Clinical Trials

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7 studies in Division of Infectious Diseases

  1. Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients

    Rochester, Minn. View Summary

    Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, Urinary tract infections(UTI) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%. There are many different types of catheters available for use. Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. Specialized catheters have been developed with the aim of reducing infection. Strategies generally involved coating the inner, outer or both surfaces of the catheter with antimicrobial materials. These materials can be antibiotic or antiseptic with the most common antiseptic material used being silver. Silver ions are bactericidal, are used safely when applied topically to humans and used in controlling infections. Previous studies comparing UTI rates in transurethral catheters have reported a significant reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that this study will show a statistically significant decrease in UTI rate among the individuals with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.

    NCT ID:

    NCT01359046

    IRB Number:

    10-007421

    Who can I contact for additional information about this study?

    Rochester: Ruchira Singh, MBBS 507-284-2511
                        


  2. An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses

    Rochester, Minn. View Summary

    An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this observational study is to describe the characteristics and outcomes over a 60-day follow-up period of participants with influenza virus infection (including influenza A subtypes such as H3N2 and 2009 H1N1, or influenza B), or a targeted non-influenza respiratory virus, who are hospitalized with severe illness and/or complications in geographically diverse locations. Specific objectives related to influenza virus infection are to estimate the percentage of participants who go on to develop severe disease or complications that require hospitalization; to obtain information on risk factors for disease severity; and to establish a central repository of specimens for use in virus characterization, including subtyping, antigenic and genetic analyses, identification of signature mutations associated with antiviral drug resistance, mutational evolution, and additional reassortment. Specific objectives related to novel non-influenza respiratory viruses of potential major public health importance are to characterize initial cases and their outcomes in order to develop more specific protocols that could inform the prevention and treatment of these new infections. The information used from this study on participants with influenza and novel respiratory virus infections will be rapidly analyzed and shared broadly in order to guide policymakers and to design future studies. Approximately 500 patients with influenza will be enrolled each year at an estimated 75 sites which are in geographically diverse locations across several continents. Study Plan: - Participants who meet the eligibility criteria will be enrolled at participating clinical sites. - Patients with a diagnosis of influenza (confirmed or suspected), who are hospitalized with complications or severe disease, will be enrolled. - At enrollment, consent is signed and information (demographics, medical history (including prior influenza and pneumococcal vaccination), medications (including antivirals) and treatments prescribed) will be recorded. A blood sample for serum and plasma will be obtained at enrollment, as well as an upper respiratory tract sample and lower respiratory tract sample, if appropriate. The respiratory specimens will be sent for central RT-PCR testing for influenza. - For participants who are still hospitalized, and not intubated, 5 to 7 days after enrollment an additional upper respiratory sample is obtained. - Status will be re-assessed at approximately 28 days and 60 days after enrollment and another blood sample for serum and plasma will obtained at both time points. - For participants who are mechanically ventilated additional upper and lower respiratory tract specimens will be obtained at specific timepoints. In February 2012, the FLU 004 Genomics protocol v 1.0 was released to the field. In August 2013, v 2.0 of the protocol was released as INSIGHT Genomics. The protocol was expanded beyond the FLU 002 and FLU 003 studies to include all qualifying INSIGHT studies (list of qualifying studies is posted on the INSIGHT website, www.insight-trials.org). The purpose of this substudy is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other genetic variants that may be associated with an increased risk of severe influenza. Participating FLU 003 Plus sites are given the option to also participate in INSIGHT Genomics which requires a separate protocol registration. Participants, once consented to FLU 003 Plus, will be offered the option to also consent to INSIGHT Genomics which includes a single whole blood sample collection. Participation in FLU 003 Plus will not be compromised if a participant opts not to participate in INSIGHT Genomics.

    NCT ID:

    NCT01056185

    Who can I contact for additional information about this study?

    Rochester: Zelalem Temesgen, MD 507-255-7938
                        


  3. HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.

    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    HCV-TARGET is a longitudinal, observational study that will create a carefully maintained research registry of HCV patients treated with antiviral therapies designed to rapidly inform strategies for better management of populations underrepresented in clinical trials, identify and remediate educational gaps relative to treatment guidelines and adverse event management in order to optimize rates of sustained virological response (SVR), and serve as the core resource for important collaborative translational studies utilizing biospecimens and clinical data from diverse patient populations. HCV-TARGET is a cooperative academic consortium of principal investigators from Clinical and Translational Award (CTSA)-funded academic institutions and community-based sites affiliated with the academic sites in geographic proximity. The Clinical Coordinating Center (CCC) resides at the University of Florida and the Data Coordinating Center (DCC) resides at the University of North Carolina at Chapel Hill. The HCV-TARGET registry will characterize the population of chronic hepatitis C (HCV) patients who are being treated with antiviral therapies at academic and community sites. Patient characteristics such as age, race, ethnicity, comorbidity, and disease and treatment status will be examined. HCV-TARGET will also: 1. Provide baseline and treatment response data that will be used to pre-identify candidates for enrollment in future clinical trials. HCV-TARGET will also develop a well-characterized cohort of protease inhibitor treatment failures to be considered for future trials. 2. Establish and maintain data, a specimen bank and other resources for ancillary studies of the pathogenesis, diagnosis, natural history and treatment of HCV infection. This study will investigate various aspects of treatment response to regimens containing direct-acting antiviral agents for the treatment of chronic hepatitis C, including the following: - Patients underrepresented in clinical trials of approved antiviral therapies(including African-Americans, patients with cirrhosis, and patients that are considered null responders to treatment.) - Treatment persistence - Virological breakthrough - Impact of viral load measurement on treatment efficacy - Adverse Event Management and Surveillance. The secondary aims for this study will investigate the following: - Sustained virological response (SVR) rates and safety in special populations. - Surveillance of drug-drug interactions. - Treatment and management adherence. - Pretreatment Education in HCV patient population. - Use of specialty pharmacy for hepatitis C therapy.

    NCT ID:

    NCT01474811

    IRB Number:

    12-001669

    Who can I contact for additional information about this study?

    Rochester: Melinda Thomas 507-293-4773
                        
    Scottsdale: Vy Nguyen 480-342-1328
                        

  4. HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

    Rochester, Minn. View Summary

    HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Aim 1. Therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B. This study will also examine if antiviral therapy has a durable effect in host immune phenotype and define the immunological effect of interferon-alpha (IFNα) therapy in chronic HBV participants. Aim 2. Antiviral immune effector and regulatory responses before, during and/or after therapy can predict long term therapeutic response.

    NCT ID:

    NCT01796457

    IRB Number:

    11-000706

    Who can I contact for additional information about this study?

    Rochester: Lewis R. Roberts, MB, ChB, PhD 507-538-4877
                        


  5. Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial

    Rochester, Minn. View Summary

    Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    We hypothesis that removing the foley catheter within 48 hours after a thoracotomy in patients that have an epidural catheter will result in an increase in the rate of urinary infections and the need for reinsertion of the foley. We have designed a randomized trial to test this hypothesis.

    NCT ID:

    NCT01611519

    IRB Number:

    11-006618

    Who can I contact for additional information about this study?

    Rochester: Karlyn Pierson, RN 507-538-1960
                        


  6. Strategic Timing of AntiRetroviral Treatment

    Rochester, Minn. View Summary

    Strategic Timing of AntiRetroviral Treatment

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Background: - Most guidelines agree that if the number of your CD4+ cells (cells in your blood which help fight infection) drops below 350 cells/mm3, or if you have symptoms of AIDS, you should start taking HIV medicines. There are randomized trials that support this recommendation. (Randomized trials are usually considered the strongest form of evidence to support treatment decisions. Other studies, like observational studies, provide evidence too, but the evidence is often considered to be weaker than evidence from randomized trials. A randomized trial gives the most certain information about how well a treatment works because randomization makes sure each group is similar except for the treatment they receive.) Some experts believe that HIV treatment should be started even when the number of CD4+ cells is above 350 cells/mm3. For example, guidelines issued in the US in December 2009 include a new recommendation for starting HIV medicines if your CD4+ cell count is between 350 and 500 cells/mm3. However, this recommendation is based on information from observational studies, not randomized trials. We are doing this study to find out if the chances of getting a serious illness or of getting AIDS are less if people start taking HIV medicines at a time when their CD4+ cell counts are still fairly high, instead of waiting to take HIV medicines at a CD4+ count where there is good evidence for starting medicines. Objectives: - To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their CD4+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines. - To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction. Eligibility: - Patients 18 years of age and older who are infected with HIV, have CD4+ cell counts of greater than 500 cells/mm3, and who have never had antiretroviral therapy to treat HIV. Design: - Initial screening visits (2) to draw blood for CD4+ cell counts and provide a full medical history - Patients will be randomly split into two groups: Early: Patients will begin receiving HIV medications from the start of the study. Deferred: Patients will begin to take HIV medications when the CD4 drops below 350 cells/mm3, or they develop AIDS or other symptoms of HIV infection. - HIV medications for each patient will be determined by the study doctors. - Evaluations during the treatment period: - Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. - Questions about daily life, including sexual behaviors. - Blood and urine tests. - Heart tests with electrocardiogram. - Patients will return for evaluations at 1 and 4 months after randomization, and every 4 months thereafter for the duration of the study. Substudies will take advantage of the START randomization to compare outcomes in people starting ART early vs. later. The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm(3) in terms of morbidity and mortality in HIV-1 (subsequently referred to as HIV) infected persons who are antiretroviral naive with a CD4+ count above 500 cells/mm(3). The study will enroll an estimated 4,000 participants. Participants will be followed for at least 3 years after enrollment, to a common closing date. Substudies will take advantage of the START randomization to compare outcomes in people starting ART early vs. later. These will measure outcomes that do not require the entire sample size of START to determine whether early ART is related to a difference in these outcomes over the course of the study.

    NCT ID:

    NCT00867048

    Who can I contact for additional information about this study?

    Rochester: Mary A. Johnson, CCRP 507-538-6511
                        


  7. Clinical and Economic Impact of a Rapid Test for Detection of Methicillin-resistant Staphylococcus Aureus (MRSA) From Sterile Sites (the Alere™ PBP2a)

    Rochester, Minn. View Summary

    Clinical and Economic Impact of a Rapid Test for Detection of Methicillin-resistant Staphylococcus Aureus (MRSA) From Sterile Sites (the Alere™ PBP2a)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The objective of this study is to evaluate the impact of the Alere™ PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection.

    NCT ID:

    NCT02027389

    IRB Number:

    13-008045

    Who can I contact for additional information about this study?

    Rochester: Ritu Banerjee, MD, Ph.D 507-255-8464