Next-generation sequencing diagnostics of bacteremia in pediatric sepsis
Sepsis and septic shock are the most severe forms of infection affecting predominantly elderly people, preterm and term neonates, and young infants. Even in high-income countries sepsis causes about 8% of admissions to pediatric intensive care units (PICUs). Early diagnosis, rapid anti-infective tre...
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Published in | Medicine (Baltimore) Vol. 100; no. 25; p. e26403 |
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Main Authors | , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Lippincott Williams & Wilkins
25.06.2021
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Abstract | Sepsis and septic shock are the most severe forms of infection affecting predominantly elderly people, preterm and term neonates, and young infants. Even in high-income countries sepsis causes about 8% of admissions to pediatric intensive care units (PICUs). Early diagnosis, rapid anti-infective treatment, and prompt hemodynamic stabilization are crucial for patient survival. In this context, it is essential to identify the causative pathogen as soon as possible to optimize antimicrobial treatment. To date, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care. However, they have 2 major problems: on the one hand, in the case of very small sample volumes (and thus usually in children), they are not sufficiently sensitive. On the other hand, with a time-to-result of 2 to 5 days, blood cultures need a relatively long time for the anti-infective therapy to be calculated. To overcome these problems, culture-independent molecular diagnostic procedures such as unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) have been tested successfully in adult septic patients. However, these results still need to be transferred to the pediatric setting.
The Next GeneSiPS-Trial is a prospective, observational, non-interventional, multicenter study used to assess the diagnostic performance of an NGS-based approach for the identification of causative pathogens in (preterm and term) neonates (d1-d28, n = 50), infants (d29 to <1 yr, n = 50), and toddlers (1 yr to <5 yr, n = 50) with suspected or proven severe sepsis or septic shock (according to the pediatric sepsis definition) by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard of care (culture-based) microbiological diagnostics. Potential changes in anti-infective treatment regimens based on these NGS results will be estimated retrospectively by a panel of 3 independent clinical specialists.
Neonates, infants, and young children are significantly affected by sepsis. Fast and more sensitive diagnostic approaches are urgently needed. This prospective, observational, non-interventional, multicenter study seeks to evaluate an NGS-based approach in critically ill children suffering from sepsis.
DRKS-ID: DRKS00015705 (registered October 24, 2018). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015705. |
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AbstractList | Sepsis and septic shock are the most severe forms of infection affecting predominantly elderly people, preterm and term neonates, and young infants. Even in high-income countries sepsis causes about 8% of admissions to pediatric intensive care units (PICUs). Early diagnosis, rapid anti-infective treatment, and prompt hemodynamic stabilization are crucial for patient survival. In this context, it is essential to identify the causative pathogen as soon as possible to optimize antimicrobial treatment. To date, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care. However, they have 2 major problems: on the one hand, in the case of very small sample volumes (and thus usually in children), they are not sufficiently sensitive. On the other hand, with a time-to-result of 2 to 5 days, blood cultures need a relatively long time for the anti-infective therapy to be calculated. To overcome these problems, culture-independent molecular diagnostic procedures such as unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) have been tested successfully in adult septic patients. However, these results still need to be transferred to the pediatric setting.INTRODUCTIONSepsis and septic shock are the most severe forms of infection affecting predominantly elderly people, preterm and term neonates, and young infants. Even in high-income countries sepsis causes about 8% of admissions to pediatric intensive care units (PICUs). Early diagnosis, rapid anti-infective treatment, and prompt hemodynamic stabilization are crucial for patient survival. In this context, it is essential to identify the causative pathogen as soon as possible to optimize antimicrobial treatment. To date, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care. However, they have 2 major problems: on the one hand, in the case of very small sample volumes (and thus usually in children), they are not sufficiently sensitive. On the other hand, with a time-to-result of 2 to 5 days, blood cultures need a relatively long time for the anti-infective therapy to be calculated. To overcome these problems, culture-independent molecular diagnostic procedures such as unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) have been tested successfully in adult septic patients. However, these results still need to be transferred to the pediatric setting.The Next GeneSiPS-Trial is a prospective, observational, non-interventional, multicenter study used to assess the diagnostic performance of an NGS-based approach for the identification of causative pathogens in (preterm and term) neonates (d1-d28, n = 50), infants (d29 to <1 yr, n = 50), and toddlers (1 yr to <5 yr, n = 50) with suspected or proven severe sepsis or septic shock (according to the pediatric sepsis definition) by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard of care (culture-based) microbiological diagnostics. Potential changes in anti-infective treatment regimens based on these NGS results will be estimated retrospectively by a panel of 3 independent clinical specialists.METHODSThe Next GeneSiPS-Trial is a prospective, observational, non-interventional, multicenter study used to assess the diagnostic performance of an NGS-based approach for the identification of causative pathogens in (preterm and term) neonates (d1-d28, n = 50), infants (d29 to <1 yr, n = 50), and toddlers (1 yr to <5 yr, n = 50) with suspected or proven severe sepsis or septic shock (according to the pediatric sepsis definition) by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard of care (culture-based) microbiological diagnostics. Potential changes in anti-infective treatment regimens based on these NGS results will be estimated retrospectively by a panel of 3 independent clinical specialists.Neonates, infants, and young children are significantly affected by sepsis. Fast and more sensitive diagnostic approaches are urgently needed. This prospective, observational, non-interventional, multicenter study seeks to evaluate an NGS-based approach in critically ill children suffering from sepsis.DISCUSSIONNeonates, infants, and young children are significantly affected by sepsis. Fast and more sensitive diagnostic approaches are urgently needed. This prospective, observational, non-interventional, multicenter study seeks to evaluate an NGS-based approach in critically ill children suffering from sepsis.DRKS-ID: DRKS00015705 (registered October 24, 2018). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015705.TRIAL REGISTRATIONDRKS-ID: DRKS00015705 (registered October 24, 2018). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015705. Abstract Introduction: Sepsis and septic shock are the most severe forms of infection affecting predominantly elderly people, preterm and term neonates, and young infants. Even in high-income countries sepsis causes about 8% of admissions to pediatric intensive care units (PICUs). Early diagnosis, rapid anti-infective treatment, and prompt hemodynamic stabilization are crucial for patient survival. In this context, it is essential to identify the causative pathogen as soon as possible to optimize antimicrobial treatment. To date, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care. However, they have 2 major problems: on the one hand, in the case of very small sample volumes (and thus usually in children), they are not sufficiently sensitive. On the other hand, with a time-to-result of 2 to 5 days, blood cultures need a relatively long time for the anti-infective therapy to be calculated. To overcome these problems, culture-independent molecular diagnostic procedures such as unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) have been tested successfully in adult septic patients. However, these results still need to be transferred to the pediatric setting. Methods: The Next GeneSiPS-Trial is a prospective, observational, non-interventional, multicenter study used to assess the diagnostic performance of an NGS-based approach for the identification of causative pathogens in (preterm and term) neonates (d1–d28, n = 50), infants (d29 to <1 yr, n = 50), and toddlers (1 yr to <5 yr, n = 50) with suspected or proven severe sepsis or septic shock (according to the pediatric sepsis definition) by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard of care (culture-based) microbiological diagnostics. Potential changes in anti-infective treatment regimens based on these NGS results will be estimated retrospectively by a panel of 3 independent clinical specialists. Discussion: Neonates, infants, and young children are significantly affected by sepsis. Fast and more sensitive diagnostic approaches are urgently needed. This prospective, observational, non-interventional, multicenter study seeks to evaluate an NGS-based approach in critically ill children suffering from sepsis. Trial registration: DRKS-ID: DRKS00015705 (registered October 24, 2018). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015705 Sepsis and septic shock are the most severe forms of infection affecting predominantly elderly people, preterm and term neonates, and young infants. Even in high-income countries sepsis causes about 8% of admissions to pediatric intensive care units (PICUs). Early diagnosis, rapid anti-infective treatment, and prompt hemodynamic stabilization are crucial for patient survival. In this context, it is essential to identify the causative pathogen as soon as possible to optimize antimicrobial treatment. To date, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care. However, they have 2 major problems: on the one hand, in the case of very small sample volumes (and thus usually in children), they are not sufficiently sensitive. On the other hand, with a time-to-result of 2 to 5 days, blood cultures need a relatively long time for the anti-infective therapy to be calculated. To overcome these problems, culture-independent molecular diagnostic procedures such as unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) have been tested successfully in adult septic patients. However, these results still need to be transferred to the pediatric setting. The Next GeneSiPS-Trial is a prospective, observational, non-interventional, multicenter study used to assess the diagnostic performance of an NGS-based approach for the identification of causative pathogens in (preterm and term) neonates (d1-d28, n = 50), infants (d29 to <1 yr, n = 50), and toddlers (1 yr to <5 yr, n = 50) with suspected or proven severe sepsis or septic shock (according to the pediatric sepsis definition) by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard of care (culture-based) microbiological diagnostics. Potential changes in anti-infective treatment regimens based on these NGS results will be estimated retrospectively by a panel of 3 independent clinical specialists. Neonates, infants, and young children are significantly affected by sepsis. Fast and more sensitive diagnostic approaches are urgently needed. This prospective, observational, non-interventional, multicenter study seeks to evaluate an NGS-based approach in critically ill children suffering from sepsis. DRKS-ID: DRKS00015705 (registered October 24, 2018). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015705. |
Author | Luntz, Steffen Brenner, Thorsten Klose, Christina Skolik, Caroline Weigand, Markus A Schmoch, Thomas Westhoff, Jens H Decker, Sebastian O Hoffmann, Georg F Sohn, Kai Bruckner, Thomas Felderhoff-Müser, Ursula Skarabis, Annabell Feisst, Manuel Dohna-Schwake, Christian |
AuthorAffiliation | a Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen d Department of Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, University Duisburg-Essen, Essen f Coordination Centre for Clinical Trials (KKS), Ruprecht-Karls-University, Heidelberg c Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg g Fraunhofer Institute for Interfacial Engineering and Biotechnology, Stuttgart, Germany b Department of Anesthesiology, Heidelberg University Hospital e Institute of Medical Biometry, University of Heidelberg |
AuthorAffiliation_xml | – name: e Institute of Medical Biometry, University of Heidelberg – name: a Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen – name: c Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg – name: b Department of Anesthesiology, Heidelberg University Hospital – name: f Coordination Centre for Clinical Trials (KKS), Ruprecht-Karls-University, Heidelberg – name: d Department of Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, University Duisburg-Essen, Essen – name: g Fraunhofer Institute for Interfacial Engineering and Biotechnology, Stuttgart, Germany |
Author_xml | – sequence: 1 givenname: Thomas surname: Schmoch fullname: Schmoch, Thomas organization: Department of Anesthesiology, Heidelberg University Hospital – sequence: 2 givenname: Jens H surname: Westhoff fullname: Westhoff, Jens H organization: Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg – sequence: 3 givenname: Sebastian O surname: Decker fullname: Decker, Sebastian O organization: Department of Anesthesiology, Heidelberg University Hospital – sequence: 4 givenname: Annabell surname: Skarabis fullname: Skarabis, Annabell organization: Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen – sequence: 5 givenname: Georg F surname: Hoffmann fullname: Hoffmann, Georg F organization: Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg – sequence: 6 givenname: Christian surname: Dohna-Schwake fullname: Dohna-Schwake, Christian organization: Department of Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, University Duisburg-Essen, Essen – sequence: 7 givenname: Ursula surname: Felderhoff-Müser fullname: Felderhoff-Müser, Ursula organization: Department of Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, University Duisburg-Essen, Essen – sequence: 8 givenname: Caroline surname: Skolik fullname: Skolik, Caroline organization: Institute of Medical Biometry, University of Heidelberg – sequence: 9 givenname: Manuel surname: Feisst fullname: Feisst, Manuel organization: Institute of Medical Biometry, University of Heidelberg – sequence: 10 givenname: Christina surname: Klose fullname: Klose, Christina organization: Institute of Medical Biometry, University of Heidelberg – sequence: 11 givenname: Thomas surname: Bruckner fullname: Bruckner, Thomas organization: Institute of Medical Biometry, University of Heidelberg – sequence: 12 givenname: Steffen surname: Luntz fullname: Luntz, Steffen organization: Coordination Centre for Clinical Trials (KKS), Ruprecht-Karls-University, Heidelberg – sequence: 13 givenname: Markus A surname: Weigand fullname: Weigand, Markus A organization: Department of Anesthesiology, Heidelberg University Hospital – sequence: 14 givenname: Kai surname: Sohn fullname: Sohn, Kai organization: Fraunhofer Institute for Interfacial Engineering and Biotechnology, Stuttgart, Germany – sequence: 15 givenname: Thorsten surname: Brenner fullname: Brenner, Thorsten organization: Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen |
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Snippet | Sepsis and septic shock are the most severe forms of infection affecting predominantly elderly people, preterm and term neonates, and young infants. Even in... Abstract Introduction: Sepsis and septic shock are the most severe forms of infection affecting predominantly elderly people, preterm and term neonates, and... |
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SubjectTerms | Anti-Bacterial Agents - therapeutic use Bacteremia - diagnosis Bacteremia - drug therapy Bacteremia - microbiology Bacteria - genetics Bacteria - isolation & purification Blood Culture Child, Preschool DNA, Bacterial - isolation & purification Early Diagnosis Female High-Throughput Nucleotide Sequencing Humans Infant Infant, Newborn Intensive Care Units, Pediatric Male Molecular Diagnostic Techniques - methods Multicenter Studies as Topic Observational Studies as Topic Prospective Studies Retrospective Studies Severity of Illness Index Shock, Septic - blood Shock, Septic - diagnosis Shock, Septic - drug therapy Shock, Septic - microbiology Study Protocol Clinical Trial |
Title | Next-generation sequencing diagnostics of bacteremia in pediatric sepsis |
URI | https://www.ncbi.nlm.nih.gov/pubmed/34160425 https://www.proquest.com/docview/2544459209/abstract/ https://pubmed.ncbi.nlm.nih.gov/PMC8238315 |
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