View clinical trials related to Bone Infection.
Filter by: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.
The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Composition and diversity of the microbiome will be assessed by 16sRNA sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto Mannitol-salt-agar plates supplemented with rifampicin, inflammation markers and antibodies in blood and saliva are monitored to track changes in the immune response. For further analysis patients are assigned to one of two groups: 1) antibiotic therapy including rifampicin and 2) non-rifampicin antibiotic therapy.
This is a prospective study. Patients' cohort is composed of 70 consecutive post joint replacement and post tibial ORIF patients, referred by their orthopedic surgeon to the Nuclear Medicine institute of Tel Aviv Sourasky Medical Center in the diagnostic work up of post operative bone infection and or mechanical loosening. The proposed study will be presented to the ethical committee of the medical center and will be started once approved.
This project aims to produce synthetic bone tissue graft that supports bone regeneration and combats infection simultaneously, according to industry standards and regulations. This original and high value added biomaterial "silver doped calcium phosphate based synthetic bone tissue " will be used in clinical trials in patients with osteomyelitis and implant-related infections for the treatment. Chronic bone infections are one of the most important problems in orthopedic surgery and are not just a problem of developed societies. When open fracture cases, which may get infected in 1-50%, implant-related infections and diabetic foot ulcer cases are taken into consideration, osteomyelitis will be seen as a very common problem all over the world. Multiple surgeries, long-term use of antibiotics and the high costs affects all societies. The use of synthetic bone grafts is growing faster than the natural bone grafts in the world. USA has spent 246 million US dollars for the use of synthetic bone graft in 2010. For the treatment of bone infections antibiotic impregnated synthetic bone grafts with different characteristics are used. Although these antibiotic impregnated synthetic bone grafts are superior compared to antibiotic bone cement with the implementation of different antibiotics and to be absorbable but they cannot show optimum benefit because the release of antibiotics is not due to host matrix degradation but diffusion control. The other issue to be considered as this regard that the development of microbial resistance to these antibiotics which is also a serious problem. Innovative synthetic bone graft with better contribution of the needs of mechanical properties, depending on the applied bone region, optimized antimicrobial activity and bone tissue regeneration are needed. In this study, it will be determined whether this silver ion -doped antimicrobial synthetic bone graft that has the capacity to fill the bone voids that may occur in chronic bone infection during disease process or after surgical debridement, also has the capacity to treat the infection in the bone will be used in 12 patients who had been diagnosed as chronic osteomyelitis to see if it cause any unwanted side effect in normal usage conditions and generates unacceptable risks. Clinical, laboratory and radiological investigations will be used to demonstrate the healing of the infections and the cavities in the bone. Blood and urine levels of silver will be detected from patients. Antimicrobial activity of silver is well-known. The effectiveness of the silver and potential toxicity is related to the dose of silver and application form. In orthopedics, the use of silver is mostly limited to elemental silver coating of metal implants. There is no biotechnologic approach manufactured silver ion -doped calcium phosphate -based synthetic bone graft in the health sector yet. Ionic silver has advantages such as low toxicity, no tolerance of silver against bacteria, and strong antibacterial activity. The trapping of silver ions in the calcium phosphate based ceramic structure overcomes the other systems with its controlled release and its ability to be effective at minimum doses. The project is an original work since it will contribute to bone regeneration while at the same time removing the infection.
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 prolonged suppressive antibiotic therapy 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 just to constitute a biological collection from samples from the Gut microbiota 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.
Because of its prolonged terminal half-life, dalbavancin is an extremely attractive option in treating Gram-positive infections caused by S. aureus including MRSA, and streptococcal species. Systemic bacterial infections due to Staphylococci such as osteomyelitis and septic arthritis, are conditions which require prolonged IV therapy, typically for at least 3-6 weeks, though sometimes more. Due to dalbavancin's prolonged terminal half-life, it may offer the opportunity to substantially reduce costs and morbidity in native joint and prosthetic joint infections with one infusion every fourteen days until completion of therapy.
For patients having a bone or joint infections, with or without device, optimal surgical therapy 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. Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way when oral treatment is not available to facilitate ambulatory care, this practice being considered as routine care. The aim of this study is to evaluate tolerance and efficacy of subcutaneous administration of antibiotics for prolonged suppressive antibiotic therapy in patients having this treatment as part of their routine care.
Due to the emergence of multidrug-resistant micro-organisms in patients with bone and joint infection (BJI), the prescription of off-labeled antibiotics seem to be more and more common as part of routine care. These new antibiotics are, however, more expensive, and there are no precise data in France regarding the volume and cost of such off-label prescriptions in hospital, in the post-acute care structures, and in the outpatient setting. The objective of this study is to estimate the cost of using these antibiotics over 2 years for patients in a reference center for the management of complex bone and joint infection (CRIOAc)
Daptomycin is validated as a treatment of bone and joint infections by the Infectious Disease Society of America. However, most of studies did not investigate daptomycin pharmacokinetics in this indication while it is known that efficacy and toxicity concentration studies show a close therapeutic margin. Evaluation of P-Glycoprotein (P-gp), a transmembrane transport protein, has demonstrated its influence on the concentration and intracellular activity of daptomycin. Recent work has linked the genetic polymorphism of P-gp to the pharmacokinetics of daptomycin, which may explain inter-individual variability but requires further explorations. Previous studies demonstrated existence of interindividual variabilities as sex, renal function and p-glycoprotein polymorphism couple with an intraindividual variabilities unexplained yet. A population approach will be used to determinate the pharmacokinetics factors, their intra and interindividual variabilities, the parameters associated to those variabilities (as the p glycoprotein). The investigator's goal is to evaluate different posology and to try to increase daptomycin efficacy and security in bone and joint infection.
Retrospective observational study: Soft tissue and bone diameters are assessed in MRI and CT scans of patients. Data is compared with recommendations of intraosseus needle producers to assess whether the information provided by the producers can be optimised. Study sites are head of humerus bone, distal femur, proximal and distal tibia in accordance with recommended intraosseus access sites. Primary and secondary outcome parameters will be assessed at one time only, i.e. when the patient has received MRI or CT scan for the diagnostic work up of their primary disease. Data collection for a given patient in this study can be completed within one session, e.g. 5-10 minutes. No additional investigation is required for this retrospective study.