WithdrawnPhase 1/2

Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections

Stopped: Sponsor Decision

0Started 2022-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection

Timeframe: Day 1 through Week 24

Treatment success

Timeframe: 13 months after DAIR

Trial details

NCT IDNCT05269121

SponsorAdaptive Phage Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11

View on ClinicalTrials.gov More Prosthetic Joint Infection trials