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Pathogen Identification of Bacterial Pneumonia Via DNA Detection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567827
First Posted: December 5, 2007
Last Update Posted: June 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Peking University People's Hospital
  Purpose
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

Condition
Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Bacterial Species and Their Antibiotic-Resistant Spectrum in Sputum Specimen From the Patients With Pneumonia Via Nuclear Acid Detection Assay

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Biospecimen Retention:   Samples With DNA
DNA extracted from sputum specimen

Enrollment: 2896
Study Start Date: December 2007
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Greater than 18 years of age. Cough present greater than one day and a history of fever and X-ray evidence of pneumonia.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567827


Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Zhancheng Gao, Professor Peking University People's Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Zhancheng Gao,, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT00567827     History of Changes
Other Study ID Numbers: 2006AA02Z4A9
2006AA02Z4A9 ( Other Grant/Funding Number: the National Hi-Tech Project of P.R. China )
First Submitted: December 4, 2007
First Posted: December 5, 2007
Last Update Posted: June 24, 2010
Last Verified: June 2010

Keywords provided by Peking University People's Hospital:
Pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections