Clinical trial NCT03760315: mNGS vs Culture Critically Ill Patients
Official title: Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: next- generation sequencing； blood culture；IDSeqTM Ultra
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Northern Jiangsu People's Hospital
First posted: 2018-11-30
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with sepsis and suspected bloodstream infection

Brief summary: mNGS is popular in research and recently it has been used clinically to detect microbes in the blood or other secretion in infected patients for quicker ,broad and accurate detection of microbes. In ICU ,patients are critically ill and need quicker and accurate antibiotics use to stop the pathologic process. The purpose of this study was to determine whether the positive detection rate of pathogens in patients with sepsis by metagenomic full-targeted detection technology was higher than that in blood culture, and to determine whether the pathogens found in patients with sepsis by metagenomic full-targeted detection technology were important for clinical development. Anti-infective regimens can help.

Detailed description: Sepsis patients in ICU were took blood culture sample and blood sample for mNGS test (IDSeqTM Ultra, Combing with Metagenomics and Pathogen/AMR/VF Probe Enrichment). Clinicians use their knowledge and experience to decide antibiotics use with the guide of Culture results or mNGS results. Validation with digital droplet PCR assays when metagenomic full-targeted assays identify pathogens not identified in conventional blood cultures The difference between the positive rate of mNGS and the positive rate of blood culture were recorded. Patient were followed at least 28 days after enrollment or an outcome indicator. Possible scenarios for detecting clinical impact were detected. Etiology, biochemical indicators, immune function, infection indicator, secondary infection, SOFA score and length of stay，outcome were recorded.

Eligibility criteria: Inclusion Criteria:

Age \> 18years admit to ICU Meet the Sepsis 3.0 diagnostic criteria and suspected bloodstream infection, and the diagnosis of Sepsis ≤ 24 hours; Estimated ICU stay ≥ 24 hours; Informed consent;

Exclusion Criteria:

Severe organ dysfunction, expected death within 72 hours; Receive palliative care; Refuse to participate;

Primary outcomes:
measure: difference of positive rate between mNGS and Culture
timeFrame: 28 day
Secondary outcomes:
measure: The difference between the positive rate of metagenomic full capture technology and the Category of Clinical Impact
timeFrame: 28 day
measure: Change of SOFA
timeFrame: 7 day
measure: Mortality
timeFrame: During hospitalization
measure: Length of stay
timeFrame: During hospitalization
measure: Anti-infective treatment adjustment
timeFrame: 28 day
Other outcomes:
measure: pathogen
timeFrame: 28 day
measure: secondary infection
timeFrame: 28 day
Locations:
city: Nanjing
country: China
facility: Nanjing Zhong-Da Hospital
state: Jiangsu
Study officials:
affiliation: Southeast University, China
name: Haibo Qiu, MD
role: STUDY_DIRECTOR
References: