An observational study in Pneumonia, Acute Pyelonephritis and Bacteremia, sponsored by Hellenic Institute for the Study of Sepsis. Completed at 4 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by Hellenic Institute for the Study of Sepsis · Observational
Rapid detection of microorganisms is a promising approach towards early administration of appropriate antibiotics for sepsis. This study aims to investigate the potential of a new NGS platform for the rapid diagnosis of circulating bacteria in blood.
Early start of antimicrobials is the cornerstone of management of critically ill patients. The appropriate time window for this early intervention may vary greatly, but it is considered to be one to 3 hours from hospital admission. However, the choice of the antimicrobials for early intervention relies on empirical selection and may several times be inappropriate due to the emergence of antimicrobial resistance. The only way to overcome this difficulty is guidance through early microbial identification and antibiotic susceptibility testing (AST). However, blood cultures are positive in almost 20% of critically ill patients and AST may delay as much as 72 hours.
This means that another type of approach is warranted which will tackle the major limitation of standard-of-care (SoC) microbiology, namely, the need to incubate whole blood into flasks enriched with growth media which necessitates subculturing once a blood flask turns positive. It is evident that rapid identification of the pathogen followed by AST using whole blood without the need of blood culture can be a major advance in the diagnostic field.
The present study is based on previous analysis of ethylenediaminetetraacetic acid (EDTA) whole blood coming from patients with known bloodstream infection. Next generation sequencing (NGS) of bacterial DNA extracted from whole blood managed to identify the correct pathogen. This study is aiming at the validation of this NGS -based assay in a broader number of patients.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's enrollment of 100 is below the median of 252 across 535 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Hellenic Institute for the Study of Sepsis is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
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Patients who meet all inclusion criteria and who do not meet any exclusion criterion will be enrolled in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with high suspicion of infection with at least one sign of the quick Sequential Organ Failure Assessment (qSOFA) score
Diagnostic Test: NGS-based assay for bacterial identification
A total volume of 26ml of whole blood will be sampled from each enrolled patient for three consecutive days. This will be used for Standard-of-Care (SoC) culture and Next Generation Sequencing (NGS), for identification of circulating microorganisms.
The rate of matching between the results of Next Generation Sequencing and the Standard-of-Care culture for patients with sepsis.
This will be done by assessing the sensitivity, the specificity, the positive predictive value and the negative predictive value of Next Generation Sequencing and Standard-of-Care. For the analysis of this diagnostic performance, the results of the SoC cultures will be considered the "gold standard" for comparisons.
Time frame: 7 days
Difference in time to identification of the bacterial pathogen between Next Generation Sequencing and the Standard-of-Care culture
The time from start of incubation until final identification will be recorded and compared between the two methods.
Time frame: 7 days
Difference in time to Antibiotic Susceptibility Testing between Next Generation Sequencing and the Standard-of-Care culture
The time from start of incubation until the Antibiotic Susceptibility Testing will be recorded and compared between the two methods.
Time frame: 7 days
Plan to share: No
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Hellenic Institute for the Study of Sepsis