Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT05269134
Status:
WITHDRAWN
Last Update Posted:
2023-11-30
First Post:
2022-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2022-02-25', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI', 'timeFrame': 'Day 1 through Week 24', 'description': 'Incidence of reactions to study treatment and discontinuation due to adverse events'}, {'measure': 'To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI', 'timeFrame': 'Day 1 through 24 months', 'description': 'Time to recurrence or evidence of infection with the original pathogen at the same joint'}], 'secondaryOutcomes': [{'measure': 'Treatment success', 'timeFrame': 'Day 1 through 12 months', 'description': 'No recurrence or evidence of infection with the original pathogen at the same joint'}, {'measure': 'No recurrence or evidence of infection for any reason', 'timeFrame': '12 months after DAIR', 'description': 'Infection due to the original pathogen or a different pathogen'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prosthetic', 'Joint', 'Knee', 'Hip', 'Phage', 'Bacteriophage', 'Prosthetic Joint', 'DAIR'], '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 at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae.\n\nThis study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females ≥18 years of age\n* Recurrent PJI of the knee or hip\n* Female patients of childbearing potential who agree to use contraception.\n* Confirmed phage match\n* No anticipated need for long-term antibiotics\n\nExclusion Criteria:\n\n* Soft tissue defect requiring reconstruction\n* Hardware misalignment\n* Additional orthopedic hardware in connection with the infected prosthesis\n* Active infection (other than PJI) requiring long term IV antibiotics\n* Unable to tolerate SAT\n* Septic shock or hemodynamic instability\n* Stage 4 or greater chronic kidney disease\n* Liver disease\n* Decompensated heart failure\n* Positive drug screen\n* Receiving chemotherapy\n* Immunocompromised\n* Treatment with antiviral medication within 2 weeks prior to randomization\n* Currently participating in another clinical trial\n* Known phage allergy\n* Pregnant/ breast feeding\n* Lack of capacity to consent'}, 'identificationModule': {'nctId': 'NCT05269134', 'acronym': 'ACTIVE2', 'briefTitle': 'Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adaptive Phage Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)', 'orgStudyIdInfo': {'id': 'APT.PJI.006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAIR + Phage Treatment + Antibiotics', 'description': 'Phage therapy will be administered in conjunction with antibiotic treatment.', 'interventionNames': ['Drug: Bacteriophage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DAIR + Placebo + Antibiotics', 'description': 'Placebo will be administered in conjunction with antibiotic treatment.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bacteriophage', 'type': 'DRUG', 'description': 'Phage Therapy', 'armGroupLabels': ['DAIR + Phage Treatment + Antibiotics']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['DAIR + Placebo + Antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Health Care Bone & Joint Insitute', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Snake River Research', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Baptist Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'WVU Medicine JW Ruby Memorial Hospital', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Edward Fang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Adaptive Phage Therapeutics, Chief Medical Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adaptive Phage Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}