Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06986512
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rapid Detection of Pseudomonas Aeruginosa in Bronchoalveolar Lavage Fluid Using Label-free Single-particle Imaging Technology and Assessment of Post-treatment Efficacy in Patients With Pseudomonas Aeruginosa Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011552', 'term': 'Pseudomonas Infections'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001999', 'term': 'Bronchoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The investigators will dynamically and continuously collect bronchoalveolar lavage fluid samples from participants and diagnosed with Pseudomonas aeruginosa infection.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The size of pathogens', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': 'Measure the size of pathogens'}, {'measure': 'scattering intensity of pathogen', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': 'Determine the shape of pathogens through scattering intensity'}, {'measure': 'movement speed of pathogens', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': 'Measure the movement speed of pathogens, such as flagellates like Pseudomonas aeruginosa, which have a fast movement speed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rapid Detection', 'Pseudomonas Aeruginosa Infection']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to observe specimens of bronchoalveolar lavage fluid from patients using a reflection enhanced dark-field scattering microscopy. By observing parameters such as the size, morphology, scattering intensity, and movement speed of pathogens, combined with the clinical characteristics of patients, a rapid diagnosis of Pseudomonas aeruginosa infection can be made. At the same time, the bronchoalveolar lavage fluid samples of patients infected with Pseudomonas aeruginosa before and after treatment were compared, and the quantity and vitality of Pseudomonas aeruginosa were observed to judge the efficacy of antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Suspected or diagnosed patients with pulmonary infection caused by Pseudomonas aeruginosa', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years and above\n* After admission, Pseudomonas aeruginosa was cultured in bronchoalveolar lavage fluid or lower respiratory tract aspirates\n\nExclusion Criteria:\n\n* Age under 18 years old or over 90 years old\n* Pregnancy, lactation period -'}, 'identificationModule': {'nctId': 'NCT06986512', 'briefTitle': 'Rapid Detection of Pseudomonas Aeruginosa in Bronchoalveolar Lavage Fluid Using Label-free Single-particle Imaging Technology and Assessment of Post-treatment Efficacy in Patients With Pseudomonas Aeruginosa Infection', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Rapid Detection of Pseudomonas Aeruginosa in Bronchoalveolar Lavage Fluid Using Label-free Single-particle Imaging Technology and Assessment of Post-treatment Efficacy in Patients With Pseudomonas Aeruginosa Infection', 'orgStudyIdInfo': {'id': '2024-SR-806'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bronchoscopy', 'type': 'PROCEDURE', 'description': 'We will perform bronchoscopy and collect bronchoalveolar lavage fluid (BALF)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Wenkui Sun', 'role': 'CONTACT', 'email': 'sunwenkui@njmu.edu.cn', 'phone': '+86 13914742215'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Wenkui Sun, Dr', 'role': 'CONTACT', 'email': 'sunwenkui@njmu.edu.cn', 'phone': '+86 13914742215'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}