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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04763759
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of PJI of the knee or hip
* Identified pathogen(s) must be susceptible to antibiotic regimen
* Planned/scheduled for primary two-stage exchange arthroplasty
* BMI \< 40 kg/m²
* Willing and able to provide written informed consent
* Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
* Men and women of child bearing potential (WOCBP) must be willing to practice a highly effective method of contraception
Exclusion Criteria:
* Evidence of active infection other than bacterial PJI of the knee or hip
* Inability to receive or intolerant to pathogen-appropriate systemic or oral antibiotic therapy
* Chronic obstructive pulmonary disease (COPD)
* Child-Pugh score \> 6
* Congestive heart failure
* Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids
* Active malignancy, or history of malignancy or chemotherapy within the past 2 years
* Active or history of autoimmune disease
* Uncontrolled diabetes, defined as hemoglobin A1c \> 7.4%
* Clinically significant abnormality on electrocardiogram (ECG) that would preclude subject from undergoing two-stage exchange arthroplasty
* Clinically significant serum chemistry or hematology abnormalities
* Any acute illness within 14 days of Day 1 that could confound the evaluation of safety evaluation
* Known or suspected intolerance or hypersensitivity to any biologic medication
* Received a therapeutic antibody or biologic within the 6 months prior to Screening
* Positive serum test for pregnancy, pregnant, or nursing women
* Positive reverse transcription polymerase chain reaction (RT -PCR) or alternative (antigen) test for acute respiratory syndrome coronavirus 2
* History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the subject's ability to comply with the study requirements
* Any other comorbidity or condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04763759
Study Brief:
Protocol Section:
NCT04763759