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NCT00567827 Clinical Trial

Pathogen Identification of Bacterial Pneumonia Via DNA Detection

Pneumonia Clinical Trial

Official title:
Identification of Bacterial Species and Their Antibiotic-Resistant Spectrum in Sputum Specimen From the Patients With Pneumonia Via Nuclear Acid Detection Assay

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00567827
Other study ID # 2006AA02Z4A9
Secondary ID 2006AA02Z4A9
Status Completed
Phase N/A
First received December 4, 2007
Last updated June 23, 2010
Start date December 2007
Est. completion date December 2009

Study information
Verified date June 2010
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 2896
Est. completion date December 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital
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