Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT07035535
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-28
First Post:
2025-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Predictive Value of Molecular Diagnostic Techniques in the Antimicrobial- Resistance Phenotypes of Pathogens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-06-15', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The outcome of the antimicrobial-resistance genes by tNGS', 'timeFrame': 'Up to 2 weeks after enrollment', 'description': 'The investigators use the targeted next-generation sequencing(tNGS) to detect the antimicrobial-resistance genes produced by klebsiella pneumoniae，acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus in patients with lower respiratory tract infections'}, {'measure': 'The outcome of bacteria antimicrobial susceptibility test', 'timeFrame': 'Up to 2 weeks after enrollment', 'description': 'The antimicrobial susceptibility test(AST) results of the klebsiella pneumoniae，acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antimicrobial Drug Resistance', 'High-Throughput Nucleotide Sequencing']}, 'descriptionModule': {'briefSummary': 'This observational study is to learn about the predictive value of targeted next-generation sequencing(tNGS) in pathogen resistance phenotype of patients with lower respiratory tract infection ,by detecting antimicrobial-resistant genes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population description specifies individuals diagnosed with LRTI (Lower Respiratory Tract Infection) who were enrolled based on culture-confirmed klebsiella pneumoniae，acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years and above\n* Lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°C or less than 36.5°C), leucocyte count abnormality (leucocyte count greater than 10\\*10\\^9/L or less than 4\\*10\\^9/L), and the presence of purulent tracheal secretions.\n* Patients have been performed tNGS test in-hospital, with the criterion that the reads per kilobase per million mapped reads(RPKM) for staphylococcus aureus exceeds 200, acinetobacter baumannii exceeds 300, klebsiella pneumoniae exceeds 20, or pseudomonas aeruginosa exceeds 100.\n\nExclusion Criteria:\n\n* Klebsiella pneumoniae，acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus were not cultured in BALF.'}, 'identificationModule': {'nctId': 'NCT07035535', 'briefTitle': 'The Predictive Value of Molecular Diagnostic Techniques in the Antimicrobial- Resistance Phenotypes of Pathogens', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'The Predictive Value of Targeted Next-generation Sequencing(tNGS) in the Antimicrobial- Resistance Phenotypes of Pathogens', 'orgStudyIdInfo': {'id': '2024-SR-1175'}}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Wenkui Sun', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Nanjing Medical University Nanjing, Jiangsu, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}