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Bone and Joint Infection clinical trials

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NCT ID: NCT05977868 Enrolling by invitation - Clinical trials for Bone and Joint Infection

Comparing Oral Versus Parenteral Antimicrobial Therapy

COPAT
Start date: August 4, 2023
Phase: Phase 4
Study type: Interventional

This is an investigator initiated multisite pragmatic randomized controlled trial designed to demonstrate equivalent effectiveness with improved safety of early transition from intravenous (IV) antimicrobial therapy to complex outpatient oral antimicrobial therapy (COpAT) across various infectious diseases (endovascular, bone and joint, skin and soft tissue, pulmonary, gastrointestinal, and genitourinary infections). All patients referred for outpatient parenteral antimicrobial therapy (OPAT) will be evaluated by the research team with respect to inclusion/exclusion criteria. If determined eligible for enrollment, patients will be approached by a study investigator who will present the COPAT Trial. Once informed consent is obtained, patients will be randomized 2:1 using computer software into experimental or control (standard of care) group, respectively: Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, OPAT transitioned to COpAT later in outpatient setting, or long-acting parenteral lipoglycopeptides. Both groups will be followed by an ID physician on the research team with in-person or telemedicine ID Clinic standard of care visits at 2, 6, and 12 weeks after hospital discharge. At the 6-week ID Clinic follow-up, patients will be asked to complete a patient satisfaction survey. The following 2 primary outcomes will be assessed: cure at 3 months using clinical (resolution of infection) and laboratory parameters (improvement in inflammatory markers) and adverse events related to antimicrobial therapy/vascular access complication. The following 3 secondary outcomes will be assessed: overall readmission at 3 months, readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months, and patient satisfaction at 6 weeks. The experimental group is being compared to standard of care in current clinical practice. As this is a pragmatic clinical trial, patients will not undergo additional invasive testing or procedures.

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: NCT05421312 Not yet recruiting - Pharmacokinetics Clinical Trials

Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip

CONCENTRATE
Start date: September 2022
Phase: Phase 4
Study type: Interventional

To prevent periprosthetic joint infection (PJI), optimal penetration of antibiotics into the joint-space is needed. In revision arthroplasty, the incidence of PJI is increased compared to primary arthroplasty. In this study, the penetration of antibiotic agents into the synovial fluid and bone will be analyzed. The concentration of antibiotics will be related tot the to the susceptibility (minimal inhibitory concentration; MIC-90) of microorganisms that frequently cause PJI.

NCT ID: NCT05248490 Completed - Clinical trials for Bone and Joint Infection

Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home

EFIRAD
Start date: March 22, 2022
Phase: N/A
Study type: Interventional

The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home.

NCT ID: NCT04933344 Recruiting - Clinical trials for Bone and Joint Infection

Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

PKTOXDAP
Start date: June 15, 2021
Phase:
Study type: Observational

the aim of this study is to investigate the relationship between exposure to daptomycin and the occurrence of muscle toxicity or eosinophilic pneumonia in patients treated with daptomycin for bone and joint infection

NCT ID: NCT04724603 Recruiting - Clinical trials for Prosthetic Joint Infection

Phage Safety Retrospective Cohort Study

PHASACO-retro
Start date: February 1, 2021
Phase:
Study type: Observational

The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.

NCT ID: NCT04722926 Recruiting - Clinical trials for Bone and Joint Infection

Lyon PJI Retrospective Cohort Study

Start date: January 10, 2022
Phase:
Study type: Observational

Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs. This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.

NCT ID: NCT04712123 Recruiting - Clinical trials for Bone and Joint Infection

Recurrent S. Aureus Infections in Osteoarticular Infections

RELAPSTAPH
Start date: August 1, 2021
Phase:
Study type: Observational

Staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. Currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side. The aim of this study is to improve knowledge on persistence of mechanisms of S. aureus

NCT ID: NCT04662736 Completed - Clinical trials for Bone and Joint Infection

Tedizolid Suppressive Antimicrobial Therapy in a Reference Center

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

the aim of the study is to describe the management and outcome of patients having an osteo-articular infection treated by tedizolid as a suppressive antibiotic therapy.

NCT ID: NCT04625478 Completed - Clinical trials for Bone and Joint Infection

Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections

CRISBO
Start date: December 1, 2020
Phase:
Study type: Observational

Different mechanisms have been proposed to explain the pathophysiology of chronic staphylococcal BJI, including biofilm formation and the ability of staphylococci to be internalized and to survive within cells. The intracellular localization of staphylococci is well documented by in vitro studies, however, few studies have shown the presence of intracellular staphylococci in clinical specimens from patients with BJI. The aim of the CRISBO study is to document the clinical relevance of intracellular staphylococci in the context of BJI. Immunostaining targeting staphylococci and components will be carried out on tissue samples taken from patients with BJI during their treatment (samples similar to those used for routine diagnosis in pathology). Our objectives are to identify whether intracellular staphylococci are observable in these samples and if so, in which cell type (s) are they housed.