mNGS vs Culture Critically Ill Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: blood mNGS (IDSeqTM Ultra); blood Culture

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.

• Study Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Nanjing Zhong-Da Hospital
      • Contact: Ling Liu, MD.; Phone Number: 86-25-83272201; Email: liulingdoctor@126.com
      • Contact: Haibo Qiu, PhD.,MD.; Phone Number: 86-25-83272200; Email: haiboq2000@yahoo.com.cn
      • Principal Investigator: Ling Liu, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with sepsis and suspected bloodstream infection

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis; All enrolled patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference between the positive rate of metagenomic full capture technology and the Category of Clinical Impact	Positive, Negative，None and Indeterminate	28 day
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
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
Length of stay	ICU and hospital length of stay	During hospitalization
Anti-infective treatment adjustment	each Anti-infective treatment adjustment	28 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathogen	all the detect pathogens from mNGS and blood culture	28 day
secondary infection	infection secondary to the primary infection	28 day

Collaborators and Investigators

• Sponsor: Southeast University, China
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Northern Jiangsu Province People's Hospital
• Investigators: Study Director: Haibo Qiu, MD, Southeast University, China

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: next- generation sequencing； blood culture；IDSeqTM Ultra
• Other Study ID Numbers: 20181127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No