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NCT ID: NCT06468163 Not yet recruiting - Clinical trials for Local Antibiotic Injection Catheter Acute Periprosthetic Infections Knee DAIR Randomized Controlled Trial

Efficacy of Local Antibiotic Injection Via a Catheter for Treating Acute Periprosthetic Infections After Knee DAIR Surgery

YES
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Prosthetic Joint Infection (PJI) is a severe complication following joint replacement surgery, imposing significant economic and health burdens on patients. For acute PJI, the DAIR (Debridement, Antibiotics, and Implant Retention) procedure is a necessary and effective treatment method, as it effectively clears the infection while preserving the prosthesis, thereby avoiding more complex surgical interventions. However, the practice of using drainage tubes postoperatively is controversial. Some studies suggest that drainage tubes may increase the risk of infection, while other literature indicates no statistically significant difference in infection risk associated with their use.In this context, Professor Li Cao's team at Xinjiang Medical University has improved the traditional DAIR procedure by incorporating long-term local antibiotic injections post-surgery, achieving positive results. Despite this, the specific method of antibiotic injection, particularly whether to use a drug infusion tube, remains under debate. The use of an infusion tube can reduce patient discomfort, shorten the local disinfection process, and theoretically decrease the time the incision is exposed to the external environment, potentially lowering the infection risk. However, the validity of these theoretical assumptions needs further confirmation through high-level scientific research. This study aims to evaluate whether there are differences in joint function recovery, changes in blood infection markers, and the incidence of postoperative complications between using and not using an infusion tube for local antibiotic injection after knee DAIR surgery. To assess the value of the infusion tube in local antibiotic injection post-knee DAIR surgery, a randomized controlled trial (RCT) will be conducted. Eligible patients will be randomly assigned to the infusion tube group (experimental group) or the non-infusion tube group (control group). The study will prospectively collect basic information, joint function scores, blood infection markers, and postoperative complication data from both groups, including patient age, gender, educational background, and postoperative blood test results. Ultimately, the RCT aims to demonstrate the therapeutic efficacy of the infusion tube method.

NCT ID: NCT06467734 Not yet recruiting - Clinical trials for Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection

Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection

Yes
Start date: August 1, 2024
Phase:
Study type: Observational

Prosthetic Joint Infection (PJI) is one of the severe complications following arthroplasty. With the global aging population, the number of patients undergoing primary joint replacement surgeries is increasing, leading to a rise in PJI cases. Although the incidence of PJI is generally low, the impact on patients can be catastrophic. Once an infection occurs, it is further complicated by the rising global antibiotic resistance, imposing a significant economic burden on patients. Therefore, improving the diagnostic rate of PJI is crucial. Currently, various infection markers are used in the diagnosis of PJI. However, there is still a lack of highly sensitive and specific markers to effectively diagnose PJI, necessitating the exploration of new infection markers. This study aims to investigate novel infection markers for the diagnosis of PJI, providing evidence for its diagnosis and subsequent treatment. In this research, we will prospectively collect data from patients undergoing primary joint replacement and those developing PJI from June 2024 to December 2026. These patients will be categorized into non-infection and infection groups. By collecting and analyzing general patient data, surgery-related information, and infection-related indicators from preoperative joint fluid and blood samples, we aim to further evaluate the predictive value of these infection markers for PJI.

NCT ID: NCT06465901 Not yet recruiting - Clinical trials for Surgical Site Infection

A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI

MARLIN
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

MARLIN is a stratified, multi-arm, multi-stage factorial randomised platform trial aiming to reduce the incidence of post-operative surgical site infection (SSI).

NCT ID: NCT06464770 Not yet recruiting - Clinical trials for Periprosthetic Joint Infection

Optimizing Infection Prophylaxis Prior to Shoulder Surgery

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. The main question it aims to answer is: Does changing the pressure applied during the ChloraPrep application impact the amount of C. acnes bacteria on the skin after one hour? Researchers will compare ChloraPrep applied at a pressure similar to a gentle wipe to ChloraPrep applied at a pressure similar to a massage to see if wash the amount of C. acnes on the skin after one hour is different. Participants will have one shoulder washed with ChloraPrep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with ChloraPrep using pressure meant to impact the subdermal layer, similar to a massage. Participants will have swabs taken of their skin before the ChloraPrep application and again one hour after application to look for the amount of C. acnes on the skin.

NCT ID: NCT06463704 Not yet recruiting - Healthy Volunteers Clinical Trials

General Pre-Trial Screening Protocol for Infectious Diseases Research

Start date: June 2024
Phase:
Study type: Observational [Patient Registry]

The purpose of this general screening protocol is to facilitate recruitment into studies conducted at the Center for Virology and Vaccine Research (CVVR) or Division of Infectious Diseases at Beth Israel Deaconess Medical Center. This general screening protocol will help to determine the eligibility of potential volunteers for any vaccine or therapeutic trials open for recruitment or soon to be opened.

NCT ID: NCT06463314 Not yet recruiting - HIV Infections Clinical Trials

Multiplex Near Patient Non-HCP Study

Start date: July 2024
Phase: N/A
Study type: Interventional

To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. bioLytical Laboratories Inc. (Richmond, BC, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood sample that was licensed by Health Canada in March 2023 for use by trained health care professionals. The goal of this study is to provide evidence that untrained, non-registered health care providers (ie. peer testers) can perform the test without any increased risk of obtaining erroneous results. This test requires no instrumentation and can be used by non-registered health care professionals including peer testers ("Operators") in multiple near patient settings such as community health centres and point of care testing locations.

NCT ID: NCT06462235 Not yet recruiting - Clinical trials for Gram-negative Bacterial Infection

A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)

CHERISH
Start date: September 16, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria. The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections. The study will include newborns and infants up to 9 months of age who are admitted in the hospital. The study is conducted in 2 parts: Part A and Part B. In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount. In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.

NCT ID: NCT06458504 Not yet recruiting - SARS-CoV-2 Clinical Trials

Viral Infection of HSPC Impacts Hematopoiesis

MEGAHOST
Start date: June 2024
Phase:
Study type: Observational

We propose to demonstrate that HIV-1 and SARS-CoV-2 are capable of targeting long-lived HSPC with self-renewal capacities. These progenitors, thus transformed into host cells, can give rise to a durable source of infected cells with an impact on hematopoiesis.

NCT ID: NCT06456424 Not yet recruiting - Clinical trials for Staphylococcus Aureus Infection

Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection

PHAGE-2024-01
Start date: June 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage cocktail to treat and prevent the recurrence of a methicillin-susceptible Staphylococcus aureus prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to his quality of life. The treatment involves a one time, intra-operative injection of bacteriophages into the joint and 14 days of intravenous phage therapy. The goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.

NCT ID: NCT06450990 Not yet recruiting - Bacterial Vaginosis Clinical Trials

Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection

ELINA
Start date: July 8, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product (BGY-1601-VT) intended as a first line of treatment in cases of acute vaginal infection without upfront microbiological confirmed diagnosis