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Pathogen Identification of Bacterial Pneumonia Via DNA Detection

Identification of Bacterial Species and Their Antibiotic-Resistant Spectrum in Sputum Specimen From the Patients With Pneumonia Via Nuclear Acid Detection Assay

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00567827
Enrollment
2896
Registered
2007-12-05
Start date
2007-12-31
Completion date
2009-12-31
Last updated
2010-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

Pneumonia

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.

Interventions

None listed

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026