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Arthritis, Infectious clinical trials

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NCT ID: NCT03011502 Completed - Clinical trials for Bone and Joint Infection

InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

OSIRIS
Start date: December 2016
Phase: N/A
Study type: Interventional

Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation. As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). These patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea. MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI). The objective of this study is to follow patients with treated BJI in order to characterize intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota Transplantation (aFMT) intervention. To do this, patients will be monitored according to the current CRIOAc recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. Only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution. Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.

NCT ID: NCT03009045 Completed - Clinical trials for Bone and Joint Infection

Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections (OTTER)

Start date: February 6, 2017
Phase: Phase 2
Study type: Interventional

The problem of interest is that doctors are looking for new antibiotic treatments for bone and joint infections. Treatment for bone and joint infection is not standardized, which allows a wide range of antibiotic therapy to potentially be given. A type of bacteria called S. aureus is the most common cause of bone and joint infection. Methicillin resistant S. aureus (MRSA) is a type of bacteria that is not killed by some antibiotics, and it is increasingly common in U.S. and non-U.S. medical centers. This problem will be studied by investigating whether an antibiotic called tedizolid is tolerable, safe and effective to treat bone and joint infections.

NCT ID: NCT02860871 Completed - Joint Effusion Clinical Trials

Use of Infrared Spectroscopy in Septic Arthritis Diagnosis

SynoFAST
Start date: June 2014
Phase: N/A
Study type: Observational

The main objective of this study is to assess the ability of Fiber-optic Evanescent Wave Spectroscopy (FEWS) to discriminate synovial fluids samples of septic arthritis patients from other causes of joint effusion by analyzing ex vivo joint fluid samples collected during routine clinical care.

NCT ID: NCT02806063 Completed - Clinical trials for Prosthetic Joint Infection

Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection

Bac-UP
Start date: April 2016
Phase: N/A
Study type: Interventional

Chronic prosthetic joint infection (PJI) is a devastating complication of arthroplasty and its treatment continues to fuel the debate on how to manage it appropriately. One stage and two stage exchange surgery both are the conventional surgical procedures for chronic PJI commonly used to date. Two stage surgery disadvantages (major surgery, anesthesia and nosocomial risks, functional impairment between surgeries and a high socio-economic coast) encouraged many surgical teams to adopt one stage exchange surgery which provides equivalent or better outcomes. However one stage surgery encounters a major conceptual difficulty when it comes to implant the new prosthesis in a surgical site microbiologically undetermined and potentially contaminated. Investigators suppose the new prosthesis is implanted in a contaminated setting regardless of bacteria type and antibiotic therapy duration before arthroplasty. The total lack of data answering this question motivated the conception of this prospective study in order to describe the microbiological setting where is implanted the new prosthesis with one stage exchange surgery after surgical excision and antibiotic therapy initiation in chronic PJI.

NCT ID: NCT02629770 Completed - Clinical trials for Bone Diseases, Infectious

Clindamycin-rifampin Drug Interaction in the Treatment of Bone and Joint Infections

CLIRIFA
Start date: December 2015
Phase:
Study type: Observational

Treatment of bone and joint infections remains difficult and variable according to centres and countries. Clindamycin given intravenously and followed by an oral route is recommended for the treatment of staphylococcal, streptococcal and anaerobes bone and joint infections by the French Society for Infectious Diseases. For staphylococcal bone and implant infections, rifampin is a major drug, as it remains active in bacterial biofilm and on quiescent staphylococci. For that reasons, clindamycin-rifampin combination therapy is frequently used in these infections.Clindamycin is metabolized by the P450 3A4 cytochrome, an enzyme strongly inducible by rifampin. A retrospective study published in 2010 on 70 patients treated for bone and joint infections showed that clindamycin serum concentrations were significantly lower when clindamycin was combined with rifampin (5.3 mg/liter vs 8.9 mg/liter; p<0.02). This drug interaction could even be stronger with the oral route, because of hepatic first-past effect, ending up with very low clindamycin serum concentration, a risk of selecting resistant microorganisms and treatment failure. This latter point is an important issue, because clindamycin has an excellent oral bioavailability and is frequently used in oral regimens. In the above study, a wide variability of clindamycin serum concentration was observed in the group of patients treated with combination therapy (1-12mg/l) suggesting interindividual variability. Rifampin induction of CYP 450 3A4/A5 depends on different receptor (PXR, RXR, LXRalpha) submitted to genetic polymorphism. Hypothesis: Plasma clearance of clindamycin (CLclin) combined with rifampicin (CLclinrif) is higher when clindamycin is administered by the oral route (CLclinrif OR) compared with IV administration (CLclinrif IV).

NCT ID: NCT02569541 Completed - Clinical trials for Refractory Bone or Joint Infections

Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections

Start date: December 2015
Phase: Phase 2/Phase 3
Study type: Interventional

To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.

NCT ID: NCT02508584 Completed - Infection Clinical Trials

Personalized Immunotherapeutic for Antibiotic-resistant Infection

Start date: April 12, 2016
Phase: Early Phase 1
Study type: Interventional

M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. The investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB Biotherapeutics), purify human antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.

NCT ID: NCT02505828 Completed - Clinical trials for Juvenile Idiopathic Arthritis

ARTEMIS Synovial Markers in Arthritis Childhood

ARTEMIS
Start date: April 2015
Phase: N/A
Study type: Interventional

The aim of this study is to find markers that could differentiate infectious and inflammatory arthritis. The investigators want to find markers by differential analysis by compare synovial fluids of septic and inflammatory arthritis. The investigators will use for this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The investigators will use one marker or a score with biological and clinical data to discriminate arthritis of infectious and inflammatory etiology.

NCT ID: NCT02413034 Completed - Clinical trials for Prosthetic Joint Infection

The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures

Start date: November 2013
Phase: N/A
Study type: Interventional

Total joint replacement is a common clinical practice for patients suffering from disabling arthritis, since it provides significant pain relief and functional recovering. Nevertheless, its outcome is compromised by complications such as periprosthetic joint infection (PJI), which is reported to occur in 1 to 4% of primary total knee arthroplasties (TKA), and approximately 1% of primary total hip replacements (THR). Despite all efforts to restrain PJI, its prevalence may reach even higher proportions if patients undergo a resection arthroplasty or irrigation and débridement for infected prosthesis. That said, timely diagnosis and early isolation of the infected microorganism is utterly important, if proper care is to be delivered. The gold standard for the diagnosis of PJI is the isolation of a microorganism from the intraoperative cultures, combined with the sonication from retrieved joint implants1. This technique applies sound energy to agitate and disrupt biofilm, dislodging adherent bacterias to the bone cement, which has been proved to be a more sensitive method than conventional intraoperative cultures. False-negative percentages were reported to be 15% in patients who did not receive extended antibiotic prophylaxis and 60% if extended antibiotic therapy was administered. Regardless of an adequate clinical, radiographic and surgical suspicion confirming PJI, an organism is not always successfully isolated from the intraoperative cultures, which increases false negatives results. This fact has been trying to be explained by several authors, some of which postulate that antibiotic prophylaxis could interfere with the isolation of the microorganism from the intraoperative cultures. As a result, and acting accordingly to this hypothesis, preoperative antibiotics are often withheld until intraoperative cultures are obtained, hoping that tissues are not loaded with antibiotics. Nevertheless, one should be aware of the adverse consequences of this practice that may result in systemic dissemination of infection. Moreover, Ghanem and Stephen recently concluded that antibiotic prophylaxis does not interfere with the isolation of the microorganism from intraoperative cultures, despite being studies that lack statistical power. Therefore, it is clear that reported studies in this field support both preoperative antibiotic prophylaxis administration, as well its withdrawal, until intraoperative cultures are obtained. This decision in the department study depends exclusively on the treating surgeon judgment. In fact, 48% of all patients admitted at the study hospital with PJI receive preoperative antibiotic prophylaxis, which could be related to higher false-negative intraoperative culture and sonication results. Thus, the investigators add substances with chelation properties to hemoculture containers and then inoculate sonication samples. This practice offsets antibiotic interference with intraoperative cultures and has proved to enhance microorganism detection rates. That said, and given the lack of scientific evidence about this clinical practice the investigators are willing to engage a prospective randomized double-blind clinical trial, that will allow us to determine whether intraoperative cultures and sonication samples are affected by antibiotic prophylaxis.

NCT ID: NCT02085733 Completed - Clinical trials for Arthritis, Infectious

Pro-calcitonin for Early Detection of Septic Arthritis

Start date: February 2014
Phase:
Study type: Observational

Background: Children presenting with non-traumatic joint pain require different treatment depending on the cause of pain. Septic arthritis, which results from a bacterial infection in the joint, often requires a surgical procedure as well as a long course of antibiotics. In contrast, non-septic arthritis is typically treated by management of symptoms and observation. Current diagnostic standards involve microbiologic examination of fluid taken from the affected joint. This procedure can require the patient to be sedated, and the fluid culture analysis can take up to 72 hours. A single laboratory measure that could be easily obtained and quickly analyzed would aid in faster diagnosis, fewer diagnostic tests and lower cost of the diagnostic work-up for this condition. Recent research on septic arthritis has identified procalcitonin as a potential septic arthritis diagnostic indicator. Procalcitonin (PCT) is secreted by cells in the thyroid at higher levels when the body is facing infection. Procalcitonin levels rise slowly over the first two hours and peak at 24 hours. Levels rise 100-fold in the peripheral blood stream during this time frame. Several studies have indicated PCT is promising potential diagnostic indicator for septic arthritis. Unfortunately, many of these studies have relatively small sample sizes and very few involve pediatric populations. Additional study of PCT and septic arthritis in children will help evaluate the viability of PCT as a diagnostic indicator. Research Question: Can serum procalcitonin assist in clinical differentiation between bacterial (septic) and non-bacterial arthritis? Methods: Patients presenting with possible septic arthritis in the emergency department will be recruited for this study. Patients who consent to participate will receive the current standard for care, including IV placement, laboratory tests for Erythrocyte sedimentation rate (ESR),white blood cell count (WBC), and C-reactive protein (CRP), x-rays and consultation with pediatric orthopedics. Patients participating in the study will have a portion of the serum collected for typical diagnostic tests analyzed for PCT. Research assistants will collect data from medical records of participants, including lab and imaging results. Patients who do not undergo surgery will be contacted by phone within 7 days of their ED visit to confirm diagnosis.