Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05270018
Status:
UNKNOWN
Last Update Posted:
2022-03-08
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095983', 'term': 'Bacterial Lysates'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAP incidence', 'timeFrame': '2 weeks', 'description': 'The incidence rate of ventilator associated pneumonia'}], 'secondaryOutcomes': [{'measure': 'Assessment of human immune status', 'timeFrame': 'one week', 'description': 'Immune status Assessment of IgG, IgA, and IgM levels Quantifications of IgG, IgA, and IgM levels were determined by Immunological Turbidity Kits'}, {'measure': 'drug resistant bacteria Incidence', 'timeFrame': 'one week', 'description': 'The incidence rate of drug resistant bacteria'}, {'measure': 'Composition of respiratory bacteria', 'timeFrame': 'one week', 'description': 'probiotics and pathogens via NGS analysis'}, {'measure': 'survival rate', 'timeFrame': '28 days', 'description': 'ICU in-hospital mortality and 28 day mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ventilators; Bacterial Lysates; Microecology; pneumonia'], 'conditions': ['Ventilators, Mechanical']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of bacterial lysates on respiratory tract microecology in patients with mechanical ventilation and the efficacy of prevention and treatment of ventilator associated pneumonia.', 'detailedDescription': 'After being informed about the study and potential risks, all patients giving written informed consent will undergo a one-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to Bacterial Lysates( 14mg, once a day) or placebo(once a day).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to ICU for mechanical ventilation\n* The expected mechanical ventilation time is more than 72h\n* Sign the informed consent form when conscious and voluntary, and complete the questionnaire survey and follow-up as required; If it is unable to sign the informed consent form and complete the questionnaire survey and follow-up, the legal representative or guardian can act on behalf of it.\n\nExclusion Criteria:\n\n* Ventilator associated pneumonia is known and confirmed\n* Pregnant or lactating female\n* Allergic to the active ingredients of bacterial lysates or any excipients listed in the ingredients\n* Patients with autoimmune diseases\n* Patients with acute intestinal infection\n* Patients participating in other clinical studies at the same time\n* Patients considered unsuitable by other researchers to participate in this study'}, 'identificationModule': {'nctId': 'NCT05270018', 'briefTitle': 'Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Effect of Bacterial Lysates on Respiratory Tract Microecology in Patients With Mechanical Ventilation and Evaluation of the Efficacy of Prevention and Treatment of Ventilator-associated Pneumonia', 'orgStudyIdInfo': {'id': 'STPH-ICU-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bacterial Lysate group', 'description': 'Oral / gastric administration of bacterial lysate once a day on an empty stomach, 14.0mg each time for at least 5 days', 'interventionNames': ['Drug: Bacterial Lysates']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Oral / gastric administration of normal saline once a day, 14.0ml each time', 'interventionNames': ['Other: normal saline']}], 'interventions': [{'name': 'Bacterial Lysates', 'type': 'DRUG', 'otherNames': ['Fan fusu'], 'description': '14mg once a day', 'armGroupLabels': ['Bacterial Lysate group']}, {'name': 'normal saline', 'type': 'OTHER', 'description': '14.0ml once a day', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qixing Wang, MSc', 'role': 'CONTACT', 'email': 'wangqixing1221@163.com', 'phone': '86-21-66307153'}, {'name': 'Sheng Wang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Sheng Wang, MD, PhD', 'role': 'CONTACT', 'email': 'wangsheng@tongji.edu.cn', 'phone': '862166307174'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheng Wang MD PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Sheng Wang MD PhD', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}