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Transplantation Infection clinical trials

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NCT ID: NCT03699254 Completed - Clinical trials for Cytomegalovirus Infections

Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients.

CYTOCOR
Start date: April 5, 2019
Phase: Phase 3
Study type: Interventional

To assess the efficacy of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease.

NCT ID: NCT02777632 Completed - Clinical trials for Transplantation Infection

Resistant Bacterial Infections in the Early Post LDLT Period

Start date: January 2014
Phase: N/A
Study type: Observational

The purpose of this work was to study the incidence, types, risk factors and causative organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation. Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy

NCT ID: NCT02463214 Completed - Clinical trials for Transplantation Infection

Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients

Start date: September 2015
Phase: N/A
Study type: Interventional

This study involves sampling bone marrow transplant patients, hospital workers and the patient room for microbes using swabs and other techniques. We send these samples to the laboratory, where they will use state-of-the art technology to identify and relate the microbes to each other. This study also involves putting copper, nickel, or titanium into some hospital rooms, and seeing whether these metals influences the growth of microbes. Some equipment in the hospital room, such as faucets and soap dispensers will be replaced by sensor-based (e.g. touchless) controls.

NCT ID: NCT02329808 Completed - Kidney Diseases Clinical Trials

Clinical Validation of a Dried Blood Spot Method for Analysis of Immunosuppressives and Antifungals in Pediatrics

PROTECT
Start date: June 2015
Phase:
Study type: Observational

This is a clincial validation study of a dried blood spot (DBS) method for the analysis of immunosuppressive and antifungal agents currently subject of therapeutic drug monitoring (TDM) in a pediatric population. The primary goal is to clinically validate a finger prick DBS method compared to conventional venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the pediatric population. Secondairy goals include feasibility of the finger prick DBS method in the target population, to design an inventory of costs that will be incurred in future health-economic analyses and to construct a population PK model based on the available data collected for the primariy goal.

NCT ID: NCT02328963 Completed - Clinical trials for Cytomegalovirus Infection

Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A

EVERCMV
Start date: May 2, 2014
Phase: Phase 4
Study type: Interventional

Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after transplantation. It is associated with an increased incidence of acute rejection and lower graft and patient survivals. The goal of this study is to demonstrate that an immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can prevent acute rejection episodes as efficiently as standard regimen but also efficiently reduce the incidence of CMV infection at 6 months post-transplantation.

NCT ID: NCT02294032 Completed - Clinical trials for Transplantation Infection

The Role of B Cells in Kidney Allograft Dysfunction

Start date: August 28, 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune response after kidney transplantation. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.

NCT ID: NCT02084446 Completed - Clinical trials for Cytomegalovirus Infections

Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant

Start date: December 2012
Phase: Phase 4
Study type: Interventional

This is a 12-month single center, randomized, open-label, single center study designed to compare the safety and efficacy of everolimus and very low dose tacrolimus versus enteric-coated sodium mycophenolate and low tacrolimus exposure in de novo kidney transplant recipients. The purpose of this study is to compare safety and efficacy of two immunosuppressive regimens based on low tacrolimus exposure combined to everolimus or to enteric-coated mycophenolate sodium (EC-MPS) in de novo kidney transplant recipients.

NCT ID: NCT01972035 Completed - Clinical trials for Cytomegalovirus Infections

ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

Start date: August 1, 2014
Phase: Phase 2
Study type: Interventional

Our study will compare all kidney transplant recipients receiving valganciclovir vs. valacyclovir for one year following kidney transplant and compare: 1. the incidence, magnitude and duration of CMV and EBV viremia in the first year after transplant. 2. the side effects of the anti-viral drugs requiring dose reduction or cessation In addition, we will test renal tissue obtained from any biopsies post-transplant (surveillance or clinically indicated biopsies) by both polymerase chain reaction (PCR) and fluorescence in situ hybridization to assess for latent CMV and/or EBV.

NCT ID: NCT01808456 Completed - Influenza, Human Clinical Trials

Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.

Start date: October 2013
Phase: Phase 4
Study type: Interventional

Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccination is recommended in these high-risk patients, safety and immunogenicity of commercially available different strengths of influenza vaccine have not been established. The primary study objective is to determine the safety and immunogenicity of Fluzone and Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are commercially available for use in the general population. Fluzone is approved for use in 6 months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and older. This is an exploratory, open-label, parallel group, observer blinded, prospective study. All recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be eligible for enrollment. Enrolled patients will be followed for three months (a total of 4 visits) following enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and 12.

NCT ID: NCT01767350 Completed - Clinical trials for Transplantation Infection

Determinants of Immunosuppressive Dose Requirements in Children After Solid Organ Transplantation

Start date: February 2013
Phase: N/A
Study type: Observational

The long-term success of solid organ transplantation is largely dependent on the efficacy of immunosuppressive medication. Unfortunately, for the most important agents the correct drug levels are difficult to attain, with potential severe consequences of drug under- or overexposure. In addition there is a large variation in dose requirements within and between different subjects. Clinical studies have demonstrated that a better control of drug exposure can improve outcome. A large set of patient characteristics appear important in determining dose requirements in adults, in particular genetic variation in genes involved in drug metabolism. In children relative dose requirements are increased compared to adults, but is not known why and the role of pharmacogenetic variation has not been described. Our study aims to describe relative dose requirements in children after solid organ transplantation with the help of clinical and laboratory data obtained during regular hospital visits (retrospective). In addition we will assess their genotype for genes involved in the metabolism of immunosuppressives.