Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT05269134
Eligibility Criteria:
Inclusion Criteria:
* Males or females ≥18 years of age
* Recurrent PJI of the knee or hip
* Female patients of childbearing potential who agree to use contraception.
* 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 (other than PJI) requiring long term IV antibiotics
* Unable to tolerate SAT
* Septic shock or hemodynamic instability
* Stage 4 or greater chronic kidney disease
* Liver disease
* Decompensated heart failure
* Positive drug screen
* Receiving chemotherapy
* Immunocompromised
* Treatment with antiviral medication within 2 weeks prior to randomization
* Currently participating in another clinical trial
* Known phage allergy
* Pregnant/ breast feeding
* Lack of capacity to consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05269134
Study Brief:
Protocol Section:
NCT05269134