Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-03-02 @ 8:40 PM
Study NCT ID:
NCT00567827
Status:
COMPLETED
Last Update Posted:
2010-06-24
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathogen Identification of Bacterial Pneumonia Via DNA Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA extracted from sputum specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2896}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-23', 'studyFirstSubmitDate': '2007-12-04', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2010-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pneumonia'], 'conditions': ['Pneumonia']}, 'referencesModule': {'references': [{'pmid': '22719933', 'type': 'DERIVED', 'citation': 'Kang Y, Deng R, Wang C, Deng T, Peng P, Cheng X, Wang G, Qian M, Gao H, Han B, Chen Y, Hu Y, Geng R, Hu C, Zhang W, Yang J, Wan H, Yu Q, Wei L, Li J, Tian G, Wang Q, Hu K, Wang S, Wang R, Du J, He B, Ma J, Zhong X, Mu L, Cai S, Zhu X, Xing W, Yu J, Deng M, Gao Z. Etiologic diagnosis of lower respiratory tract bacterial infections using sputum samples and quantitative loop-mediated isothermal amplification. PLoS One. 2012;7(6):e38743. doi: 10.1371/journal.pone.0038743. Epub 2012 Jun 14.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Greater than 18 years of age. Cough present greater than one day and a history of fever and X-ray evidence of pneumonia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater than 18 years of age.\n* Cough present greater than one day\n* History of fever\n* X-ray evidence of pneumonia.\n\nExclusion Criteria:\n\n* Pneumonia caused by TB, fungi and virus'}, 'identificationModule': {'nctId': 'NCT00567827', 'briefTitle': 'Pathogen Identification of Bacterial Pneumonia Via DNA Detection', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Identification of Bacterial Species and Their Antibiotic-Resistant Spectrum in Sputum Specimen From the Patients With Pneumonia Via Nuclear Acid Detection Assay', 'orgStudyIdInfo': {'id': '2006AA02Z4A9'}, 'secondaryIdInfos': [{'id': '2006AA02Z4A9', 'type': 'OTHER_GRANT', 'domain': 'the National Hi-Tech Project of P.R. China'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zhancheng Gao, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Zhancheng Gao,', 'oldOrganization': "Peking University People's Hospital"}}}}