Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 12:55 AM
Study NCT ID:
NCT07202234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-25', 'size': 142982, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-26T02:48', 'hasProtocol': True}, {'date': '2025-05-25', 'size': 152055, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-26T02:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response rate', 'timeFrame': 'From enrollment to the end of treatment (within 10 days of enrollment)'}], 'secondaryOutcomes': [{'measure': 'Bacterial clearance rate', 'timeFrame': '10 days after enrollment'}, {'measure': '28-day mortality', 'timeFrame': '28 days after enrollment'}, {'measure': 'Length of hospital stay', 'timeFrame': '28 days after enrollment'}, {'measure': 'Length of invasive mechanical ventilation', 'timeFrame': '28 days after enrollment'}, {'measure': 'CPIS score', 'timeFrame': '1，5，10 days after enrollment', 'description': 'Full Title: Clinical Pulmonary Infection Score (CPIS);Range: Minimum: 0, Maximum: 12\n\n;Interpretation: Higher score indicates more severe infection.'}, {'measure': 'SOFA score', 'timeFrame': '1，5，10 days after enrollment', 'description': 'Full Title: Sequential Organ Failure Assessment (SOFA) Score;Range: Minimum: 0, Maximum: 24\n\n;Interpretation: Higher score indicates greater organ dysfunction.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['phage therapy', 'ventilator-associated pneumonia', 'phage cocktail'], 'conditions': ['VAP - Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to systematically evaluate the efficacy and safety of bacteriophage cocktail therapy in patients with ventilator-associated pneumonia caused by Gram-negative bacterial infections.', 'detailedDescription': 'This study investigates the clinical application of bacteriophage therapy in severe infections through a prospective, randomized, multi-center trial targeting ventilator-associated pneumonia (VAP) caused by multidrug-resistant Gram-negative bacteria. The trial will comprehensively assess the efficacy, safety, and applicability of inhaled bacteriophage cocktail therapy, providing high-quality clinical evidence to support the establishment of an evidence-based framework for phage therapy. The primary endpoint is clinical response rate, with secondary endpoints including bacterial clearance and 28-day mortality, aiming to determine the therapeutic potential and clinical value of phage cocktails in VAP treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with ventilator-associated pneumonia (VAP);\n2. Identified infection with MDR Klebsiella pneumoniae, Acinetobacter baumannii, or Pseudomonas aeruginosa via MROSE evaluation and antimicrobial susceptibility testing (AST) from this or other tertiary hospitals;\n3. Aged 18 to 85 years;\n4. Written informed consent obtained from the patient or legal guardian.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women;\n2. FiO₂ ≥ 70% or PEEP ≥ 15 cmH₂O;\n3. Hemodynamic instability (vasopressor dose increased by ≥30% in the last 6 hours or norepinephrine \\> 0.5 μg/kg/min);\n4. Known allergy to phage components.'}, 'identificationModule': {'nctId': 'NCT07202234', 'briefTitle': 'Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia', 'orgStudyIdInfo': {'id': 'Phage-2025YFC3408504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Nebulized normal saline inhalation therapy', 'interventionNames': ['Drug: Nebulized normal saline inhalation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'phage therapy group', 'description': 'Phage cocktail administered via nebulization', 'interventionNames': ['Drug: Phage cocktail administered via nebulization']}], 'interventions': [{'name': 'Phage cocktail administered via nebulization', 'type': 'DRUG', 'description': 'Phage cocktail administered via nebulization，BID', 'armGroupLabels': ['phage therapy group']}, {'name': 'Nebulized normal saline inhalation therapy', 'type': 'DRUG', 'description': 'Nebulized normal saline inhalation therapy, BID', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiuli Wang', 'role': 'CONTACT', 'email': 'wxl981003@163.com', 'phone': '+86 18686045253'}, {'name': 'Weihua Zhang', 'role': 'CONTACT', 'email': 'whuazhang@126.com', 'phone': '+86 18610607819'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': 'Zhengzhou Central Hospital', 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'The 8th medical center of chinese PLA general hospital', 'class': 'UNKNOWN'}, {'name': 'The First Medical Center of Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'wang kaifei', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}