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Joint Infection clinical trials

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NCT ID: NCT06293352 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection

Start date: March 2024
Phase: N/A
Study type: Interventional

In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in. There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in. We know that both the one- and two-stage revision work equally well to heal the infection, but we don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction.

NCT ID: NCT06267287 Completed - Joint Infection Clinical Trials

Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period

Start date: January 1, 2018
Phase:
Study type: Observational

Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period, determining the sensitivity of the leading pathogens to antibiotics. Materials and methods. A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection (PPI) of limb joints with microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods.

NCT ID: NCT06191601 Recruiting - Joint Infection Clinical Trials

Interest in Probabilistic Antibiotic Therapy With Broad-spectrum Beta-lactams in Orthopedic Surgery

Prob-ATB
Start date: July 17, 2023
Phase:
Study type: Observational

The management of Joint Infections (JIs) requires a medical-surgical team which includes rheumatologists, infectious disease specialists, orthopedists as well as microbiologists. This collaboration makes it possible to optimize patient care both from a functional point of view and from an infection point of view. The diagnosis of these infections is based on clinic, imaging and bacteriology (microbiological samples). Treatment is based on surgical treatment and appropriate antibiotic therapy, which will be charged only after the sample has been taken. For non-complex native septic arthritis, identification of the bacteria is expected before starting antibiotic therapy adapted to the germ. For patients requiring surgical treatment: patients with complex native joint infections (comorbidities, allergies, etc.) or joint infections on hardware, the identification of the incriminated germ(s) cannot be expected. Probabilistic antibiotic therapy is then started while awaiting the microbiological results. This antibiotic therapy generally lasts 48 hours, while the results of the antibiogram are known. If for (JIs) on native joints recent recommendations were published by the French society of rheumatology in 2020, it is not the same for (JIs) on hardware. As a result, no updated recommendations indicate the probabilistic antibiotic therapy to prescribe immediately post-operatively. Currently, the old recommendations are no longer applied regarding positive grams. Daptomycin is preferred over vancomycin. On the other hand, for gram-negative germs, broad-spectrum beta-lactams are always prescribed. The investigators are questioning the benefit of these prescriptions given the epidemiological context of joint infections and bacterial resistance phenomena. The investigators hypothesize that osteoarticular infections are mainly due to gram-positive bacteria. By affirming this hypothesis, investigators could avoid prescriptions for broad-spectrum beta-lactams. This would lead to a reduction in patient exposure to broad-spectrum antibiotics (fewer adverse effects, ecological and economic gain).

NCT ID: NCT06132347 Not yet recruiting - Joint Infection Clinical Trials

Performances of DendrisCHIP®OA in Bone and Joint Infections

DENDRIS
Start date: December 2023
Phase:
Study type: Observational

Bone and joint infections (BJI) with and without prosthetic material (knee, hip and shoulder) are complex to diagnose and treat, justifying the creation of expert centers by the French Ministry of Health (CRIOAc). In case of BJI with material, the diagnosis is based on a set of clinical, bacteriological, cytological and radiological criteria known as the EBJIS 2021 (European Bone & Joint Infections Society) criteria. For septic arthritis, diagnosis is based on bacteriology and cytology. Microbiology remains essential, and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment. Although, culture-based microbiology remains the most common diagnosis of BJI, its regular failure to identify the causative pathogen as well as its long-term modus operandi motivates the development of rapid and accurate molecular methods. The DendrisCHIP®OA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI, in less than 5 hours, with the detection of mecA resistance genes on series of 16 to 64 samples . The DendrisCHIP®OA is CE-marked and has already been the subject of an initial publication evaluating its performance in a single center. The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIP®OA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study. The study aims to include 100 patients during 6 months in five inclusion centers in the Ile de France region.

NCT ID: NCT05927311 Recruiting - Joint Infection Clinical Trials

Side Effects of Antibiotics in Bone and Joint Infections

PROSEAB
Start date: August 11, 2023
Phase:
Study type: Observational

Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.

NCT ID: NCT05804058 Completed - Joint Infection Clinical Trials

Biofilm Composition as a Predictive Biomarker for Prosthetic Joint Infection

Biofilms
Start date: July 1, 2019
Phase:
Study type: Observational

Prosthetic joint infection (PJI) represents one of the most common reasons for failure among hip and knee prostheses, with an incidence of around 1-2%. Infection can occur early (within days of surgery) or late (over a year after surgery), and no specific early markers for infection onset exist. Given the significant costs to the NHS for corrective revision surgery, the added suffering and risk to patients from surgery, and the risk of enhancing antimicrobial resistance through the use of broad-spectrum antibiotics, a more specific predictive test for early onset of infection is required.

NCT ID: NCT05753215 Recruiting - Clinical trials for Bone and Joint Infection

Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection

CORGI
Start date: May 9, 2023
Phase: Phase 2
Study type: Interventional

The study design is a randomized, open-label, clinical trial of omadacycline vs Standard of Care (SOC) antibiotics for bone and join infection (BJI) treatment. Study participants will have their BJI regimen chosen by their treating physicians, (typically Infectious Diseases for hardware and prosthetic joint infections, or multidisciplinary Limb Salvage team for diabetic foot infections) prior to enrollment. Then participants will be randomized to an omadacycline-containing regimen versus the a priori chosen SOC regimen. Participants must require between 4 and 12 weeks of therapy for their BJI. The exact duration of therapy will be decided by the participants' treating physician. At 12 weeks, if the treating physician wishes to extend therapy, participants receiving omadacycline will be transitioned to other SOC antibiotics. Once enrolled, participants will be followed via in-person clinic visits at the following intervals: weeks 0, 2, 4, 8, and 12. A final in-person visit will occur 2 weeks post-treatment completion. A phone survey will occur 3 months post-treatment completion. Participants in the SOC group will follow the same schedule. Oral once-daily dosing options for S. aureus and Coagulase negative Staphylococcus are essentially non-existent. Thus, omadacycline possesses a novel and advantageous option for BJI treatment. Its convenient dosing regimen will almost certainly be associated with improved adherence, and higher adherence may, in turn, improve clinical outcome. Investigators hypothesize that omadacycline will be a well-tolerated and efficacious oral antibiotic for BJIs and will be associated with improved adherence compared with standard of care oral antibiotics. Investigators believe omadacycline addresses the unmet need for an oral antibiotic that is well-tolerated and efficacious for use as a prolonged therapy for BJIs. To this aim, investigators will perform a randomized, open-label clinical trial of omadacycline to SOC antibiotics for BJIs.

NCT ID: NCT05519007 Recruiting - Joint Infection Clinical Trials

Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone

Start date: September 26, 2023
Phase: N/A
Study type: Interventional

A prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). The Next Science treatment arm will exhibit greater reduction in rate of 90-day post-operative joint infection than SOC (saline) arm

NCT ID: NCT05341908 Recruiting - Septic Arthritis Clinical Trials

Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients

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

This is a prospective, observational study of patients presenting to the emergency departments at 9 EMERGEncy ID NET sites. The objectives of the proposed study are to: 1. Describe the range and proportion of infectious agents in synovial fluid as detected by standard C&S and investigational PCR testing, i.e., Biofire® Film Array® Bone and Joint Infection (BJI) Panel, 2. Describe the epidemiology of patients receiving diagnostic arthrocentesis and those diagnosed with septic arthritis in the emergency department (ED), 3. Determine the prevalence of septic arthritis in US ED patients presenting with an atraumatic painful swollen joint, and 4. Determine the clinical (history and physical examination) and laboratory characteristics of septic arthritis. Study coordinators screen the ED log for adult patients presenting with joint pain and whose treating physician ordered an arthrocentesis. After confirming eligibility, study coordinators approach the patient to explain the study, and present the written consent form. If the patient agrees to participate and consent, the study coordinator completes an enrollment data collection using patient and treating physician interview to gather responses. After enrollment, the study coordinator will ensure that approximately 0.3-1.0 mL of leftover synovial fluid is saved and stored in a freezer for shipment to a central laboratory (Truman Medical Center hospital laboratory, Kansas City, MO) for testing. Approximately 30 days after enrollment, study coordinators complete an electronic medical record (EMR) review.

NCT ID: NCT05137314 Recruiting - Joint Infection Clinical Trials

Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)

Start date: March 31, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for patients with periprosthetic joint infections (PJI) after total knee arthroplasty (TKA) .