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

NCT04178382 | Unknown

• 1 other identifier: 2019-195-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis

Keywords

rapid diagnosis; severe pneumonia

Outcome Measures

Primary Outcomes (7)

• mortality

  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.

  up to 28 days after hospitalized.

• the duration of intensive care unit

  time for patients treatment in intensive care unit is patient total treated days in intensive care unit.

  Up to 8 weeks

• the length of hospital stay

  time for patients treatment in hospital is patient total treated days in hosiptal. Index of treat effective and severity of disease.

  Up to 8 weeks

• the day of mechanical ventilation

  time for patients need mechanical ventilation is the total days that patient need mechanical ventilation.

  Up to 8 weeks

• the duration of septic shock

  The more severity patients had a long time during septic shock

  up to 8 weeks

• the incidence of antibiotic-associated diarrhea

  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.

  up to 8 weeks

• the incidence of new multi-drug resistant bacteria colonization or infection

  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.

  up to 8 weeks.

Study Arms (2)

experiment group

EXPERIMENTAL

Combined detection of PCR and CRISPR/Cas12a in alveolar lavage fluid to guide early target adjustment of antibiotics

Diagnostic Test: PCR-CRISPR／Cas12a detection

control group

NO INTERVENTION

Guide the target adjustment of antibiotics according to traditional microbiological detection methods

Interventions

PCR-CRISPR／Cas12a detection DIAGNOSTIC_TEST

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.

experiment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

The Affliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (5)

• Almirall J, Bolibar I, Vidal J, Sauca G, Coll P, Niklasson B, Bartolome M, Balanzo X. Epidemiology of community-acquired pneumonia in adults: a population-based study. Eur Respir J. 2000 Apr;15(4):757-63. doi: 10.1034/j.1399-3003.2000.15d21.x.

  PMID: 10780770 RESULT

• Pletz MW, Wellinghausen N, Welte T. Will polymerase chain reaction (PCR)-based diagnostics improve outcome in septic patients? A clinical view. Intensive Care Med. 2011 Jul;37(7):1069-76. doi: 10.1007/s00134-011-2245-x. Epub 2011 May 15.

  PMID: 21573947 RESULT

• Langelier C, Zinter MS, Kalantar K, Yanik GA, Christenson S, O'Donovan B, White C, Wilson M, Sapru A, Dvorak CC, Miller S, Chiu CY, DeRisi JL. Metagenomic Sequencing Detects Respiratory Pathogens in Hematopoietic Cellular Transplant Patients. Am J Respir Crit Care Med. 2018 Feb 15;197(4):524-528. doi: 10.1164/rccm.201706-1097LE. No abstract available.

  PMID: 28686513 RESULT

• Kuti EL, Patel AA, Coleman CI. Impact of inappropriate antibiotic therapy on mortality in patients with ventilator-associated pneumonia and blood stream infection: a meta-analysis. J Crit Care. 2008 Mar;23(1):91-100. doi: 10.1016/j.jcrc.2007.08.007.

  PMID: 18359426 RESULT

• Wang Y, Liang X, Jiang Y, Dong D, Zhang C, Song T, Chen M, You Y, Liu H, Ge M, Dai H, Xi F, Zhou W, Chen JQ, Wang Q, Chen Q, Yu W. Novel fast pathogen diagnosis method for severe pneumonia patients in the intensive care unit: randomized clinical trial. Elife. 2022 Oct 7;11:e79014. doi: 10.7554/eLife.79014.

  PMID: 36205312 DERIVED

MeSH Terms

Conditions

Sepsis; Pneumonia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• kui w yu, phd

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

yan wang, MD

CONTACT

+86-025-83106666-40400; yudrnj2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 26, 2019
• Study Start: August 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)