Pathogen Identification of Bacterial Pneumonia Via DNA Detection
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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 |
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) |
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 |
Greater than 18 years of age. Cough present greater than one day and a history of fever and X-ray evidence of pneumonia.
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 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, Bacterial Pneumonia Bacterial Infections |
Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013