Disease: Pneumonia, (NCT04178382)

Disease info:

Pneumonia is an infection of the lungs that can cause mild to severe illness in people of all ages. Viruses, bacteria, and fungi can all cause pneumonia, but the most common causes of viral pneumonia are influenza, respiratory syncytial virus (RSV), and SARS-CoV-2 (the virus that causes COVID-19). A common cause of bacterial pneumonia is Streptococcus pneumoniae (pneumococcus). However, clinicians are not always able to determine which pathogen causes pneumonia in a given patient.

Community-acquired pneumonia occurs when someone develops pneumonia in the community (not in a hospital). Healthcare-associated pneumonia occurs when someone develops pneumonia during or following a stay in a healthcare facility. 

Vaccines can help prevent infection by some of the bacteria and viruses that can cause pneumonia: Haemophilus influenzae type b (Hib), Influenza (flu), Measles, Pertussis (whooping cough), Pneumococcal, Varicella (chickenpox). 

Frequency:
CDC data showed that in the United States during 2017: 3 million people were diagnosed with pneumonia in an emergency department. Approximately 50,000 people died from pneumonia. Most of the people affected by pneumonia in the United States are adults.
Official title:
Effect of PCR-CRISPR-Cas12a on the Early Anti-infective Schemes in Patients With Open Air Pneumonia
Who:

Study Chair: Kui W Yu, PhD  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 

Sponsor:

Chinese Medical Association

Partners:
Locations:

China, Jiangsu

Study start:
Aug. 1, 2020
Enrollment:
146 participants
Method:
CRISPR-Cas12a and PCR (Polymerase Chain Reaction)
Condition:
Pneumonia
Target gene:
Unknown
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT04178382
Other links:

LinkPneumonia Infection Information and FrequencyLinkImpact of inappropriate antibiotic therapy on mortality in patients with ventilator-associated pneumonia and blood stream infection: a meta-analysisLinkNews: Clinical Trial Update – CRISPR-Based Diagnostics for Infectious DiseaseLinkA CRISPR-Cas12a-based specific enhancer for more sensitive detection of SARS-CoV-2 infection

Status: Active recruiting

Description

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.

The PCR-CRISPR/Cas12a combination technology of alveolar lavage fluid developed by the College of Life Sciences of Nanjing University is based on PCR amplification and fluorescence signal detection twice to achieve the detection of the presence and absence of specific DNA sequences in the test sample.

The determination of the detection result of the clinical sample pathogen is based on the comparison of the fluorescence results of the PCR product of the sample DNAD with the fluorescence detection results of the positive control (PC) and the negative control (NC) as a standard. The specific recognition function of the CRISPR/Cas12a system relies on the specific guidance and binding of the crRNA to specific DNA, and the specificity of the crRNA is determined by detection of a positive control of a common pathogen by a single crRNA. The detection technology is highly specific and takes only 2-3 hours, which is a qualitative leap in the detection time compared to the conventional technology.

Last updated: Oct. 28, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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