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Prosthetic Joint Infection clinical trials

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NCT ID: NCT04763759 Completed - Clinical trials for Prosthetic Joint Infection

Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections

Start date: February 8, 2021
Phase: Phase 1
Study type: Interventional

TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.

NCT ID: NCT04662632 Completed - Clinical trials for Prosthetic Joint Infection

Abbreviated Protocol for Two-Stage Exchange

APEX
Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

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). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of periprosthetic joint infection (PJI). Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.

NCT ID: NCT04618276 Completed - Clinical trials for Surgical Site Infection

Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if PDT has an effect on bacterial skin colonization in order to improve skin antisepsis strategies for the prevention of surgical site infections.

NCT ID: NCT04409392 Completed - Clinical trials for Prosthetic Joint Infection

Staphylococcus Lugdunensis Prosthetic Joint Infection

Start date: February 1, 2021
Phase:
Study type: Observational

Staphylococcus lugdunensis is a coagulase-negative staphylococcus belonging to the human commensal cutaneous flora, and has been little studied in the field of prosthetic joint infections. However, it shares many virulence traits with Staphylococcus aureus, including many adhesins and its ability to form biofilm, and the few series of cases reports a significant failure rate.

NCT ID: NCT04294862 Completed - Clinical trials for Prosthetic Joint Infection

Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty

Start date: March 1, 2021
Phase: Phase 1
Study type: Interventional

This study will investigate TNP-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (THA) or a total knee arthroplasty (TKA). Tissue distribution is the primary objective, and plasma pharmacokinetics (PK), safety, and tolerability are secondary objectives.

NCT ID: NCT04067843 Completed - Clinical trials for Surgical Site Infection

Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study

PHOMIC
Start date: September 26, 2019
Phase: N/A
Study type: Interventional

The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if photodynamic therapy has an effect on bacterial skin colonization and decrease number of colonizing bacteria associated with sebaceous and sweat glands in order to improve skin antisepsis strategies for the prevention of surgical site infections.

NCT ID: NCT04042233 Completed - Joint Diseases Clinical Trials

Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

Start date: December 31, 2019
Phase: Phase 4
Study type: Interventional

The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.

NCT ID: NCT03848091 Completed - Clinical trials for Antibiotic Resistant Infection

Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in At-risk Patients

Start date: April 1, 2016
Phase:
Study type: Observational

One-step exchange arthroplasty is more and more used in the treatment of chronic infections, especially in patients at risk anesthetic. This strategy is not recommended in patients infected with multidrug-resistant organisms or difficult to treat because of a risk of bacterial persistence on the new implant. Antibiotic pretreatment by a narrow-spectrum molecule and for which resistance acquisition is difficult might be of interest to try to reduce the inoculum and avoid contamination of the new implant.

NCT ID: NCT03721328 Completed - Clinical trials for Prosthetic Joint Infection

Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation

Start date: October 26, 2018
Phase: Phase 2
Study type: Interventional

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 treatment of PJI. Primary Outcome Measure The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.

NCT ID: NCT03717090 Completed - Clinical trials for Prosthetic Joint Infection

Rapid Diagnosis of Prosthetic Joint Infection by Matrix-assisted Laser Desorption

Start date: December 1, 2016
Phase:
Study type: Observational

This is a prospective cohort study. All patients presenting for periprosthetic joint infection and requiring debridement only or resection arthroplasty will be eligible. The synovial joint fluid will be sampled before the arthrotomy at the operation room. The purpose of this study will be to evaluate that 1) the concordance of organism identification by the direct identification of MALTI-TOF MS versus routine identification of MALTI-TOF MS and conventional cultures and 2) the timing of preliminary strain identification by the direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures in patients with periprosthetic joint infection.