mNGS vs Culture Critically Ill Patients

Sepsis Clinical Trial

Official title:

Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03760315
• Other study ID #: 20181127
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2022
• Source: Southeast University, China
• Contact: ling liu, MD
• Phone: 13851435472
• Email: liulingdoctor[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Sepsis

Intervention

Diagnostic Test:
• blood mNGS (IDSeqTM Ultra); blood Culture
take blood samples for mNGS and Culture at the same time in sepsis patients. No intervention on the treatment of the patients.

Locations

Country	Name	City	State
China	Nanjing Zhong-Da Hospital	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Southeast University, China	Northern Jiangsu Province People's Hospital, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pathogen	all the detect pathogens from mNGS and blood culture	28 day
Other	secondary infection	infection secondary to the primary infection	28 day
Primary	difference of positive rate between mNGS and Culture	The difference between the positive rate of mNGS and the positive rate of blood culture.	28 day
Secondary	The difference between the positive rate of metagenomic full capture technology and the Category of Clinical Impact	Positive, Negative,None and Indeterminate	28 day
Secondary	Change of SOFA	change of SOFA score (include each organ) at baseline, day 3 and day 7 clinical improvement :Improvement in 2 or more clinical signs and symptoms no requirement for additional antibacterial treatment Clinical failure:Persistence or progression of baseline signs and symptoms	7 day
Secondary	Mortality	28 day,ICU and hospital mortality Documented microbiologic eradication:Absence of primary microbe from infection site Presumed microbiologic eradication:Clinical cure without available microbiologic culture data Presumed microbiologic persistence:Clinical failure in the absence of any microbiologic data Documented microbiologic persistence:Continued presence of MRSA based on microbiologic culture Superinfection: Clinical failure and isolation of a pathogen not present at baseline at the original infection site	During hospitalization
Secondary	Length of stay	ICU and hospital length of stay	During hospitalization
Secondary	Anti-infective treatment adjustment	each Anti-infective treatment adjustment	28 day