None listed
Conditions
Brief summary
evaluating the safety, tolerability, and proof-of-concept efficacy of the investigational production BromAc® administered intra-articular in addition to standard-of-care suppressive antibiotic therapy. Participants will be followed for 90 days with clinical, laboratory, and patient-reported outcome assessments. It is hypothesized that BromAc will be safe and tolerable, with potential improvement in symptoms
Interventions
a single intra-articular injection of 10ml BromAc® (500microq bromelain + 10mg/ml N-acetylcystein) administered by an experienced trained clinician member of the research team using aseptic technique. This will be given without interruption or modification of the patient's standard suppressive antibiotic therapy (continuation of the same dose and antibiotic choice as prescribed by their regular treating Infectious disease physician prior to enrollment).
Sponsors
ACT Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged over 18 years, inclusive, at time of screening 2. Patients who are able to provide informed consent, geographically stable and able to comply with the required follow up visits, testing schedule and medical regimen 3. Patients with a confirmed diagnosis of a Prosthetic Joint Infection of the knee (as defined by European Bone & Joint Infection Society - EBJIS - criteria); who are on lifelong suppressive antibiotic therapy. 4. Patients with a life expectancy of at least 1 year
Exclusion criteria
1. Patients who are currently planned for further revision surgery of the affected knee prosthesis or ongoing active changes to standard of care treatment regardless of cause 2. Patients with mycobacterium or fungal etiology of Prosthetic Joint Infection (PJI) at time of screening 3. Patients who have active substance dependence or abuse that, in the investigator’s opinion, might interfere with patient safety and/or compliance with the protocol 4. Patients with malignant disease who have received immunosuppressive therapy, radiation therapy or chemotherapy within the last 3 months 5. Patients with known immunodeficiency (eg. Splenectomy, sickle cell anaemia, human immunodeficiency virus, recent bone marrow or other transplant 6. Female patients who are pregnant or lactating 7. Patients with allergy to the study drug or any excipients or components of the study drug 8. Patients who participated in any clinical trial of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, prior to study drug administration
Outcome results
None listed