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| Sponsor: | Peking University People's Hospital |
|---|---|
| Information provided by: | Peking University People's Hospital |
| ClinicalTrials.gov Identifier: | NCT00567827 |
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: | Cohort, 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
| Estimated Enrollment: | 2500 |
| Study Start Date: | December 2007 |
| Estimated 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:
Exclusion Criteria:
Contacts and Locations| China | |
| Departments of Respiratory and Critical Care Medicine | |
| Beijing, China, 100044 | |
| Principal Investigator: | Zhancheng Gao, Professor | Peking University People's Hospital |
More Information
| Responsible Party: | Peking University People's Hospital ( Professor Zhancheng Gao, ) |
| Study ID Numbers: | 2006AA02Z4A9, 2006AA02Z4A9 |
| Study First Received: | December 4, 2007 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00567827 History of Changes |
| Health Authority: | China: Ethics Committee |
|
Pneumonia |
|
Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Pneumonia, Bacterial Pneumonia |
