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OpenTrials
Completed

NCT Number: NCT00567827

Pathogen Identification of Bacterial Pneumonia Via DNA Detection

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2007
Registry last updated
Jun 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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