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Comparison of mNGS and Culture to Detect Microbe in Critically Infected Patients and Modification to Anti-infection Treatment and Outcome

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ClinicalTrials.gov Identifier: NCT03760315
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Ling Liu, Southeast University, China

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. This study is to evaluate whether the mNGS can detect microbe ,guide antibiotics use and improve outcome.

Condition or disease Intervention/treatment
Sepsis, Severe Diagnostic Test: mNGS (Next-Generation Sequencing Technology); Culture

Detailed Description:
patients in our ICU were took Culture sample and mNGS (diagnosis of Sepsis with Cell-free DNA by Next-Generation Sequencing Technology)sample. Clinicians use their knowledge and experience to decide antibiotics use with the guide of Culture results or mNGS results. According to the way of guide, the researcher divide patients into (1)mNGS targeted group , (2)Culture targeted group and (3)Experience group. First evaluate how much can mNGS guide clinical antibiotics use. Secondly to evaluate the time consuming and accuracy between the mNGS and Culture methods. Finally, to compare the clinical outcome, microbiologic outcome and survival rate antibiotics and so on between the groups.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
targeted treatment by mNGS
In the mNGS targeted treatment group,Clinicians figure out sepsis patients' microbe by mNGS and alter or confirm targeted treatment.
Diagnostic Test: mNGS (Next-Generation Sequencing Technology); Culture
mNGS and Culture of microbe in sepsis patients

targeted treatment by Culture
In the Culture targeted treatment group,Clinicians figure out sepsis patients' microbe by Culture and alter or confirm targeted treatment.
Diagnostic Test: mNGS (Next-Generation Sequencing Technology); Culture
mNGS and Culture of microbe in sepsis patients

Experience treatment
In the experience treatment group,Clinicians didn't figure out sepsis patients' microbe even with Culture and mNGS of the plasm and other secretion to alter or confirm targeted treatment.
Diagnostic Test: mNGS (Next-Generation Sequencing Technology); Culture
mNGS and Culture of microbe in sepsis patients




Primary Outcome Measures :
  1. By mNGS/Culture Targeted antibiotics treatment [ Time Frame: May,1,2017-May,1,2020 ]
    According to how clinician recognize etiologic microbes and decides antibiotics by mNGS or Culture, patients are divided into different group . The parameter is to describe the patients percentage in different groups.


Secondary Outcome Measures :
  1. antibiotics duration [ Time Frame: May,1,2017-May,1,2020 ]
    The duration from the start use of antibiotics to the end

  2. clinical outcome [ Time Frame: May,1,2017-May,1,2020 ]
    clinical cure :Resolution of clinical signs and symptoms. no requirement for additional antibacterial treatment 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

  3. microbiologic outcome [ Time Frame: May,1,2017-May,1,2020 ]
    categorical variable 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

  4. Hospital / ICU survival [ Time Frame: May,1,2017-May,1,2020 ]
    the survival rate(survival/total) during hospital stay or ICU stay

  5. Hospital/ICU stay [ Time Frame: May,1,2017-May,1,2020 ]
    The duration from the admission to leave or death


Other Outcome Measures:
  1. Hospital /ICU coverage [ Time Frame: May,1,2017-May,1,2020 ]
    The fee from the the admission to leave or death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with sepsis and suspected infective focus receiving mNGS and Culture test to detect microbes
Criteria

Inclusion Criteria:

Age < 18years Sepsis

Exclusion Criteria:

refuse to participate


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760315


Contacts
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Contact: ling liu, MD 13851435472 liulingdoctor@126.com

Locations
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China, Jiangsu
Nanjing Zhong-Da Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Ling Liu, MD.    86-25-83272201    liulingdoctor@126.com   
Contact: Haibo Qiu, PhD.,MD.    86-25-83272200    haiboq2000@yahoo.com.cn   
Principal Investigator: Ling Liu, MD.         
Sponsors and Collaborators
Southeast University, China
Investigators
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Study Director: Haibo Qiu, MD Southeast University, China

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Responsible Party: Ling Liu, Director, Southeast University, China
ClinicalTrials.gov Identifier: NCT03760315     History of Changes
Other Study ID Numbers: 20181127
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ling Liu, Southeast University, China:
next- generation sequencing; microbe

Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes