Clinical trials: Prosthetic Joint Infection (PJI)
Prosthetic Joint Infection (PJI)
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
This is a Phase 2b, randomized, controlled, open-label clinical study evaluating the efficacy, safety, and local PK profiles of TNP-2092 administered via IA injection on a background of antibiotic treatment in participants with…
- Trial name
- NCT07858916
- Testing
- TNP-2092 for injection, Vancomycin Hydrochloride for Injection, Oral antibiotics
- Where
- China
- Volunteers
- 40 people
- Sponsor
- TenNor Therapeutics (Zhongshan) Limited
Joint Infection
Can Intraosseous Antibiotics Improve the Results of Irrigation & Debridement and Prosthetic Retention for PJI?
Purpose of Study: In order to improve upon the variable results seen in irrigation and debridement for periprosthetic infection, we ask if the use of intraosseous regional administration of antibiotics at the time of irrigation…
- Trial name
- NCT03713528
- Testing
- Intraoperative Intraosseous Vancomycin
- Where
- 10 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- OrthoCarolina Research Institute, Inc.
Bone and Joint Infection, Antibiotic Resistant Staphylococcus Aureus Infection
Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin
S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.
- Trial name
- IPASTAPH (NCT03750721)
- Testing
- Role of rifampin in staphylococcal PJI
- Where
- France
- Volunteers
- 79 people
- Sponsor
- Hospices Civils de Lyon
Hip Prosthesis Infection, Knee Prosthesis Infection
Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic Joint Infections Due to Staphylococcus Aureus Treated by DAIR.
Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics.
- Trial name
- GLORIA (NCT06605651)
- Testing
- Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution, 0.9% NaCl solution
- Volunteers
- 100 people
- Sponsor
- Phagenix
Osteoarthritis, Hip, Total Hip Arthroplasty
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
Aim: To compare the effect of one single dose versus multiple doses of prophylactic antibiotics administered within 24 hours, on the development of PJI in patients with osteoarthritis undergoing primary THA.
- Conditions
- Osteoarthritis, Hip, Total Hip Arthroplasty, Prosthetic-joint Infection
- Trial name
- ProHipQ-OA (NCT05530551)
- Testing
- Antibiotic dosage practice
- Where
- 36 sites in Denmark
- Volunteers
- 20,000 people
- Sponsor
- Soren Overgaard
Prosthetic Joint Infection
Abbreviated Protocol for Two-Stage Exchange
Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days).
- Trial name
- APEX (NCT04662632)
- Testing
- VT-X7 Treatment System with Tobramycin Sulfate, Standard of Care, Two-stage exchange arthroplasty
- Where
- 17 sites in United States
- Volunteers
- 76 people
- Sponsor
- Osteal Therapeutics, Inc.
Prosthetic-joint Infection
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement…
- Trial name
- RETAIN (NCT07214311)
- Testing
- PLG0206
- Where
- 21 sites in United States, United Kingdom
- Volunteers
- 240 people
- Sponsor
- Peptilogics
Periprosthetic Joint Infection (PJI)
Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice?
This retrospective multi-center, multi-national cohort study is to validate the European Bone and Joint Infection Society (EBJIS) Definition of Prosthetic Joint Infection.
- Trial name
- NCT05117671
- Testing
- data collection to classify infection status
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 1,554 people
- Sponsor
- University Hospital, Basel, Switzerland
Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Prosthetic Joints Infection (PJI)
Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants
This is a phase 1, single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial of single and multiple intravenous doses of TNP-2092 for injection in healthy Chinese participants.
- Trial name
- NCT06394518
- Testing
- TNP-2092 for injection
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics Inc.
Lower Limb Megaprosthetis Infection
Epidemiology, Risk Factors, and Outcomes of Infections of Lower Limb MEGAprostheses
Retrospective, multicenter, non-profit observational study. The study will include consecutive patients who underwent lower-limb megaprosthesis implantation at the participating Centers between January 1, 2020, and June 30, 2023.
- Trial name
- EROMEGA (NCT07544212)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Prosthetic Joint Infection
PCA Administration in Prosthetic Joint Infection
Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection
- Trial name
- NCT06591741
- Testing
- Oral PCA
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Dr. Dean Reeves Clinic
Prosthetic Infection
Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR
Rifampicin, is key in the treatment of staphylococcal PJIs. Rifabutin has a better profile of tolerance than rifampicin regarding the risk of interaction with concomitant medications and liver disorders.
- Trial name
- RIFAMAB (NCT04672525)
- Testing
- Rifabutin, Rifampicin
- Where
- 30 sites in France
- Volunteers
- 436 people
- Sponsor
- Tourcoing Hospital
Prosthetic-joint Infection
Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis (Sonic)
This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in…
- Trial name
- Sonic (NCT05265598)
- Where
- Switzerland
- Volunteers
- 176 people
- Sponsor
- University Hospital, Basel, Switzerland
Prosthesis-Related Infections
PCA Loading Time Before Knee Prosthetic Joint Infection Revision
Proof of principle pilot study of the effect of dietary nutritional loading of protocatechunic acid (PCA) on the health and welfare of individuals with prosthetic joint infection (PJI), as measured by standard biomarkers
- Trial name
- NCT06591728
- Testing
- Oral PCA
- Volunteers
- 10 people
- Sponsor
- Dr. Dean Reeves Clinic
Prosthetic Joint Infection
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
- Trial name
- ACTIVE2 (NCT05269134)
- Testing
- Bacteriophage
- Where
- 10 sites in United States
- Sponsor
- Adaptive Phage Therapeutics, Inc.
Prosthetic Joint Infection
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the…
- Trial name
- NCT03721328
- Testing
- vancomycin hydrochloride and tobramycin sulfate
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Osteal Therapeutics, Inc.
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
The goal of this clinical trial is to compare two types of skin preparation solutions (chlorhexidine gluconate-alcohol solution and povidone-iodine solution) that help eliminate harmful bacteria on the skin at the time of surgery…
- Trial name
- CLEANJoint (NCT05828810)
- Testing
- Chlorhexidne Gluconate-Alcohol Skin Preparation, Poviodine-iodine Skin Preparation
- Where
- 3 sites in Canada
- Volunteers
- 400 people
- Sponsor
- Sunnybrook Health Sciences Centre
Periprosthetic Joint Infection (PJI)
Preop Biomarkers as Outcome Predictors in 2 Stage Revision Surgery for PJI
With the progressive ageing of the population, a significant increase in the incidence of skeletal fractures-particularly of the proximal femur-as well as degenerative conditions such as osteoarthritis has been observed, for…
- Trial name
- ARKO-PJI (NCT07358455)
- Volunteers
- 200 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hip Prosthetic Joint Infection, Knee Prosthetic Joint Infection
Short Interval in Treatment of PJI
Patients with hip, knee and shoulder PJI, will be treated with a two-stage exchange Revision. Patients will be randomized into 2 groups: the experimental Group will get a reimplantation after a short interval (2-3 weeks) while…
- Conditions
- Hip Prosthetic Joint Infection, Knee Prosthetic Joint Infection, Shoulder Prosthetic Joint Infection
- Trial name
- Fast-track (NCT02372435)
- Testing
- Shortening of the interval of two-stage prosthesis exchange
- Volunteers
- 418 people
- Sponsor
- Charite University, Berlin, Germany
Prosthetic Joint Infection
Alpha Defensin and 16S rRNA Gene in Diagnosis of PJI
Total joint replacement is considered one of the most successful surgical procedures in the field of orthopedics. Despite this achievement, prosthetic joint infections is still considered a severe complication often leading to…
- Trial name
- NCT03714165
- Testing
- Alpha defensin and 16SrRNA gene
- Where
- Egypt
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Assiut University