Clinical study
ACTIVE1
Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
| Status | Withdrawn |
|---|---|
| Type | Trial |
| Countries | Location not listed |
| Conditions studied | Prosthetic Joint Infection; Bacterial Infections |
| Study years | 2022 (estimated)–2024 (estimated) |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
Inclusion Criteria: * Males or females ≥18 years of age. * Stopped or not received SAT for 2 weeks * Female patients of childbearing potential who agree to use contraception. * First time chronic prosthetic joint infection * Confirmed phage match * No anticipated need for long-term antibiotics Exclusion Criteria: * Soft tissue defect requiring reconstruction. * Hardware misalignment * Additional orthopedic hardware in connection with the infected prosthesis. * Active infection * Unable to tolerate SAT * Septic shock or hemodynamic instability. * Chronic kidney disease * Liver disease * Decompensated heart failure. * Positive drug screen * Receiving chemotherapy * Immunocompromised * Antiviral treatment within 2 weeks prior to DAIR * Currently participating in another clinical trial * Known phage allergy * Pregnant/ breastfeeding * Lack of capacity to consent
Study description
This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis.
Study registrations
| ClinicalTrials.gov | NCT05269121 |
|---|
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct05269121 |
|---|