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Pathogen Identification of Bacterial Pneumonia Via DNA Detection
This study is ongoing, but not recruiting participants.
Study NCT00567827   Information provided by Peking University People's Hospital
First Received: December 4, 2007   Last Updated: September 17, 2009   History of Changes

December 4, 2007
September 17, 2009
December 2007
June 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00567827 on ClinicalTrials.gov Archive Site
 
 
 
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

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

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.

 
Observational
Cohort, Prospective
Pneumonia
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
2500
December 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00567827
Professor Zhancheng Gao,, Peking University People's Hospital
2006AA02Z4A9, 2006AA02Z4A9
Peking University People's Hospital
 
Principal Investigator: Zhancheng Gao, Professor Peking University People's Hospital
Peking University People's Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP