Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT04787250
Status:
WITHDRAWN
Last Update Posted:
2022-04-04
First Post:
2021-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacteriophage Therapy in Patients With Prosthetic Joint Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071059', 'term': 'Phage Therapy'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, open-label, parallel-group design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Changes to protocol design', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2021-02-18', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of phage therapy', 'timeFrame': 'Day 1 through Week 26', 'description': 'Incidence and type of adverse events and infusion reactions'}], 'secondaryOutcomes': [{'measure': 'Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.', 'timeFrame': '6 weeks after completion of phage therapy', 'description': 'Proportion of phage-treated patients with no need for surgery by no evidence of a prosthetic joint infection.'}, {'measure': 'Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).', 'timeFrame': 'Week 26', 'description': 'Time to reach minimum clinically important difference in hip dysfunction and osteoarthritis outcome score.'}, {'measure': 'Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).', 'timeFrame': 'Week 26', 'description': 'Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prosthetic', 'Joint', 'Knee', 'Hip', 'Phage', 'Bacteriophage', 'Prosthetic Joint'], 'conditions': ['Prosthetic Joint Infection']}, 'descriptionModule': {'briefSummary': 'This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.', 'detailedDescription': 'This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.\n\nThis study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'General Inclusion Criteria:\n\n* Males or females ≥18 years of age.\n* Female patients of childbearing potential who agree to use contraception.\n* Candidate for a two-stage exchange arthroplasty.\n* Chronic prosthetic joint infection\n\nGeneral Exclusion Criteria:\n\n* Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure\n* Soft tissue defect requiring reconstruction\n* Hardware misalignment or loosening\n* Active osteomyelitis\n* Septic shock or hemodynamic instability\n* Stage 4 or greater chronic kidney disease\n* Liver disease\n* Decompensated cirrhosis\n* Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis\n* Decompensated heart failure\n* Any other clinically significant disease, per judgement of the investigator\n* Neutropenia (neutrophil count \\< 1000 cells/cubic mm), thrombocytopenia (platelets \\< 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \\> 3 time the upper limit of normal\n* HIV, hepatitis C, hepatitis B infection\n* Positive drug screen\n* Receipt of chemotherapy, immunosuppressants or immune modulators\n* Anti-viral medication\n* Any known phage allergy\n* Breast feeding or pregnancy'}, 'identificationModule': {'nctId': 'NCT04787250', 'briefTitle': 'Bacteriophage Therapy in Patients With Prosthetic Joint Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adaptive Phage Therapeutics, Inc.'}, 'officialTitle': 'Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty', 'orgStudyIdInfo': {'id': 'APT.PJI.001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1, Phage Therapy with Antibiotic Treatment', 'description': 'Phage therapy will be administered in conjunction with antibiotic treatment.', 'interventionNames': ['Biological: Phage Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2, Standard of Care', 'description': 'Two-stage exchange arthroplasty entails resection arthroplasty and placement of an antibiotic-loaded spacer, antibiotic therapy, an antibiotic-free observation period, and re-implantation of a new prosthesis.', 'interventionNames': ['Procedure: Two-Stage Exchange Arthroplasty']}], 'interventions': [{'name': 'Phage Therapy', 'type': 'BIOLOGICAL', 'otherNames': ['Antibiotics'], 'description': "Phage will be administered based on patient's matching results.", 'armGroupLabels': ['Arm 1, Phage Therapy with Antibiotic Treatment']}, {'name': 'Two-Stage Exchange Arthroplasty', 'type': 'PROCEDURE', 'otherNames': ['Antibiotics'], 'description': "Performed per the study center's standard of care. No investigational products are used.", 'armGroupLabels': ['Arm 2, Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Robert J Hopkins, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adaptive Phage Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adaptive Phage Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}