Septic Arthritis

This research aims to compare how well two diagnostic methods—percutaneous aspiration and open biopsy—detect infections in shoulder and elbow joint replacements that need revision surgery. Periprosthetic joint infection (PJI) is a serious problem leading to many revision surgeries, and early, accurate diagnosis is crucial but challenging. The study focuses on improving diagnosis methods specifically for shoulder and elbow PJI, as current evidence mainly comes from hip and knee replacements. The study observes patients undergoing revision surgery after shoulder or elbow arthroplasty. It compares the accuracy of pre-operative joint aspiration, which collects fluid samples, against open biopsy, which obtains tissue samples during surgery. Both microbiological and histological tests will be used to assess infection presence. The study follows participants for up to 36 months to evaluate the diagnostic accuracy of these methods. Participants will undergo standard clinical assessments, including laboratory tests of blood and joint fluid, microbiological cultures, tissue analysis, and imaging. Researchers will track infection detection and compare results from aspiration and biopsy samples. The main outcome is the diagnostic accuracy over 36 months, with additional culture analysis completed within 14 days. The study does not involve experimental treatments but focuses on improving infection detection before surgery.

Researchers are studying participants with early or acute hematogenous periprosthetic joint infection (PJI) following total knee arthroplasty (TKA) or other joint replacement surgeries. The study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of TNP-2092 given by intra-articular (IA) injection alongside vancomycin intravenous (IV) and oral antibiotics. This Phase 1/2, randomized, controlled, open-label study explores treatment options for PJI patients requiring or not requiring debridement, antibiotics, and implant retention (DAIR) therapy or long-term antibiotic suppression. Participants are assigned to one of four groups: a sentinel group receiving TNP-2092 IA plus vancomycin IV and oral antibiotics, an experimental group receiving the same, a control group receiving vancomycin IA plus vancomycin IV and oral antibiotics, or an expansion group receiving TNP-2092 IA based on background treatment. TNP-2092 is administered at 50 mg via IA injection once daily for 14 days, with dose adjustments allowed based on drug concentrations and safety. Oral antibiotic treatment lasts 8 weeks, and vancomycin IV and IA are given daily for 14 days. Participants undergo screening assessments within 7 days before starting the study and must agree to hospitalization for 2 weeks of IA injections. Researchers will monitor safety by tracking adverse events through Day 187 and measure TNP-2092 concentrations in synovial fluid and plasma at multiple time points. They will also assess treatment responses at Day 14 and study end, along with treatment failure within 6 months. The study involves regular blood tests and clinical evaluations to evaluate the treatment's pharmacokinetics and local and systemic effects.

Researchers are studying the experiences of people who develop rheumatic immune-related adverse events (irAEs) after receiving immune checkpoint inhibitor immunotherapy. This study aims to understand how severe these events are, how they affect daily function, and the attitudes of patients towards different aspects of these side effects. The research focuses on conditions like arthritis and polymyalgia rheumatica that arise following this cancer treatment. This observational study does not involve any drug or treatment interventions. Instead, it gathers information through qualitative assessments from patients diagnosed by rheumatologists with inflammatory arthritis or polymyalgia rheumatica as irAEs after immune checkpoint inhibitor therapy. The study is sponsored by M.D. Anderson Cancer Center and will collect data over about one year. Participants will engage in interviews to share their experiences, which will help researchers evaluate the safety and adverse events associated with these immune-related conditions. The study includes monitoring adverse events throughout the study period. The total involvement duration averages one year, allowing for comprehensive understanding of the impact and progression of these rheumatic irAEs.

Researchers are evaluating the long-term outcomes of the ACE Acetabular Cup System, a device used in total hip replacement surgery. This procedure replaces both the hip ball and socket to relieve pain and help patients return to normal activities. The study aims to monitor the safety and performance of this CE-marked device over 10 years by assessing clinical, functional, and radiological results in patients with hip disease. The ACE Acetabular Cup System offers three options for socket liners: ceramic, polymer, or dual mobility, allowing surgeons to choose the best fit for each patient. Participants in the study have received a primary elective total hip replacement using this system combined with a JRI femoral stem and head. The study is observational and follows patients over a decade to gather data on device function and patient health. Participants will be followed through questionnaires, reviews of X-rays, and monitoring of any complications. Key measurements include the Oxford Hip Score at 3 years post-operation, along with implant survivorship and other hip function assessments at multiple time points up to 10 years. Radiological assessments will also be conducted at 1, 5, and 10 years. This comprehensive follow-up helps researchers understand how well the device performs long-term and supports patient safety.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Sepsis is a serious condition caused by the body's uncontrolled response to infection, which can lead to septic shock, a life-threatening state. This research evaluates whether adding fludrocortisone to the standard treatment with hydrocortisone might improve outcomes for critically ill patients in shock. The study is a Phase II pilot trial designed to test the feasibility of a larger international study that would confirm if this combination therapy can reduce mortality in septic shock. The trial is a randomized, double-blind, placebo-controlled study conducted in six intensive care units across Hong Kong, Australia, and Singapore. Participants will receive either 100 mcg of enteral fludrocortisone daily or a placebo for up to seven days, alongside standard intravenous hydrocortisone given every six hours. The treatment period lasts until discharge from the ICU or death, whichever occurs first. Participants will be critically ill adults who have septic shock and require mechanical ventilation. Researchers will monitor protocol adherence, recruitment rates, time to shock resolution, mortality at 28 days, days free of organ support, and severe electrolyte imbalances. The study includes detailed tracking of feasibility outcomes, data completeness, and safety over approximately 20 months, with the aim of informing a larger future trial.

Researchers are studying how to better identify septic arthritis, a serious joint infection in children, by testing several proteins in joint fluid. Diagnosing septic arthritis early is crucial because it requires surgery to prevent permanent joint damage. The current gold standard diagnosis is a positive joint fluid culture, which takes days, so quicker tests like the alpha-defensin assay are being evaluated for their accuracy in detecting infection in children under 18. This study compares joint fluid from children suspected of having joint infections or inflammation with samples from children undergoing unrelated procedures without infection. Various tests will be performed on the joint fluid, including alpha-defensin, leukocyte esterase, neutrophil elastase, C-reactive protein, lactate, and several bacterial and fungal antigen panels. Blood tests will also be done to measure markers of infection and inflammation. Results from these experimental tests will be compared to the standard joint fluid culture. Participants will have one study visit during their standard care procedure involving joint fluid sampling. Researchers will analyze the sensitivity and specificity of these tests to see how well they detect bacterial infection. The study will include children up to 17 years old and will provide important information to help diagnose septic arthritis faster and more accurately in pediatric patients.

Influenza infection poses a significant public health challenge due to seasonal outbreaks and pandemics causing widespread illness and death. This study focuses on hospitalized neonates and infants under 6 months of age with complicated influenza infection, a group with limited treatment options because their immune systems are immature and no licensed vaccines exist for this age. The study aims to evaluate the pharmacokinetics (PK), safety, and tolerability of intravenous (IV) zanamivir in this vulnerable population as part of a Pediatric Investigation Plan by GlaxoSmithKline. Participants who are hospitalized neonates and infants under 6 months, including preterm infants with at least 28 weeks post-menstrual age, will receive daily IV zanamivir infusions for up to 5 days. Depending on clinical symptoms, participant condition, or virological tests, this initial treatment may be extended for up to 5 additional days. The dosing is individually determined based on corrected age, body weight, and renal function, with the initial dose followed by twice-daily maintenance doses as guided by the principal investigator. Each participant will be involved in the study for up to 24 days, including a treatment period of up to 10 days and a 14-day post-treatment follow-up. Researchers will collect blood samples to measure zanamivir levels at various time points, monitor viral load changes, and assess safety by tracking adverse events and vital signs such as heart rate, oxygen saturation, respiration rate, and body temperature. The study also monitors for any emergence of resistance to zanamivir during the follow-up period to better understand treatment outcomes and safety in this young population.

Researchers are evaluating the functional outcomes of two types of shoulder replacement surgeries—anatomic total shoulder arthroplasty (TSA) and reverse total shoulder arthroplasty (RTSA)—for patients with primary glenohumeral osteoarthritis who have intact rotator cuffs and no significant glenoid retroversion. The study aims to determine if RTSA provides at least as good results as anatomic TSA and also to explore whether RTSA might lead to better clinical and radiographic outcomes with fewer complications. Participants will be randomly assigned to receive either an anatomic TSA or an RTSA through a deltopectoral surgical approach. Both procedures involve implanting a prosthesis designed to treat primary glenohumeral arthritis. The study compares these two surgical options over a follow-up period of two years. During the study, patients will be assessed using several measures including the American Shoulder and Elbow Surgeons (ASES) score, Subjective Shoulder Value (SSV), range of motion, pain on a visual analog scale, Constant score, and Short Form-12 (SF-12). Radiographic evaluations and complication rates will also be recorded over the two-year postoperative period. The total participation duration includes baseline assessment and follow-up evaluations spanning up to two years after surgery.

Shock is a serious condition that can cause multiple organs to fail and can be life-threatening. This research focuses on patients with distributive shock who have low blood pressure despite receiving common vasopressor drugs like noradrenaline and vasopressin. The study evaluates the relationship between renin levels, an enzyme involved in blood pressure regulation, and the use of synthetic angiotensin II, a drug given when standard vasopressors are not enough. Researchers aim to understand which patients might benefit most from angiotensin II treatment based on renin concentration changes. Participants who are adults with distributive shock not responding adequately to noradrenaline and vasopressin will receive an infusion of angiotensin II starting at 20 ng/kg/min, adjustable up to 40 ng/kg/min as needed. Blood samples will be taken before the infusion and six hours afterwards to measure renin levels. This observational study will track how renin changes during treatment and how it relates to clinical outcomes. During the study, researchers will monitor the number of days patients remain free from organ failure and days spent outside the intensive care unit over 30 days. They will also assess the duration of vasopressor need, the requirement for mechanical ventilation or dialysis, and trends in renin levels within the first six hours. The study participation will last up to 30 days, with close observation of patient responses to angiotensin II and their overall clinical progress.