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Bone and Joint Infection clinical trials

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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: 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: NCT04538053 Recruiting - Osteomyelitis Clinical Trials

BonE and Joint Infections - Simplifying Treatment in Children Trial

BEST
Start date: June 1, 2021
Phase: Phase 4
Study type: Interventional

This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.

NCT ID: NCT04496024 Recruiting - Clinical trials for Bone and Joint Infection

Ofloxacin Concentration-toxicity Relationship in the Elderly

ROSCO
Start date: June 2, 2020
Phase: N/A
Study type: Interventional

Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to sensible staphylococcus strains. However, in the elderly, inter-individual variability of the pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin side effects is likely to be increased in case of higher exposition. However, the serum concentration-toxicity relationship has not yet been determined. The purpose of this project is to assess the association between the residual serum concentration of ofloxacin at day 3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.

NCT ID: NCT04414137 Recruiting - Clinical trials for Bone and Joint Infection

Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin

Start date: February 19, 2019
Phase:
Study type: Observational

Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria. Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide. The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future

NCT ID: NCT03796104 Recruiting - Clinical trials for Staphylococcus Aureus

Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR

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

The aim of this study is to determine if delta-haemolysin production deficiency of Staphylococcus aureus is a marker in favour of chronic infections on implants

NCT ID: NCT03611634 Recruiting - Clinical trials for Bone and Joint Infection

Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine

Start date: July 19, 2018
Phase:
Study type: Observational

Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection [PJI]) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as PSAT could be a convenient way to limit catheter-related complications and facilitate ambulatory care. However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine. The aim of this study is is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.