Clinical trials: PJI
Arthoplasty, Infected Hernioplasty Mesh
Assessment of Functional Outcomes of Custom-made Articulating Spacers in Two Stage Arthroplasty for Treatment of Infected Hip Joint
The goal of this prospective observational study is to evaluate whether the use of a Custom-Made Articulating Spacer (CUMARS) can achieve satisfactory functional outcomes and effective infection control in patients undergoing…
- Conditions
- Arthoplasty, Infected Hernioplasty Mesh, PJI
- Trial name
- NCT07453329
- Testing
- the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints.
- Where
- Egypt
- Volunteers
- 25 people
- Sponsor
- Ain Shams University
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.
Bone and Joint Infection, Antibiotic Reaction
Evaluation of the Tolerance of Ceftaroline and Ceftobiprole in the Management of BJI / PJI
Staphyloccous aureus and coagulase negative staphylocci are responsible of a large marjority of PJI. Regarding the high rate of methicillin resistance, current guidelines recommend the use of a glycopeptide, and most frequently…
- Trial name
- NCT04409769
- Testing
- Description of use of ceftaroline and ceftobiprole
- Where
- France
- Volunteers
- 22 people
- Sponsor
- Hospices Civils de Lyon
Periprosthetic Joint Infection (PJI)
Efficacy of Serum ESR, CRP, Synovial Leucocyte Esterase Dipstick Test in The Diagnosis of Chronic Infection in Total Joint Arthroplasty
aim of this study was to determine accuracy of using leucocyte esterase (LE),Erythroscyte sedimentation rates (ESR) and C- Reactive protein (CRP) for diagnosing periprosthetic joint infections (PJI)
- Trial name
- ESR/CRP/LE pji (NCT07718386)
- Testing
- CRP, ESR, Leukocyte esterase dipstick test
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Ain Shams University
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 Infection, Oral Antibiotics
Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI
Cutibacterium acnes (C. acnes) is an anaerobic aerotolerant bacteria commonly isolated during revision shoulder surgery. It is increasingly recognized as a pathogen, mainly in implant-related infections.
- Conditions
- Periprosthetic Infection, Oral Antibiotics, Revision Total Shoulder Arthroplasty
- Trial name
- NCT04636125
- Testing
- Doxycycline 100 MG Oral Tablet
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rothman Institute Orthopaedics
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
Bone and Join Infection (BJI), Periprosthetic Joint Infection (PJI)
Prospective Study of Patients Treated for Bone and Joint Infection (BJI) Due to Staphylococcus Aureus, Aiming at Identifying Biomarkers of Diagnosis Interest in Chronic BJI
There are more than one million (> 40,000 cases per year in France) of osteoarticular infections (OAI) yearly in the world. The number of these infections is constantly increasing due to an increase in life expectancy associated…
- Trial name
- ESPRI-IOAC (NCT04583241)
- Testing
- Constitution of serum bank at D0, Constitution of serum bank during follow-up, ELISA assays of serum markers of bone remodeling at D0
- Where
- France
- Volunteers
- 28 people
- Sponsor
- Hospices Civils de Lyon
Periprosthetic Joint Infection (PJI), Periprosthetic Knee Infection
Analysis of the Etiopathogenesis of Postoperative Complications in Orthopedic Patients Using Knee and Hip Arthroplasty as an Example
Relevance and Rationale Due to the widespread development of high-tech medical care in traumatology and orthopedics for patients with severe forms of hip and knee osteoarthritis and aseptic necrosis, and the increasing number of…
- Conditions
- Periprosthetic Joint Infection (PJI), Periprosthetic Knee Infection, Periprosthetic Hip Infection, Diagnostic
- Trial name
- NCT07813832
- Where
- Russia
- Volunteers
- 750 people
- Sponsor
- People's Friendship University of Russia
Periprosthetic Joint Infection (PJI)
Molecular Biology in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections
The goal of this observational study is to measure the diagnostic accuracy of the Multiplex PCR technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment…
- Trial name
- MOLPJI (NCT06804265)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Periprosthetic Joint Infection, PJI
Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID
The primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity.
- Trial name
- MID (NCT05320354)
- Testing
- Microbial ID test
- Where
- 6 sites in Germany, Netherlands and 4 more
- Volunteers
- 200 people
- Sponsor
- UMC Utrecht
Knee Osteoarthritis, PJI
Joint Microbiome Study for the Knee
Prosthetic joint infection (PJI) is a devastating complication following arthroplasty. An utmost effort has been done to clarify risk factors and microbiology of PJI.
- Trial name
- NCT05254145
- Testing
- Next Generation Sequencing
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rothman Institute Orthopaedics
PJI, Spondylodiscitis
Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections
Periprosthetic Joint infections (PJI) and spondylodiscitis are considered some of the most costly infectious diseases because require at least one surgery, prolonged hospitalisation, rehabilitation care, prolonged antibiotherapy…
- Trial name
- Ortho-PoC (NCT06666023)
- Testing
- Device
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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