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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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