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NCT ID: NCT03107169 Completed - Clinical trials for Clostridium Difficile Infection

Treatment of Initial Clostridium Difficile Infection

Start date: February 1, 2015
Phase: N/A
Study type: Interventional

Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.

NCT ID: NCT03106844 Completed - Clinical trials for Inflammatory Bowel Diseases

The ICON Study: Outcomes After FMT for Patients With IBD and CDI

Start date: August 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.

NCT ID: NCT03101371 Completed - Clinical trials for Urinary Tract Infections

Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

Start date: October 10, 2017
Phase: Phase 2
Study type: Interventional

Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.

NCT ID: NCT03089970 Completed - Clinical trials for Upper Respiratory Tract Infections, Asthma, Exhaled Breath

Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients

Start date: February 1, 2017
Phase:
Study type: Observational

Respiratory virus infections cause a majority of asthma exacerbations in the fall to spring months. Current diagnostic platforms for respiratory viruses have limitations including cost, availability, and invasiveness. The use of noninvasive breath collection to analyze breath metabolites may be used to differentiate virus-infected asthmatics from other causes of acute asthma exacerbations.

NCT ID: NCT03087890 Completed - HIV-1-infection Clinical Trials

Impact of Cotrimoxazole Use in Immunocompetent HIV Patients on Carriage of Antimicrobial Resistant Bacteria

CoTrimResist
Start date: March 30, 2017
Phase: Phase 4
Study type: Interventional

Cotrimoxazole preventive therapy (CPT) is recommended for prevention of morbidity and mortality due to Pneumocystis pneumonia and other infections in HIV positive patients with low immunity. Common clinical practice is to start CPT in any patient with CD4 counts below 200/µL, and, conversely, to stop CPT when immunity has been restored by antiretroviral treatment to CD4 counts above 200/µL or when viral suppression has been documented for 3 months. However, the latest WHO guidelines widely expands the indication for CPT by advocating for settings with high prevalence of malaria and bacterial infections, that all patients with HIV start CPT regardless of CD4 counts and clinical stage. Furthermore, WHO recommends these patients to continue CPT indefinitely regardless of evidence of immune restoration (The recommendation is for settings with high prevalence of malaria and bacterial infections, not for high-income countries). There is limited scientific evidence to recommend prolonged CPT, as studies have shown it is associated with modestly reduced morbidity due to pneumonia, meningitis and malaria, but no corresponding reduction in mortality. The impact of such a large increase in antibiotic use on the emergence of antimicrobial resistance has not been thoroughly considered. Our previous studies in Tanzania showed that multidrug-resistant bacteria frequently cause bloodstream infections with resultant very high case-fatality rates. As genes encoding for multiple antibiotic resistance traits are transferred by plasmids together with resistance towards cotrimoxazole, prolonged CPT will likely favor the selection of carriage of multidrug-resistant gut bacteria. The proposed randomized clinical trial is designed to assess whether prolonged CPT in HIV-positive patients results in increased fecal carriage of multi-drug resistant gut microbes or increased nasal carriage of methicillin-resistant Staphylococcus aureus (MRSA). Secondary endpoints are morbidity (clinical events, hospitalizations) and mortality. Stool specimens, nasal swabs and clinical data will be collected from persons attending voluntary counseling and testing facilities and HIV-clinics in Dar es Salaam, Tanzania. The study results may have important impact on public health in terms of assisting development of rational recommendations for CPT use, and may help prevent emerging antibiotic resistance.

NCT ID: NCT03083756 Completed - Clinical trials for Opportunistic Infections

Validation of a Risk Score Opportunistic Infections Development in Kidney Transplant Patients

SIMPLICITY
Start date: August 2014
Phase: N/A
Study type: Observational

This study validate the usefulness of SIMPLICITY score to characterize the immune status of the kidney transplant receiver at two points along its course (the one and six months after transplantation), by determination in peripheral blood of various parameters related to cellular immunity (count subpopulations of CD3+ (cluster of differentiation 3), CD4+ (cluster of differentiation 4) and CD8+( cluster of differentiation 8)), humoral immunity (immunoglobulins count) and innate (complement).

NCT ID: NCT03081273 Completed - Clinical trials for Corynebacterium Infections

Corynebacterium Spp Bone and Joint Infection: Retrospective Study of Microbiological, Diagnostic and Therapeutic Features

Start date: June 2016
Phase: N/A
Study type: Observational

Corynebacterium spp have been considered as innocuous commensals of human skin, but are now accepted as important opportunistic pathogens responsible for various nosocomial infections, especially implicating foreign materials. In particular, they accounted for up to 10% of prosthetic joint infection (PJI), and are mostly identified in chronic forms of bone and joint infections (BJI). However, little is known about the pathophysiological pathway implicated in Corynebacterium BJI, species distribution and antimicrobial susceptibility, and the management of these difficult-to-treat clinical entities. This study aims to report a retrospective cohort of patients with Corynebacterium spp BJI, aiming to : i) describe microbiological characteristics of the implicated clinical isolates, including species identification and antimicrobial susceptibility (and especially according to previous antimicrobial exposure); ii) assess pathophysiological mechanisms associated with BJI chronicity, including biofilm formation and bone cell invasion, to better understand mechanisms of Corynebacterium spp and to evaluate their ability to distinguished colonizing and infective isolates; iii) describe the medical (nature and duration of antimicrobial therapy) and surgical management of these patients; and iv) evaluate the patient outcome according to this management strategy, and highlight risk factor for treatment failure in order to improve patient's management.

NCT ID: NCT03078335 Completed - Infection Clinical Trials

Glove-based Care in the NICU to Prevent Late Onset Sepsis

GloveCare
Start date: June 5, 2017
Phase: N/A
Study type: Interventional

Babies that get an infection after 3 days of age while in the Neonatal Intensive Care Unit is not related to their delivery but to the hospital environment. Preventing these infections results in shorter hospital stays for babies, less risk of long term health problems and less health care resources required to care for them. Hand washing alone doesn't remove all bacteria from the hands of healthcare workers, and studies have shown that infections in adults and children admitted to hospital decrease if health care providers use clean, non- sterile gloves when treating patients. The main focus of this study will be to find out if using gloves when caring for newborns in the NICU is better than washing hands alone. McMaster Children's Hospital and The Hospital for Sick Children will be the pilot sites to participate in a future larger study where some infants will be cared for using non-sterile gloves, and others will be cared for using the standard hand washing method.

NCT ID: NCT03077672 Completed - Sepsis Clinical Trials

Mitochondrial DNA as a Biomarker of Sepsis Severity

MBOSS
Start date: February 10, 2017
Phase:
Study type: Observational

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.

NCT ID: NCT03075813 Completed - Clinical trials for Surgical Site Infection

Early Recognition and Response to Increases in Surgical Site Infections Using Optimized Statistical Process Control Charts: The Early 2RIS Study

Early 2RIS
Start date: March 6, 2017
Phase: N/A
Study type: Interventional

The purpose of this quality improvement study is to measure the effectiveness of surveillance using optimized statistical process control (SPC) methods and feedback on rates of surgical site infection (SSI) compared to traditional surveillance and feedback. The primary objective is to determine if hospital clusters randomized to receive feedback from optimized SPC surveillance methods collectively have lower rates of SSI compared to hospital clusters randomized to receiving feedback from traditional surveillance methods. Secondary objectives are 1) to estimate and compare the number of signals identified using optimized SPC methods and traditional surveillance methods; 2) to estimate and compare the time and effort required to investigate signals generated using optimized SPC methods and traditional surveillance methods; and 3) to estimate the number and proportion of false-positive signals identified using optimized SPC methods and traditional surveillance methods. The Early 2RIS study will be a prospective, multicenter cluster randomized controlled trial using stepped wedge design. The active component of the quality improvement study will be performed in 29 DICON hospitals over three years, from March 2017 through February 2020. Clusters randomized to intervention will receive feedback on increasing rates of SSI identified through optimized SPC methods. This intervention is expected to decrease the subsequent rate of SSIs by closing the feedback loop on SSI outcomes. Participating study hospitals will all be members of DICON, a network of 43 community hospitals in North Carolina, South Carolina, Georgia, Florida, and Virginia that provides community hospitals access to consultative services from infection prevention experts, data analyses and benchmarking, and educational materials designed by faculty from Duke. This study is considered part of routine quality improvement measures and a part of previously established agreements between DICON and the community hospitals. Data flow and communication are outlined in detail in approved protocols determined to be exempt research by the DUHS IRB. Briefly, existing clinical data are extracted from participating hospitals' electronic medical record into discrete files according to DICON specifications. Then a de-identification process removes direct patient identifiers into a limited dataset. The majority of data collection will occur through methods already developed and utilized by study hospitals. In brief, each hospital routinely submits limited datasets to the DICON Surgical Surveillance Database, including the following variables: hospital, type of procedure, patient identifier, date of procedure, age, sex, surgeon identifier, start/stop times, ASA score, wound class, risk index, SSI (Yes/No), date of infection, type of SSI, location at diagnosis and organism. No identifiable patient or surgeon data are transmitted to the DICON Surgical Database. Data definitions and data collection methods are standardized across DICON hospitals. Following signal adjudication, additional data will be collected in a REDCap database to document actions and rationale.