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110 active trials for Infection

Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.

The effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first knee. Therefore, this prospective study compared minor and major local complications for 90 days postoperatively between the first and second during knee single-team simultaneous bilateral total knee arthroplasty.

Start: May 2020

Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

The primary aim of the study is to compare two methods for a relationship with total knee infection: regular changing of dressings and not changing dressings.

Start: May 2020

Just-in-time Elastomeric Training and Fit Testing (JET FIT)

This is a clinical trial to evaluate feasibility of a just in time elastomeric half mask respirator (EHMR) fit test and competency training for healthcare personnel (HCP) during a simulated public health emergency.

Start: April 2019

Detection and Inflammatory Characterization of Deep Infection After Surgery for Locally Advanced Rectal Cancer With Microdialysis Catheters

The intention of the study is to explore metabolic and inflammatory parameters in the pelvis after abdominoperineal resection for locally advanced rectal cancer in patients that have received radiation therapy before surgery.

Start: October 2016

The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery

The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infections. Patients will be randomized to the chlorhexidine or no additional intervention groups. Patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no additional intervention. Those randomized into the chlorhexidine gluconate (CHG) home-application group will be asked to shower the night before surgery, and to use a standardized pre-packaged CHG wipe (that the patients would receive at their pre-surgical consultation) on their surgical site after thoroughly drying those areas. The patients will be asked to use a second wipe in each area the morning of surgery. The surgical sites will be analyzed in two groups: anterior cervical and posterior spine. Each of these two groups will be randomized separately. All patients will undergo a standardized preoperative cleansing regimen. Once positioned, they will be cleansed with an alcohol solution. Then, the surgical site (either the anterior portion of the neck or the posterior area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with chlorhexidine solution. Perioperative antibiotics will be given per attending surgeon preference. Cutaneous samples will be taken from the surgical site of each patient at each time point.

Start: February 2016

Human Microbiota and Liver Transplant

The microbiota represents the collections of microbial communities that colonize a host. In health, the microbiota protects against pathogens and maturation of the immune system. In return, the immune system determines the composition of the microbiota. Altered microbial composition (dysbiosis) has been correlated with a number of diseases in humans. The real role of the microbiota in transplant recipients is still unknown even though we suspect that it may be affected directly or indirectly by immunosuppressive drugs and antimicrobial prophylaxis taken by transplant patients, as well as by inflammatory process secondary to ischemia/reperfusion injury. A number of studies have investigated the impact of liver transplantation on the intestinal microbiota. In a recent analysis of stool flora (Microb Ecol 2013; 65: 781-791) in 12 liver transplant recipients, changes in the microbiota were correlated to post-transplant infections. The authors suggested that the shift to pathogenic strains of bacteria due to the use of prophylactic antibiotics may be contributing to post-transplant complications. In a larger study, Wu et al (Hepatobiliary Pancreat Dis Int 2012; 11: 40-50) demonstrated marked changes in the gut microbiota post-transplantation with an increase in Enterobacteriaceae and Enterococcus, and reduction in Eubacteria, Bifidobacterium and Lactobacillus species. These changes, however, resolved over time such that by 6 months, at times when bacterial prophylaxis ends and immunosuppression is reduced. A better characterization of the impact of post-transplant therapy on the human microbiota has the potential to improve our understanding of the infection process and translate into development of new therapeutic strategies. The main goal of this study is to characterize intestinal microbiota and confirm the same bacterial DNA in peripheral blood and portal lymph nodes in patients affected with end-stage chronic liver disease, and to analyze its evolution from the moment of inclusion in waiting list throughout the first year after liver transplantation. For each patient, a healthy CONTROL with a similar age (± 10 years) will be selected from the same family setting, in whom just one sample will be obtained during the enrollment phase. The second goal is to analyze the potential associations between microbiota flora and transplant outcomes during the same period.

Start: January 2016

Allergy Antibiotics And Microbial Resistance

ALBAMA study is designed to find out if the Penicillin allergy assessment pathway (PAAP) intervention is clinically effective in improving patient health outcomes.

Start: July 2019

Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

Obesity alters the movement through the body of several antibiotics, including vancomycin. Based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. However, hospitals have different approaches to managing vancomycin in this patient population. The most common example is not exceeding a dose of 2,000mg of vancomycin at one time in these patients. However, some institutions including the Charleston Area Medical Center do not have a set maximum one time dose. To date, a study has not been done comparing two different dosing regimens in obese patients to determine if having a maximum dose cap is beneficial. This research study is attempting to add to the limited existing body of literature regarding vancomycin dosing in obese patients. The investigators hypothesize that optimizing the initial or loading vancomycin dose that obese patients receive will decrease the time to target concentrations. For this study, obese adult patients will be randomized to receive either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine differences in the time needed to achieve target vancomycin concentrations and the occurrence of adverse events.

Start: August 2016

Efficacy of Gastrostomy Tube Coated With Povidone-iodine for Reducing Peristomal Infection Rate After PEG Insertion

Percutaneous endoscopic gastrostomy (PEG) was created to replace surgical gastrostomy in patients who are needed long-term tube feeding. PEG has less severe complication rate or mortality rate compared with traditional surgical gastrostomy. However, there are still some mild complications which cannot be completely prevented and peristomal infection is the most common one. Povidone-iodine (PVP-I) exhibits broad range of microbicidal activity via increasing the solubility of iodine. In our study, the gastrostomy feeding tube will be coated with a layer of Betadine before PEG technique. Investigators expect gastrostomy feeding tube coated with Betadine will reduce the oropharyngeal, esophageal and gastric bacteria colonization rate, followed by reducing peristomal infection rate.

Start: April 2014

Decreasing Infection In Arthroscopic Shoulder Surgery

Despite the use of a standard preoperative skin disinfectant prior to shoulder surgery propionibacterium acne remains a leading cause of post-operative infections. The purpose of this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to chlorhexidine-impregnated skin preparation in attempting to lower the colonization propionibacterium acne prior to surgery. This study will take cultures from patients who are randomly assigned into groups that receive and do not receive benzoyl peroxide as additional skin prep prior to elective shoulder surgery and compare quantified culture results.

Start: September 2015

Non-Invasive Shock: Differentiating Shock in the Emergency Department

The goal of this study is to compare the characteristics of echocardiography and different monitoring devices in shock patients, the relationship of device parameters to biomarkers associated with shock, and determine if these any of these add clinical utility when predicting the cause of shock. We will perform a prospective, observational study of patients found to have shock physiology in the ED and follow them to determine the final shock category and ultimate outcomes.

Start: November 2012

Biomarkers in Infection

The purpose of this investigation is to evaluate how early biomarkers of infection and inflammation perform in identifying patients at risk for poor outcome in sepsis and septic shock.

Start: April 2006

Antibiotic Loaded Calcium Sulfate RCT

This is a multi-centered, prospective, randomized controlled trial comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions.

Start: January 2020

Next Generation Pathogen Sequencing for Prediction of Infection in Rheumatic Disease

The majority of patients diagnosed with rheumatic disease, such as systemic lupus erythematosus, inflammatory myositis, and vasculitis, will experience fever or infection during their course of therapy. The most common microbiologically documented infection is bacterial, virus, and fungal, which can be associated with the severity and mortality of disease. Current methods of diagnosis require a significant load of pathogen making early detection difficult. Delayed diagnosis and delayed optimal therapy of infection are associated with increased morbidity and mortality. This study seeks to identify whether next generation sequencing (NGS) of pathogens can identify patients with infection treated with corticosteroid and immunosuppressive agents. This would enable preemptive targeted therapy to replace prophylaxis treatment which often leads to some adverse events and antibiotic resistance.

Start: January 2020

Growth and Metabolism in Infants Fed Protein-reduced, Alpha-lactalbumin Enriched Formula

Formula composition is developed to resemble breast milk as close as possible, but there are still considerable differences between formula and breast milk composition, probably resulting in higher risk of overweight in childhood and higher incidence of infections in formula-fed infants. Protein levels are still higher and constituents such as alpha-lactalbumin lower in formula than in breast milk. By adding more alpha-lactalbumin to formula, rich in tryptophan, the resulting amino acid composition will allow further reduction of protein in formula. The investigators intend to include 320 infants, where 80 will be exclusively breastfed and the remainder assigned in a double blind, controlled, randomized manner to one of three formula groups; two experimental, protein reduced formula with two different levels of alpha-lactalbumin and one group given standard infant formula. The intervention period is from 4-8 weeks until 6 months of age. The infants will be followed by growth parameters, blood-, urine- and fecal biomarkers and health parameters until 5 years of age. The experimental formula will possibly result in growth, metabolism and gut microbiota as well as health parameters more similar to those of breastfed infants

Start: November 2014

Fever During Labour

Pilot study to assess fever during labour.

Start: November 2019

The Incidence of Infection in Treatment of Low-dose IL-2 of SLE Patients

IL-2 is a pleiotropic cytokine which can regulate or stimulate the differentiation and function of CD4+, CD8+ and NK cells. An opened-labelled trial and a retrospective study have indicated the incidence of infection is lower in the treatment of low-dose IL-2 combined with corticosteroid and immunosuppressor. We are going to conduct a multi-center prospective observational study to verify the above results.

Start: July 2019

Effect of Surgical Wound Infection on Health

A surgical site infection (SSI) is an infection that occurs after surgery in the part of the body

Start: October 2018

Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.

This study aims to assess the effectiveness and cost-effectiveness of rectal swab culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal prostate biopsy. Half of participants will receive routine empirical prophylaxis with oral ciprofloxacin (control group), while the other half will receive rectal culture-guided oral antibiotic prophylaxis (intervention group). In the intervention group, men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prophylaxis, comparable to the control group. In case of ciprofloxacin-resistant bacteria an alternative oral antibiotic based on the culture results will be prescribed (trimethoprim/sulfamethoxazole, fosfomycin or pivmecillinam/augmentin). The investigators hypothesise that the targeted prophylaxis group (intervention group) will have a lower rate of post-biopsy infectious complications compared to the control group.

Start: April 2018

The Effect of Oral Antibiotics on Synovial Fluid and Differential for the Diagnosis of Infection

Periprosthetic joint infection following total hip or knee arthroplasty is a rare but potentially devastating complication. Accurate diagnosis of these infections remains one of the most challenging undertakings in orthopaedics. Multiple studies have shown the high diagnostic accuracy of synovial fluid white blood cell count (WBC) and neutrophil percentage (%PMNs) in detecting PJI. This study's goal is to evaluate how antibiotics affect those two important diagnostic measures.

Start: November 2017