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:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04787250
Eligibility Criteria:
General Inclusion Criteria:
* Males or females ≥18 years of age.
* Female patients of childbearing potential who agree to use contraception.
* Candidate for a two-stage exchange arthroplasty.
* Chronic prosthetic joint infection
General Exclusion Criteria:
* Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure
* Soft tissue defect requiring reconstruction
* Hardware misalignment or loosening
* Active osteomyelitis
* Septic shock or hemodynamic instability
* Stage 4 or greater chronic kidney disease
* Liver disease
* Decompensated cirrhosis
* Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis
* Decompensated heart failure
* Any other clinically significant disease, per judgement of the investigator
* Neutropenia (neutrophil count \< 1000 cells/cubic mm), thrombocytopenia (platelets \< 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \> 3 time the upper limit of normal
* HIV, hepatitis C, hepatitis B infection
* Positive drug screen
* Receipt of chemotherapy, immunosuppressants or immune modulators
* Anti-viral medication
* Any known phage allergy
* Breast feeding or pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04787250
Study Brief:
Protocol Section:
NCT04787250