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110 active trials for Infection

Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care

Well-child care is the primary source of preventative health care for children. These visits provide an opportunity for physicians to assess an infant's biomedical health, development, and behavior, as well as help ensure timely immunizations, reduce the use of acute care services, and assess and family functioning. Yet, disparities in the utilization of pediatric care exist by race, ethnicity and income in the U.S., even despite high rates of overall access to primary care. Incentives have been proposed as one way to increase utilization of preventative care for mothers and children. Diapering is another important form of preventative health care that can be particularly difficult for low-income parents due the cost of diapers, which is $70-80 per child per month, or approximately $960 per year, on average. And government programs, such as Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), Supplemental Nutrition Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF), either cannot be used to purchase diapers, or do not provide enough assistance to cover the cost of diapers and other basic needs. A family's inability to provide an adequate supply of diapers for their child is called diaper need. Nationwide, one in three families with young children report experiencing diaper need, which was found to be significantly associated with maternal stress and depression, which in turn, can have a detrimental impact on a family's health and economic success. The primary goal of this study is to conduct a randomized controlled trial of a diaper provision intervention designed to increase utilization of, and adherence to, well-child visits and reduce diaper need among low-resourced families in New Haven, CT.

Start: April 2019

Why in Hospital After VATS Lobectomy

The study aims to identify specific or potential reasons that prolong the length of hospital stay after video-assisted thoracoscopic surgery lobectomy. The hypothesis is that patients who are still in hospital after video-assisted thoracoscopic surgery lobectomy are associated with prolonged air leak, infection, pneumonia, atrial fibrillation or other complications or social factors.

Start: April 2020

Single Use ERCP -SURE Study

We do ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as bile duct stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post ERCP is around one in 200. There are some group of patients where this risk is significantly increased. In this high risk group, the risk increases from 1 in 75 to in some diseases 1 in 15 (Described in PIS). There are some reports that some of the infection may be contributed by contamination of bacteria in the scope. This happens even after diligently sterilizing the scope. A multi-centre study reported that the risk of contamination is as high as 39% but what we do not know is how many resulted in bacterial infection. We do not know what percentage of infection is secondary to the above. The new single use duodenoscope has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked and a single centre study reported that the above performance of the above scope was comparable to the standard reusable scope. We want to assess the scope simultaneously in multiple different hospitals. In addition, we also want to assess the cost consequence to the NHS for using the above scope. Hence we want to assess the performance of the scope in the high risk groups for infection.

Start: January 2021

Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients

Observational study Primary Objective: To study whether ECMO alters the PK of anti-infectives including voriconazole, posaconazole and caspofungin in critically ill patients on ECMO Secondary Objectives: Develop Population PK models of anti-infectives, including voriconazole, posaconazole and caspofungin in critically ill patients on ECMO Develop Physiological-Based PK (PBPK) model of anti-infectives, including: voriconazole, posaconazole and caspofungin in critically ill patients on ECMO Study population: Critically ill patients on ECMO Methodology: Observational study to determine whether ECMO alters the PK of anti-infectives, by developing PK models This is a non-interventional descriptive study in that the anti-infective drug selection and dosing will be at the discretion of the clinician, based on the clinical context and unit guidelines. Doses will be reconstituted and administered as per local hospital protocols in line with patient's routine care. Patients will be asked to provide additional blood samples over the course of the anti-infective dosing schedule, these samples will be taken from existing arterial lines to help guide treatment in future patients on ECMO receiving these anti-infectives.

Start: September 2018

Validation of Drug Assays in Various Biological Matrices

This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.

Start: October 2014

Host RNA Signature in Children With Cancer and Infection

The aim is to investigate if RNA expression signature can discriminate bacterial from viral infection or non-infectious inflammation in children with cancer. Earlier studies in immunocompetent children have shown promising results, but studies in immunocompromised children are lacking. We aim to include 300 febrile episodes in children with cancer. The samples will be analysed by RNA sequencing. If succesfull, this method can help prevent unnecessary antibiotic treatment, reduce hospital admissions, side effects and antimicrobial resistance and improve quality of life for children during cancer treatment.

Start: June 2019

Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery

PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery. Patients will be recruited from low and middle income countries and randomly assigned to a trial treatment arms: a) pre-operative chlorhexidine mouthwash and 80-100% FiO2; b) no pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.

Start: November 2020

C-reactive Protein Information and Blood Cultures for Emergency Department Patients With Sepsis

Patients with sepsis (2 or more systemic inflammatory response syndrome criteria and suspected infection) assessed in the emergency department have blood cultures obtained to identify potential blood stream infections (BSI). Blood cultures are expensive, sometimes inaccurate, and only positive about 10% of the time in the emergency department. This study evaluates the effect of physician knowledge of C-reactive protein (CRP) levels on ordering rates of blood cultures in emergency department patients with sepsis. All patients with sepsis will have CRP levels measured using a point-of-care device, prior to blood tests being ordered. Half of participants will have their CRP level available to the emergency physician and half will not. Blood culture ordering rate and safety outcomes will be compared between these two groups.

Start: January 2017

The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures

The purpose of the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems

Start: October 2020

A Pharmacokinetics Study of Daptomycin in Critically Ill Patients and Effects of Daptomycin on Kidney

Daptomycin ?is the ?rst approved member of a new class of antimicrobials, the cyclic lipopeptides, and presents selective action against gram-positive bacteria, including methicillin- and vancomycin-resistant strains?disrupting the transfer of amino acids in the cell membrane, thus hindering the biosynthesis of bacterial cell cell wall peptide polysaccharide, changing the properties of cytoplasm membrane, can destroy bacterial cell membrane function in many ways, and quickly kill gram-positive bacteria. Because of its unique chemical structure and sterilization mechanism, bacteria rarely develop resistance to daptomycin. Daptomycin can be reversibility combined with human plasma protein (mainly serum albumin) and metabolized mainly through the kidneys. There is still a lot of controversy about the application of daptomycin in patients with severe illness. Although studies suggest that daptomycin has less damage to kidney function than vancomycin, the effect of daptomycin on kidney function in severely ill patients is not yet clear, and more clinical studies are needed to explore their relationship. In addition, it is not clear whether the physiological pathology of specific populations such as sepsis/infectious shock, acute kidney injury, (AKI), hypoproteinemia, and renal replacement treatment affects the pharmacokinetics/pharmacodynamics of Daptomycin. By exploring the application of daptomycin in patients with severe illness, this study explores the effects of special pathological physiological states such as sepsis/infectious shock and hypoproteinemia on daptomycin PK/PD, as well as the effects of different hemoglobin concentrations of daptomycin on the outcome of kidney function.

Start: December 2020

Mitochondrial DNA as a Biomarker of Sepsis Severity

Mitochondria are organelles (a specialized subunit of a cell) responsible for providing cells with energy. For reasons not yet understood, mitochondria will release their DNA into blood in response to cellular injury or cell death. With a simple blood draw, investigators can measure the amount of mitochondrial DNA in a patient's blood. The investigators' hypothesis, is that mitochondrial DNA can be used as a surrogate marker of cellular injury to predict patient outcomes. The investigators intend to test their hypothesis by measuring mitochondrial DNA in adult patients presenting to the Emergency Department with sepsis (a life-threatening condition due to an infection) and observing their hospital course.

Start: February 2017

Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis

The vaginal mucosa is inhabited by both fungal and bacterial microorganisms which normally co-exist with the host in a tightly regulated and commensal manner.

Start: September 2020

Paediatric Rapid Sepsis Trigger (PRST) Tool

Sepsis is the leading cause of death and disability in children, every hour of delay in treatment is associated with greater organ damage and ultimately death. The challenges, especially in poor countries, are the delays in diagnosis and the inability to identify children in urgent need of treatment.To circumvent these challenges, we propose the development and clinical evaluation of a trigger tool that will reduce the time to diagnosis and prompt the timely initiation of life-saving treatment. The key innovations are 1) a data-driven approach to rapid diagnosis of sepsis severity and 2) a low- cost digital tagging system to track the time to treatment. The tool will require minimal cost, clinical expertise and training or time to use. The tool will identify high risk children and reduce time to treatment. The digital platform (mobile device and dashboard) will create a low-cost, highly scalable solution for children with sepsis.

Start: April 2020

Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

This is a cluster-randomized trial of nursing homes to assess whether decolonization with routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce hospitalizations associated with infections, antibiotic utilization, and multi-drug resistant organism (MDRO) prevalence. The comparator arm will be routine bathing care.

Start: April 2017

Vitamin D Intervention in Infants - 6 Years Follow-up (VIDI2)

Exposure to vitamin D intervention in early life may have permanent effects on physiology and metabolism. Bone growth and mineralization, development of immunity, body composition and brain structure and functioning may be affected. The importance of a long-term surveillance includes follow-up of both beneficial but also harmful effects of vitamin D. Vitamin D intervention in infants (VIDI) study was conducted in 2013-2016. VIDI study was a large randomized trial that aimed to evaluate effects of two vitamin D supplemental doses of daily 10 ug and 30 ug from the age 2 weeks until 2 years on bone strength, infections, immunity, allergy, atopy and asthma, neurologic and cognitive development, and genetic regulation of mineral homeostasis. Current study is a 6 Years Follow-up (VIDI2) study of the original VIDI trial. Our focuses of interest in the follow-up are: bone strength, growth pattern, body composition, and morbidity due to infections and allergic diseases, and the development of immunity. Further, in addition to more classical associates of vitamin D, our aim is to continue to follow-up children's neurocognitive development and mental health. We will also focus on the effect of vitamin D supplementation on occurrence of molar-incisor hypomineralization, dental caries, and oral immunity.

Start: November 2019

Improving Dosing of Vancomycin in Young Infants With Infections

Current dosing regimens for vancomycin result in many young infants not reaching the target level of vancomycin in the blood at steady state (when the blood is in equilibrium at 24-48 hours).The purpose of this study is to assess an improved method of calculating the dose of vancomycin ('model-based dosing') in young infants with infections in order for them to achieve the target vancomycin level at steady state. A dosing calculator (which will be available through a web application) will be used for the dose calculation.

Start: August 2019

Multicentre Pilot Study of Midline Catheter's Tip at Different Position

Observe and compare the incidence of complications when midline catheter's tip at 3 different location . such as thrombosis, infection, occulsion, phlebitis, and damage to the vascular intima, and catheter's indwelling time.

Start: August 2020

Optimizing Responsiveness to Feedback About Antibiotic Prescribing: 2x2x2x2 Factorial Trial

Antibiotic overuse is common and antibiotic prescribing contributes to rising rates of antimicrobial resistance. Primary care physicians prescribe the majority of all antibiotics and there is large inter-physician variability in prescribing that cannot be explained by differences in patient populations. Peer comparison audit and feedback (A&F) can act as an effective behavioural intervention to reduce unnecessary antibiotic use. The range of effects seen in prior A&F trials could be attributed, at least in part, to differences in the way the feedback interventions were designed. In fall 2018, the investigators conducted an audit and feedback trial of mailed letters to 3500 family physicians in Ontario who prescribe the highest volume of antibiotics [NCT03776383]. While effective, family physicians questioned the credibility of the report in terms of its ability to fairly account for their practice size and population. The optimal approach to providing feedback regarding antibiotic prescribing remains unknown. In this protocol, the investigators compare 4 intervention design-elements in a multifactorial design.

Start: November 2021

Recognition of Serious Infections in the Elderly

The aim of this diagnostic accuracy study is to develop a clinical prediction rule based on signs, symptoms, patient characteristics and blood tests, to be used in ambulatory care to help physicians safely rule out a serious infection in an older patient. It will be performed in general practices across Flanders (Belgium).

Start: October 2020

Barrier-Protect Study

This study will evaluate the effect of an iodine impregnated barrier dressing on device pocket swab culture positivity. Minimizing contamination during the implant procedure can be one of the potential improvements to prevent CIED infections. Patients requiring a lead change, battery change or device upgrade will be eligible. This is a randomized, blinded study where participants will be randomized to having the barrier dressing applied before any incision is made (experimental group) or applying the dressing just prior to collecting the culture swab (control group). Patients and the staff taking the culture swab at the end of the procedure are blinded as to which group the participant is randomized to.

Start: October 2020