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NCT ID: NCT02437045 Completed - Clinical trials for Bloodstream Infections

Trial of Meropenem Versus Piperacillin-Tazobactam on Mortality and Clinial Response

MERINO II
Start date: April 2015
Phase: Phase 4
Study type: Interventional

Infections of the blood are extremely serious and require intravenous antibiotic treatment. When the infection results from antibiotic resistant bacteria, the choice of antibiotic is an extremely important decision. Some types of bacteria produce enzymes that may inactivate essential antibiotics, related to penicillin, called 'beta-lactams'. Furthermore high level production of these enzymes can occur during therapy and lead to clinical failure, even when an antibiotic appears effective by laboratory testing. However, this risk of this occurring in clinical practice has only been well described in a limited range of antibiotic classes in a type of bacteria called Enterobacter. There is currently uncertainty as to whether a commonly used, and highly effective antibiotic, called piperacillin-tazobactam is subject to the same risk of resistance developing while on treatment. Infections caused by Enterobacter (and other bacteria with similar resistance mechanisms) are often treated with an alternative drug called meropenem (a carbapenem antibiotic), which is effective but has an extremely broad-spectrum of activity. Excessive use of carbapenems is driving further resistance to this antibiotic class - which represent our 'lastline' of antibiotic defence. As such, we need studies to help us see whether alternatives to meropenem are an effective and safe choice. No study has ever directly tested whether these two antibiotics have the same effectiveness for this type of infection. The purpose of this study is to randomly assign patients with blood infection caused by Enterobacter or related bacteria to either meropenem or piperacillin/tazobactam in order to test whether these antibiotics have similar effectiveness.

NCT ID: NCT02435810 Recruiting - Brain Disease Clinical Trials

Inflammatory and Infectious Diseases of the Nervous System

Start date: May 6, 2015
Phase:
Study type: Observational

Background: - Inflammation is how the body reacts to infection or injury. Infections or inflammation in the brain and nerves can be serious. There aren t always good tests to detect this. Researchers want to learn more about how diseases affect the brain and nerves to develop better tests and treatments. Objective: - To learn more about how inflammation and infections hurt the brain and nervous system. Eligibility: - People at least 2 years old with a diagnosis or suspected diagnosis of nervous system infection or inflammation. Design: - For some participants, a clinician outside of NIH will collect blood, tissue, and other samples. These will be sent to NIH and analyzed. - Other participants will have several visits to NIH. Children may not have all these tests. - Participants will have: - Medical history. - Physical and neurological exam. - Blood and urine samples collected. - Saliva collected. They will chew on a piece of sterile cotton for one minute. - Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will get a contrast agent through an intravenous (IV) catheter during the MRI. A needle will be used to guide a thin plastic tube (catheter) into an arm vein. - Lumbar puncture. Skin will be numbed and a needle will be inserted into the space between the bones in the back. Fluid will be removed. - Some participants may have optional study procedures. These may include eye tests, memory and thinking testing, tests with electrodes on the head, or skin biopsy.

NCT ID: NCT02434848 Completed - HIV Clinical Trials

A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses

Start date: July 23, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in HIV-infected individuals, including more rapid progression to cirrhosis and associated complications such as hepatocellular carcinoma. For this reason, as well as the shared routes of transmission between the two viruses, UK and International guidance recommends that all HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately, response rates in this population can be as low as 17.5 - 40% to standard vaccination courses. To improve this response, strategies such as the use of double dose of standard vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders, although there is currently limited evidence for this approach. An alternative strategy is to use vaccines with novel adjuvants such as Fendrix and observational clinical data in the Investigators HIV cohort suggests that response rates can be as high as 81% of individuals achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher than Engerix B and controlled trials are required to confirm whether this approach is warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit better responses would be valuable in optimising future vaccine strategies in this population. The Investigators propose to conduct a randomised, open label, active-controlled pilot study comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV vaccine courses, which will provide the necessary data to design and power a larger multicentre randomised controlled trial. Outcome measures will include the proportion of individuals seroconverting with HBsAb levels >100 following each vaccination course, the magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and the durability of the HBsAb response at 1 year following the end of vaccination.

NCT ID: NCT02424461 Completed - Clinical trials for Acute Male Urinary Tract Infection

Antibiotic Treatment for 7 Days Versus 14 Days in Patients With Acute Male Urinary Tract Infection

PROSTASHORT
Start date: January 25, 2015
Phase: Phase 3
Study type: Interventional

This study will investigate the treatment of urinary tract infection (UTI) in men. The investigators are looking to see if shorter duration of antibiotics (7 days) is not inferior to a longer duration of antibiotics (14 days). The investigators will also study whether longer treatment leads to an increase in antibiotic resistant bacteria in the gut microbiota or an increase in drug side effects.

NCT ID: NCT02422875 Enrolling by invitation - Autoimmune Diseases Clinical Trials

Comparative Autoantibody and Immunologic Cell Marker Study

Start date: August 2012
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to compare immune phenotype, function, and specificity of B lymphocytes from different developmental stages in autoimmune patients to B cells from infectious disease patients and healthy controls.

NCT ID: NCT02408939 Completed - Cardiac Arrest Clinical Trials

Steroids and Post-resuscitation Infectious (Septic) Complications

Start date: March 2015
Phase:
Study type: Observational

Postresuscitation disease is characterized by post-insult systemic inflammation, adrenal insufficiency, and circulatory failure. Such severe pathology may be associated with increased susceptibility to infectious complications and increased risk of death due to postresuscitation septic shock. The latter may be attenuated by stress-dose steroids. In this re-analysis of synthesized randomized clinical trial (RCT) data, the investigators will use individual patient data from two prior RCTs of in-hospital cardiac arrest (NCT00411879 & NCT00729794), in order to determine the effect of stress-dose steroids on the severity of postresuscitation infectious complications, and more specifically, on the risk of septic shock-associated death.

NCT ID: NCT02404311 Completed - HIV Infection Clinical Trials

A Safety and Immune Response Study of 2 Experimental HIV Vaccines

Start date: February 2, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS. 252 people are taking part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study. The investigators are doing this study to answer several questions. - Are the study vaccines safe to give to people? - Are people able to take the study vaccines without becoming too uncomfortable? - How do people's immune systems respond to the study vaccines? (Your immune system protects you from disease.)

NCT ID: NCT02395848 Terminated - Clinical trials for Clostridium Difficile Infection

Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection

Start date: July 2015
Phase: Phase 3
Study type: Interventional

This is a medical research study designed to look at the safety and efficacy of 30-day course of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection). CDI is an infection that results when the normal flora (resident bacteria) of the colon is substantially altered by antibiotic treatment. The decrease in this normal flora allows for the growth of the C. difficile bacteria. Fidaxomicin is an antibiotic which is approved by Health Canada for treatment of CDI. Only patients with a primary case of CDI or 1st episode of recurrent CDI have been studied using a 10-day course of fidaxomicin.

NCT ID: NCT02395159 Completed - Infections Clinical Trials

Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)

IMS
Start date: July 2015
Phase: N/A
Study type: Interventional

Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.

NCT ID: NCT02387606 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.

Start date: May 7, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the antiviral effect of repeated oral dosing of JNJ 53718678 compared to placebo in healthy adult participants infected through inoculation with respiratory syncytial virus (RSV)-A Memphis 37b virus.