Pathogen Identification of Bacterial Pneumonia Via DNA Detection

This study has been completed.
Sponsor:
Information provided by:
Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT00567827
First received: December 4, 2007
Last updated: June 23, 2010
Last verified: June 2010
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00567827

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

No publications provided by Peking University People's Hospital

Additional 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
Study First Received: December 4, 2007
Last Updated: June 23, 2010
Health Authority: China: Ethics Committee

Keywords provided by Peking University People's Hospital:
Pneumonia

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

ClinicalTrials.gov processed this record on October 29, 2014