Pathogen Identification of Bacterial Pneumonia Via DNA Detection

NCT ID: NCT00567827

Last Updated: 2010-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2896 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-12-31

Brief Summary

Pneumonia is a common cause of morbidity and mortality. The diagnosis of pneumonia from the microbiology perspective has been challenging. Recent reports suggest the utility of nuclear acid detection for rapid and accurate diagnoses of these pathogens and their antibiotic-resistant spectrum. Extracted bacterial nucleic acid in sputum specimen will be identified by Nuclear acid detection assay kit with Microfluidic Pumping Chip and LAMP methods

Detailed Description

Sputum specimens normally collected from the patients with pneumonia for routine microbiologic testing and extra specimens will be evaluated via nuclear acid assay developed in our laboratory. The assay will be directed at variety of both pathogens, including Streptococcus pneumoniae, Hemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma pneumonia, Chlamydia pneumoniae and Legionella pneumophila, and common antibiotic-resistant genes, such as ESBLs genes, MecA, OprD. The ultimate goal is to have an available panel of highly accurate and rapid (same day) assay, which will be carried out in several hours for identification.

The extracted pathogen nucleic acid in sputum specimen will be identified by Nuclear acid detection assay with Microfluidic Pumping Chip and LAMP methods. The species of bacteria and their antibiotic-resistant gene to be detected are as listed above. As nucleic acid extracts will be archived, other pathogens can be investigated in the future if the correlated assay is developed. All results obtained by nuclear acid detection will be compared to results for conventional testing as listed above. Sensitivity, specificity and predictive values will be calculated. In cases where discordant results occur, additional testing and or medical history review will be properly conducted.

Conditions

Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Greater than 18 years of age.
• Cough present greater than one day
• History of fever
• X-ray evidence of pneumonia.

Exclusion Criteria

• Pneumonia caused by TB, fungi and virus

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peking University People's Hospital

Principal Investigators

Zhancheng Gao, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

References

Kang Y, Deng R, Wang C, Deng T, Peng P, Cheng X, Wang G, Qian M, Gao H, Han B, Chen Y, Hu Y, Geng R, Hu C, Zhang W, Yang J, Wan H, Yu Q, Wei L, Li J, Tian G, Wang Q, Hu K, Wang S, Wang R, Du J, He B, Ma J, Zhong X, Mu L, Cai S, Zhu X, Xing W, Yu J, Deng M, Gao Z. Etiologic diagnosis of lower respiratory tract bacterial infections using sputum samples and quantitative loop-mediated isothermal amplification. PLoS One. 2012;7(6):e38743. doi: 10.1371/journal.pone.0038743. Epub 2012 Jun 14.

Reference Type: DERIVED

PMID: 22719933 (View on PubMed)

Other Identifiers

2006AA02Z4A9

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2006AA02Z4A9

Identifier Type: -

Identifier Source: org_study_id