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Prosthetic Joint Infection clinical trials

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NCT ID: NCT04650607 Recruiting - Clinical trials for Prosthetic Joint Infection

Phage Safety Cohort Study

PHA-SA-CO
Start date: May 9, 2022
Phase:
Study type: Observational

This cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.

NCT ID: NCT04620395 Recruiting - Clinical trials for Prosthetic Joint Infection

Percutaneous Punch Biopsy for Diagnosis of Septic and Aseptic Prosthetic Joint Failure

SHARP
Start date: August 20, 2020
Phase: N/A
Study type: Interventional

The aim of the superiority study is to establish a reproducible, minimally invasive, cost-effective way of sample collection for microbiological and pathomorphological processing in a clinical setting with avoidance of anesthesia, multiple punctures, as well as potential deep contamination during irrigation.

NCT ID: NCT04488458 Recruiting - Clinical trials for Prosthetic Joint Infection

Susceptibility Testing of Biofilm to Guide Treatment of Periprosthetic Joint Infections

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

The overall purpose of this clinical treatment research project is to explore novel diagnostics that can guide the treatment of infections associated to orthopaedic implants, in order to improve patient outcomes and reduce the development of antibiotic resistance. The project aims are: (i) To improve the current diagnostic approaches and treatments of periprosthetic joint infections (PJI) (ii) To investigate the pathogenesis of PJI through the characterization of the virulence carried by the causative pathogens This multidisciplinary project addresses implant-associated infection and its contribution to increasing antibiotic resistance. Both lead to longer hospital stays, higher medical costs and increased morbidity and mortality. Antibiotic resistance is globally considered as one of the greatest and most urgent risk in medicine. Implant-associated infections are commonly caused by biofilms. Biofilms can be described as 'a community of bacterial cells connected by their secreted extracellular matrix'. Since antibiotics are designed to fight planktonic free-living bacteria, studying antibiotic resistance in biofilm communities poses a paradigm shift. Furthermore, bacteria in biofilms are up to 1000 times more resistant to antibiotics than planktonic bacteria. Mechanisms involved in a biofilm infection also play a crucial role in the development of antibiotic resistance. Hospital-acquired infections are the fourth leading cause of disease and 70% are associated with medical implants and caused by staphylococcal biofilms. In addition, the level of antimicrobial resistance in bacteria causing implant-associated infections has increased worldwide, leaving patients with fewer treatment options. In this study the investigators will randomize patients with PJI to either standard MIC susceptibility or MIC and MBEC susceptibility guided treatment with oral antibiotic combinations; (i) Non cell wall active standard of care antibiotic combination (MIC-guided) for 6 weeks. (ii) Or; non cell wall active antibiotic combination according to a MBEC-based decision algorithm for 6 weeks. In this pilot project, the primary endpoint is how often treatment changes with the MBEC susceptibility testing compared to only MIC-susceptibility testing.

NCT ID: NCT03826108 Recruiting - Clinical trials for Arthroplasty Complications

ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)

Start date: April 16, 2019
Phase:
Study type: Observational

The number of arthroplasties is expected to grow in the next few years. Staphylococcus aureus (SA) is a primary cause of prosthetic joint infection (PJI) with serious consequences. This microorganism is frequently associated with treatment failure, hospitalizations and need of prosthesis removal, leading to an important morbidity and an increase in healthcare costs. ARTHR-IS is a retrospective multi-center study which aims to estimate the burden of SA-PJI after a hip or knee arthroplasty and their risk factors. Other objectives are to quantify the costs, the number of hospitalizations and the surgical procedures needed to treat and control the infection and finally the factors influencing therapeutic failure. Through a case-control design, ARTHR-IS will group 20 hospitals across 5 European countries in order to include 150 cases and 450 controls. The results of this study will provide critical information to develop strategies to prevent and treat SA-PJI and reduce treatment failures. Also, the results from ARTH-IS study will help in the design of future clinical trials in prosthesis infections by providing reliable estimates on the incidence of SA-PJI and the subsequent burden on health care services.

NCT ID: NCT03784807 Recruiting - Clinical trials for Prosthetic Joint Infection

New Strategies for Biofilm Related Infections

Diafilm
Start date: November 2, 2018
Phase:
Study type: Observational

This study aims to develop new assays for synovial fluid analysis able to improve diagnosis of prosthetic joint infections. In particular, use of synovial calprotectin as marker of infection, confocal laser scanning microscopy (CLSM) analysis and methods to assess antimicrobial susceptibility will be evaluated in synovial fluids collected from patients with septic and aseptic failure of the prosthetic implant.

NCT ID: NCT03714165 Recruiting - Clinical trials for Prosthetic Joint Infection

Alpha Defensin and 16S rRNA Gene in Diagnosis of PJI

Start date: January 1, 2019
Phase:
Study type: Observational

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 catastrophic results and requiring repeated and extensive treatment. The incidence of PJI (a prosthetic joint infection) varies depending on the joint involved; the rate of arthroplasties becoming infected is as follows: 1.7% of primary and 3.2%of non-primary hip arthroplasties. The accurate diagnosis of prosthetic joint infection often involves the combination of multiple factors including symptoms, signs, synovial fluid cell count, serum inflammatory markers, and culture. The sensitivity of synovial fluid culture is only 85%, so a negative culture does not rule out infection. However, the specificity of synovial fluid culture is approximately 95%, and positive cultures often imply the presence of prosthetic joint infection. The synovial fluid alpha-defensin test is an immunoassay that was specifically developed to aid in the diagnosis of prosthetic joint infection . The sensitivity and the specificity of the alpha-defensin immunoassay test have been reported to be above 96%. Molecular diagnostic tests using polymerase chain reaction (PCR) are emerging as a tool for the diagnosis of infections and noninfectious conditions. The application of PCR techniques with primers derived from the highly conserved regions of the bacterial 16S rRNA gene has been useful in the detection of bacterial organisms. Use of broad-range 16S rRNA gene PCR as a tool for identification of bacteria is possible because the 16S rRNA gene is present in all bacteria . Aim of the work: .Determine sensitivity and specificity of alpha defensing and 16S rRNA gene in diagnosis of prosthetic joint infection. - Detection of antibiotic sensitivity for different organisms isolated from synovial fluid

NCT ID: NCT03307109 Recruiting - Quality of Life Clinical Trials

Quality of Life in Patients Having a Prosthetic Joint Infection

QuaVIPA
Start date: October 17, 2017
Phase:
Study type: Observational

Bone and joint infections (BJI) are rare serious pathology which can lead to a very heavy handicap and sometimes to the life threatening. These are devastating diseases whose diagnosis is difficult. They are known to be associated with high mortality rates (5%) and significant morbidities responsible for functional sequelae (40% of patients) with an individual cost (prolonged hospitalization, altered quality of life) and societal (work stoppage, partial or total disability, temporary or permanent) extremely high. These bone and joint infections have a significant impact on the quality of life of those affected who, in addition to their infection, are reduced in their autonomy and often need to be taken care of outside their home, sometimes away from home. To the knowledge of investigators, there are few studies on the measurement of quality of life in patients with osteoarticular infection. The aim of this study is to implement the EQ-5D-3L validated quality of life questionnaire and the EVA scale (created by EuroQol Group) for each patient with a prosthetic joint infection (IPA) on prosthesis during their medical care in the department of Infectious and Tropical Diseases.

NCT ID: NCT03260010 Recruiting - Clinical trials for Prosthetic Joint Infection

Efficacy and Safety of Intravenous Fosfomycin in Prosthetic Joint Infection

PROOF
Start date: January 15, 2018
Phase: Phase 4
Study type: Interventional

The PROOF Study is an open prospective interventional non-randomized study which aim is to determine the outcome / effect and safety of fosfomycin in patients with hip, knee or shoulder PJI.

NCT ID: NCT02805803 Recruiting - Clinical trials for Prosthetic Joint Infection

Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.

PSA-QOL
Start date: November 9, 2016
Phase: N/A
Study type: Interventional

Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement when symptoms duration is greater than 30 days or debridement with modular set replacement when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients and those who refuse reoperation. There is limited data available on PSA modality, its tolerance and efficacy, this lack of data motivated us to concept a prospective study of long term patient follow up with PJI treated with prolonged suppressive antibiotherapy.

NCT ID: NCT02801253 Recruiting - Clinical trials for Prosthetic Joint Infection

Cohort of Prosthetic Joint Infections

COPINS
Start date: September 11, 2015
Phase:
Study type: Observational

Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing. Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a high operative risk prolonged suppressive antibiotic therapy can be used. Lack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to PJI management procedures.