Severe Sepsis Clinical Trial
Official title:
Effect of PCR-CRISPR/Cas12a on the Early Anti-infective Schemes in Patients With Open Air Pneumonia
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.
Status | Recruiting |
Enrollment | 146 |
Est. completion date | August 30, 2020 |
Est. primary completion date | July 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | The Affliated Drum Tower Hospital, Medical School of Nanjing University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Chinese Medical Association |
China,
Almirall J, Bolíbar I, Vidal J, Sauca G, Coll P, Niklasson B, Bartolomé M, Balanzó X. Epidemiology of community-acquired pneumonia in adults: a population-based study. Eur Respir J. 2000 Apr;15(4):757-63. — View Citation
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. — View Citation
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 — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | |
Primary | 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 | |
Primary | the day of mechanical ventilation | time for patients need mechanical ventilation is the total days that patient need mechanical ventilation. | Up to 8 weeks | |
Primary | the duration of septic shock | The more severity patients had a long time during septic shock | up to 8 weeks | |
Primary | 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 | |
Primary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04804306 -
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
|
||
Completed |
NCT04227652 -
Control of Fever in Septic Patients
|
N/A | |
Recruiting |
NCT04005001 -
Machine Learning Sepsis Alert Notification Using Clinical Data
|
Phase 2 | |
Recruiting |
NCT02899143 -
Short-course Antimicrobial Therapy in Sepsis
|
Phase 2 | |
Completed |
NCT02539147 -
Characterization of Non-canonical Way in Inflammasome Monocytes of Patients With Severe Sepsis
|
N/A | |
Completed |
NCT01929772 -
German Lactat Clearance in Severe Sepsis
|
N/A | |
Completed |
NCT01932814 -
Acute Kidney Injury in Septic Critically Ill Patients : Are Aminoglycosides Really Harmful?
|
N/A | |
Completed |
NCT01449721 -
Preemptive Resuscitation for Eradication of Septic Shock
|
N/A | |
Active, not recruiting |
NCT01162109 -
Zinc Therapy in Critical Illness
|
Phase 1 | |
Not yet recruiting |
NCT01211899 -
4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 Gene and Disseminated Intravascular Coagulation in Severe Sepsis and Septic Shock
|
N/A | |
Completed |
NCT00934011 -
Use of Inflammatory Biomarkers to Guide Antibiotic Therapy in Patients With Severe Infections
|
N/A | |
Recruiting |
NCT00335907 -
Protocol-driven Hemodynamic Support for Patients With Septic Shock
|
N/A | |
Completed |
NCT00463645 -
Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients
|
N/A | |
Completed |
NCT02361528 -
GM-CSF to Decrease ICU Acquired Infections
|
Phase 3 | |
Completed |
NCT02734550 -
(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis
|
N/A | |
Completed |
NCT02973243 -
The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III
|
N/A | |
Terminated |
NCT03895853 -
Early Metabolic Resuscitation for Septic Shock
|
Phase 2 | |
Completed |
NCT01945983 -
Early Use of Norepinephrine in Septic Shock Resuscitation
|
N/A | |
Completed |
NCT01598831 -
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
|
Phase 3 | |
Enrolling by invitation |
NCT02258984 -
Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial
|
N/A |