of overtreatment are only available for a select number of countries. This study aimed to determine antibiotic initiation and continuation rates for suspected EOS, along with the incidence of culture-proven EOS in The Netherlands. In this retrospective study from 2019 to 2021, data were collected from 15 Dutch hospitals, comprising 13 regional hospitals equipped with Level I-II facilities and 2 academic hospitals equipped with Level IV facilities. Data included birth rates, number of neonates started on antibiotics for suspected EOS, number of neonates that continued treatment beyond 48 h and number of neonates with culture-proven EOS. Additionally, blood culture results were documented. Data were analysed both collectively and separately for regional and academic hospitals. A total of 103,492 live-born neonates were included. In 4755 neonates (4.6%, 95% CI 4.5–4.7), antibiotic therapy was started for suspected EOS, and in 2399 neonates (2.3%, 95% CI 2.2–2.4), antibiotic treatment was continued beyond 48 h. Incidence of culture-proven EOS was 1.1 cases per 1000 live births (0.11%, 95% CI 0.09–0.14). Overall, for each culture-proven EOS case, 40.6 neonates were started on antibiotics and in 21.7 neonates therapy was continued. Large variations in treatment rates were observed across all hospitals, with the number of neonates initiated and continued on antibiotics per culture-proven EOS case varying from 4 to 90 and from 4 to 56, respectively. The high number of antibiotic prescriptions compared to the EOS incidence and wide variety in clinical practice among hospitals in The Netherlands underscore both the need and potential for a novel approach to the management of neonates with suspected EOS. Full article

Background: There are wide variations in antibiotic use in neonatal intensive care units (NICUs). Limited data are available on antimicrobial stewardship (AS) programs and long-term maintenance of AS interventions in preterm very-low-birth-weight (VLBW) infants. Methods: We extended a single-centre observational study carried out in an Italian NICU. Three periods were compared: I. “baseline” (2011–2012), II. “intervention” (2016–2017), and III. “maintenance” (2020–2021). Intensive training of medical and nursing staff on AS occurred between periods I and II. AS protocols and algorithms were maintained and implemented between periods II and III. Results: There were 111, 119, and 100 VLBW infants in periods I, II, and III, respectively. In the “intervention period”, there was a reduction in antibiotic use, reported as days of antibiotic therapy per 1000 patient days (215 vs. 302, p < 0.01). In the “maintenance period”, the number of culture-proven sepsis increased. Nevertheless, antibiotic exposure of uninfected VLBW infants was lower, while no sepsis-related deaths occurred. Our restriction was mostly directed at shortening antibiotic regimens with a policy of 48 h rule-out sepsis (median days of early empiric antibiotics: 6 vs. 3 vs. 2 in periods I, II, and III, respectively, p < 0.001). Moreover, antibiotics administered for so-called culture-negative sepsis were reduced (22% vs. 11% vs. 6%, p = 0.002), especially in infants with a birth weight between 1000 and 1499 g. Conclusions: AS is feasible in preterm VLBW infants, and antibiotic use can be safely reduced. AS interventions, namely, the shortening of antibiotic courses in uninfected infants, can be sustained over time with periodic clinical audits and daily discussion of antimicrobial therapies among staff members. Full article

(1) Background: Prematurity is a serious condition associated with long-term neurological disability. This study aimed to compare the neurodevelopmental outcomes of preterm neonates with or without sepsis. (2) Methods: This single-center retrospective case–control study included infants with birth weight < 1500 g and/or gestational age ≤ 30 weeks. Short-term outcomes, brain MRI findings, and severe functional disability (SFD) at age 24 months were compared between infants with culture-proven or culture-negative sepsis or without sepsis. A chi-squared test or Mann–Whitney U test was used to compare the clinical and instrumental characteristics and the outcomes between cases and controls. (3) Results: Infants with sepsis (all sepsis n = 76; of which culture-proven n = 33 and culture-negative n = 43) were matched with infants without sepsis (n = 76). Compared with infants without sepsis, both all sepsis and culture-proven sepsis were associated with SFD. In multivariate logistic regression analysis, SFD was associated with intraventricular hemorrhage (OR 4.7, CI 1.7–13.1, p = 0.002) and all sepsis (OR 3.68, CI 1.2–11.2, p = 0.021). (4) Conclusions: All sepsis and culture-proven sepsis were associated with SFD. Compared with infants without sepsis, culture-negative sepsis was not associated with an increased risk of SFD. Given the association between poor outcomes and culture-proven sepsis, its prevention in the neonatal intensive care unit is a priority. Full article

(1) Background: Neonatal early-onset sepsis (EOS) is associated with important mortality and morbidity. The aims of this study were to evaluate the association between serum and hematological biomarkers with early onset neonatal sepsis in a cohort of patients with prolonged rupture of membranes (PROM) and to calculate their diagnostic accuracy. (2) Methods: A retrospective cohort study was conducted on 1355 newborns with PROM admitted between January 2017 and March 2020, who were divided into two groups: group A, with PROM ≥ 18 h, and group B, with ROM < 18 h. Both groups were further split into subgroups: proven sepsis, presumed sepsis, and no sepsis. Descriptive statistics, analysis of variance (ANOVA) and a Random Effects Generalized Least Squares (GLS) regression were used to evaluate the data. (3) Results: The statistically significant predictors of neonatal sepsis were the high white blood cell count from the first (p = 0.005) and third day (p = 0.028), and high C-reactive protein (CRP) values from the first day (p = 0.004). Procalcitonin (area under the curve—AUC = 0.78) and CRP (AUC = 0.76) measured on the first day had the best predictive performance for early-onset neonatal sepsis. (4) Conclusions: Our results outline the feasibility of using procalcitonin and CRP measured on the first day taken individually in order to increase the detection rate of early-onset neonatal sepsis, in the absence of positive blood culture. Full article

Background: To evaluate the rates of lumbar puncture (LP) in infants with culture-proven sepsis. Study design: We prospectively enrolled 400 infants with early- or late-onset sepsis due to Group B streptococcus (GBS) or Eschericha coli, diagnosed within 90 days of life. Rates of LP and potential variables associated with LP performance were evaluated. Moreover, cerebrospinal fluid (CSF) characteristics and results of the molecular analysis were investigated. Results: LP was performed in 228/400 (57.0%) infants; 123/228 LPs (53.9%) were performed after antibiotic initiation, hampering the ability to identify the pathogen in the CSF culture. However, polymerase chain reaction increased the probability of positive results of CSF analysis compared to microbiological culture (28/79, 35.4% vs. 14/79, 17.7%, p = 0.001). Severe clinical presentation and GBS infection were associated with higher LP rates. The rate of meningitis was 28.5% (65/228). Conclusions: Rates of LP are low in culture-proven neonatal sepsis and antibiotics are frequently given before LP is carried out. Thus meningitis may be underestimated, and the chances of giving an effective therapy to the newborn are reduced. LP should be performed before the start of antibiotics when there is a clinical suspicion of infection. Full article

Background: Due to a lack of rapid, accurate diagnostic tools for early-onset neonatal sepsis (EOS) at the initial suspicion, infants are often unnecessarily given antibiotics directly after birth. We aimed to determine the diagnostic accuracy of presepsin for EOS before antibiotic initiation and to investigate whether presepsin can be used to guide clinicians’ decisions on whether to start antibiotics. Methods: In this multicenter prospective observational cohort study, all infants who started on antibiotics for EOS suspicion were consecutively included. Presepsin concentrations were determined in blood samples collected at the initial EOS suspicion (t = 0). In addition to this, samples were collected at 3, 6, 12 and 24 h after the initial EOS suspicion and from the umbilical cord directly after birth. The diagnostic accuracy of presepsin was calculated. Results: A total of 333 infants were included, of whom 169 were born preterm. We included 65 term and 15 preterm EOS cases. At the initial EOS suspicion, the area under the curve (AUC) was 0.60 (95% confidence interval (CI) 0.50–0.70) in the term-born infants compared to 0.84 (95% CI 0.73–0.95) in the preterm infants. A cut-off value of 645 pg/mL resulted in a sensitivity of 100% and a specificity of 54% in the preterm infants. The presepsin concentrations in cord blood and at other time points did not differ significantly from the concentrations at the initial EOS suspicion. Conclusions: Presepsin is a biomarker with an acceptable diagnostic accuracy for EOS (culture-proven and clinical EOS) in preterm infants and might be of value in reducing antibiotic exposure after birth when appended to current EOS guidelines. However, the small number of EOS cases prevents us from drawing firm conclusions. Further research should be performed to evaluate whether appending a presepsin-guided step to current EOS guidelines leads to a safe decrease in antibiotic overtreatment and antibiotic-related morbidity. Full article

Background and Objectives: Patients with urinary tract obstruction (UTO) and systemic inflammatory response syndrome (SIRS) are at risk of developing urosepsis, whose evolution involves increased morbidity, mortality and cost. The aim of this study is to evaluate the ability of already existing scores and biomarkers to diagnose, describe the clinical status, and predict the evolution of patients with complicated urinary tract infection (UTI) and their risk of progressing to urosepsis. Materials and Methods: We conducted a retrospective study including patients diagnosed with UTI hospitalized in the urology department of” Sfântul Apostol Andrei” County Emergency Clinical Hospital (GCH) in Galati, Romania, from September 2019 to May 2022. The inclusion criteria were: UTI proven by urine culture or diagnosed clinically complicated with UTO, fever or shaking chills, and purulent collections, such as psoas abscess, Fournier Syndrome, renal abscess, and paraurethral abscess, showing SIRS. The exclusion criteria were: patients age < 18 years, pregnancy, history of kidney transplantation, hemodialysis or peritoneal dialysis, and patients with missing data. We used the Sequential (Sepsis-Related) Organ Failure Assessment (SOFA) and qSOFA (quick SOFA) scores, and procalcitonin (PCT) to describe the clinical status of the patients. The Charlson Comorbidity Index (CCI) was used to assesses pre-existing morbidities. The hospitalization days and costs and the days of intensive care were considered. Depending on the diagnosis at admission, we divided the patients into three groups: SIRS, sepsis and septic shock. The fourth group was represented by patients who died during hospitalization. Results: A total of 174 patients with complicated UTIs were enrolled in this study. From this total, 46 were enrolled in the SIRS group, 88 in the urosepsis group, and 40 in the septic shock group. A total of 23 patients died during hospitalization and were enrolled in the deceased group. An upward trend of age along with worsening symptoms was highlighted with an average of 56.86 years in the case of SIRS, 60.37 years in the sepsis group, 69.03 years in the septic shock, and 71.04 years in the case of deceased patients (p < 0.04). A statistically significant association between PCT and complex scores (SOFA, CCI and qSOFA) with the evolution of urosepsis was highlighted. Increased hospitalization costs can be observed in the case of deceased patients and those with septic shock and statistically significantly lower in the case of those with SIRS. The predictability of discriminating urosepsis stages was assessed by using the area under the ROC curve (AUC) and very good specificity and sensitivity was identified in predicting the risk of death for PCT (69.57%, 77.33%), the SOFA (91.33%, 76.82%), qSOFA (91.30%, 74.17%) scores, and CCI (65.22%, 88.74%). The AUC value was best for qSOFA (90.3%). For the SIRS group, the PCT (specificity 91.30%, sensitivity 85.71%) and SOFA (specificity 84.78%, sensitivity 78.74%), qSOFA scores (specificity 84.78%, sensitivity 76, 34%) proved to be relevant in establishing the diagnosis. In the case of the septic shock group, the qSOFA (specificity 92.5%, sensitivity 82.71%) and SOFA (specificity 97.5%, sensitivity 77.44%) as well as PCT (specificity 80%, sensitivity 85.61%) are statistically significant disease-defining variables. An important deficit in the tools needed to classify patients into the sepsis group is obvious. All the variables have an increased specificity but a low sensitivity. This translates into a risk of a false negative diagnosis. Conclusions: Although SOFA and qSOFA scores adequately describe patients with septic shock and they are independent prognostic predictors of mortality, they fail to be accurate in diagnosing sepsis. These scores should not replace the conventional triage protocol. In our study, PCT proved to be a disease-defining marker and an independent prognostic predictor of mortality. Patients with important comorbidities, CCI greater than 10, should be treated more aggressively because of increased mortality. Full article

SeptiCyte^® RAPID is a gene expression assay measuring the relative expression levels of host response genes PLA2G7 and PLAC8, indicative of a dysregulated immune response during sepsis. As severe forms of COVID-19 may be considered viral sepsis, we evaluated SeptiCyte RAPID in a series of 94 patients admitted to Foch Hospital (Suresnes, France) with proven SARS-CoV-2 infection. EDTA blood was collected in the emergency department (ED) in 67 cases, in the intensive care unit (ICU) in 23 cases and in conventional units in 4 cases. SeptiScore (0–15 scale) increased with COVID-19 severity. Patients in ICU had the highest SeptiScores, producing values comparable to 8 patients with culture-confirmed bacterial sepsis. Receiver operating characteristic (ROC) curve analysis had an area under the curve (AUC) of 0.81 for discriminating patients requiring ICU admission from patients who were immediately discharged or from patients requiring hospitalization in conventional units. SeptiScores increased with the extent of the lung injury. For 68 patients, a chest computed tomography (CT) scan was performed within 24 h of COVID-19 diagnosis. SeptiScore >7 suggested lung injury ≥50% (AUC = 0.86). SeptiCyte RAPID was compared to other biomarkers for discriminating Critical + Severe COVID-19 in ICU, versus Moderate + Mild COVID-19 not in ICU. The mean AUC for SeptiCyte RAPID was superior to that of any individual biomarker or combination thereof. In contrast to C-reactive protein (CRP), correlation of SeptiScore with lung injury was not impacted by treatment with anti-inflammatory agents. SeptiCyte RAPID can be a useful tool to identify patients with severe forms of COVID-19 in ED, as well as during follow-up. Full article