Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 4:51 PM
Study NCT ID:
NCT06814756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071059', 'term': 'Phage Therapy'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single patient'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Clinical response to phage therapy as determined by participant's absence of physical symptoms", 'timeFrame': '1 year', 'description': 'Resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever. This will be determined by a questionnaire and monthly assessments by a Infectious Disease physician.'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events', 'timeFrame': '29 days', 'description': 'The safety outcome focuses on monitoring and documenting any adverse events (both serious and not) or reactions associated with bacteriophage therapy. Key safety measures include observing for immediate allergic reactions during the first dose, conducting regular clinical assessments, and performing routine bloodwork to detect any potential organ damage or unexpected side effects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bacteriophage', 'Periprosthetic joint infection', 'Phage therapy'], 'conditions': ['Prosthetic Joint Infections of Hip']}, 'descriptionModule': {'briefSummary': 'This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage drug product to treat and prevent the recurrence of a Morganella morganii prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to their quality of life. The treatment involves 2 intra-articular injections of bacteriophages into the joint and surrounding area and 14 days of intravenous phage therapy. The goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of active chronic prosthetic joint infection\n* Causative bacteria is susceptible to bacteriophage therapy in vitro\n* History of multiple failed antibiotic and surgical interventions\n\nExclusion Criteria:\n\n* Stage 5 chronic kidney disease\n* Cirrhosis\n* A known allergy to phage products\n* Fever\n* Involvement in another clinical trial\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06814756', 'acronym': 'PHAGE-MOM-001', 'briefTitle': 'Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection', 'orgStudyIdInfo': {'id': 'REB25-0157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label Arm', 'description': 'Bacteriophage drug product', 'interventionNames': ['Biological: phage therapy']}], 'interventions': [{'name': 'phage therapy', 'type': 'BIOLOGICAL', 'description': 'Single anti-Morganella morganii bacteriophage drug product', 'armGroupLabels': ['Open Label Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'country': 'Canada', 'facility': 'Foothills Medical Centre, University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qeen Biotechnologies', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}