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Effect of PCR-CRISPR/Cas12a on the Early Anti-infective Schemes in Patients With Open Air Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178382
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Chinese Medical Association

Brief Summary:
This study is a multicenter randomized controlled trial. The purpose of this study is to assess the efficacy of the combination of PCR and CRISPR/Cas12a in alveolar lavage fluid for early targeted anti-infective therapy for patients with severe pneumonia. Hosted by the Department of Critical Care Medicine, Affiliated Drum Tower Hospital of Nanjing University Medical College, 5 adult ICU units participate in 3 hospitals. All patients are randomly assigned to the experimental group and the control group. For experimental group, the combined detection of PCR and CRISPR/Cas12a in the alveolar lavage fluid was carried out in the early stage, and the antibiotic scheme is changed base on the results of PCR-CRISPR/Cas12a.The patients in the control group were adjusted according to the traditional microbial detection methods. The types of early antibiotics, the proportion of target antibiotics, the duration of anti-infective treatment, the length of hospital stay in ICU, the mortality rate, the secondary antibiotic-associated diarrhea, and the incidence of new multidrug-resistant infections were recorded.

Condition or disease Intervention/treatment Phase
Severe Sepsis Diagnostic Test: PCR-CRISPR/Cas12a detection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of PCR-CRISPR/Cas12a on the Early Anti-infective Schemes in Patients With Open Air Pneumonia
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: experiment group
Combined detection of PCR and CRISPR/Cas12a in alveolar lavage fluid to guide early target adjustment of antibiotics
Diagnostic Test: PCR-CRISPR/Cas12a detection
Evaluate whether the combination of PCR and CRISPR/Cas12a detection of alveolar lavage fluid changes the choice of early antibiotics in patients with pneumonia in artificial airways, and whether it changes the prognosis compared with traditional pathogenic microbial detection techniques.

No Intervention: control group
Guide the target adjustment of antibiotics according to traditional microbiological detection methods



Primary Outcome Measures :
  1. mortality [ Time Frame: up to 28 days after hospitalized. ]
    The patient's 28-day mortality rate is the survival rate from the onset to the disease at 28 days, compared with the total number of illnesses, to assess the severity of the disease.

  2. the duration of intensive care unit [ Time Frame: Up to 8 weeks ]
    time for patients treatment in intensive care unit is patient total treated days in intensive care unit.

  3. the length of hospital stay [ Time Frame: Up to 8 weeks ]
    time for patients treatment in hospital is patient total treated days in hosiptal. Index of treat effective and severity of disease.

  4. the day of mechanical ventilation [ Time Frame: Up to 8 weeks ]
    time for patients need mechanical ventilation is the total days that patient need mechanical ventilation.

  5. the duration of septic shock [ Time Frame: up to 8 weeks ]
    The more severity patients had a long time during septic shock

  6. the incidence of antibiotic-associated diarrhea [ Time Frame: up to 8 weeks ]
    The incidence of antibiotic-associated diarrhea is the index of side effects of anti-infective treatment. The time frame started after the use of antibiotics, during the total hospitalized.

  7. the incidence of new multi-drug resistant bacteria colonization or infection [ Time Frame: up to 8 weeks. ]
    rate of multi-drug resistant bacteria colonization or infection is the index of side effects of anti-infective treatment. The time frame started after the use of antibiotics, during the total hospitalized.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • patients with artificial airway and expected artificial airway for more than 48 hours
  • patients with suspected pneumonia or clear pneumonia
  • signed informed consent
  • expected ICU hospitalization more than 3 days.

Exclusion Criteria:

  • pregnant women
  • lactating women
  • considered by the doctors for bronchoscopy moderate to severe asthma
  • airway stenosis
  • tracheal fistula, bronchopleural fistula
  • expected to die or give up treatment within 72 hours
  • participate in other clinical research

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): NCT04178382


Contacts
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Contact: yan wang, MD +86-025-83106666-40400 yudrnj2@163.com

Locations
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China, Jiangsu
The Affliated Drum Tower Hospital, Medical School of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Wenkui Yu    02568182222 ext 60506    yudrnj@163.com   
Sponsors and Collaborators
Chinese Medical Association
Investigators
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Study Chair: kui w yu, phd The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications of Results:
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Responsible Party: Chinese Medical Association
ClinicalTrials.gov Identifier: NCT04178382    
Other Study ID Numbers: 2019-195-01
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Chinese Medical Association:
rapid diagnosis
severe pneumonia
Additional relevant MeSH terms:
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Sepsis
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents