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Infections clinical trials

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NCT ID: NCT01454947 Completed - Clinical trials for Acute Respiratory Infections (ARIs)

Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study)

BEARI
Start date: August 2011
Phase: N/A
Study type: Interventional

Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of multi-drug resistant pathogens may be encouraged by provider prescribing behavior. Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum antibiotics can lead to the development of resistant strains. Though providers are adequately trained to know when antibiotics are and are not comparatively effective, this has not been sufficient to affect critical provider practices. The intent of this study is to apply behavioral economic theory to reduce the rate of antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for antibiotics. Specifically targeted are infections that are likely to be viral. The objective of this study is to improve provider decisions around treatment of acute respiratory infections. The participants are practicing attending physicians or advanced practice nurses (i.e. providers) at participating clinics who see acute respiratory infection patients. A maximum of 550 participants will be recruited for this study. Providers consenting to participate will fill out a baseline questionnaire online. Subsequent to baseline data collection and enrollment, participating clinic sites will be randomized to the study arms, as described below. There will be a control arm, with clinic sites randomized in a multifactorial design to up to three interventions that leverage the electronic medical record: Order Sets that are triggered by electronic health record (EHR) workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives); Accountable Justifications triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions (AJ); and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparisons). The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and changes in prescribing rates over time. The intervention period will be over one year, with a one-year follow up period to measure persistence of the effect after EHR features are returned to the original state and providers no longer receive email alerts.

NCT ID: NCT01450631 Completed - Clinical trials for Surgical Site Infection

The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions

Start date: February 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.

NCT ID: NCT01431326 Completed - Hypertension Clinical Trials

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

PTN_POPS
Start date: November 2011
Phase:
Study type: Observational

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

NCT ID: NCT01404312 Completed - HIV Infections Clinical Trials

Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)

Start date: May 23, 2012
Phase: Phase 3
Study type: Interventional

HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.

NCT ID: NCT01376778 Completed - Clinical trials for Congenital Cytomegalovirus Infection

A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

CMV
Start date: April 2012
Phase: Phase 3
Study type: Interventional

Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. Pregnant women, who have not been infected with CMV in the past and become infected during pregnancy (i.e. a primary infection), may cause their babies to get infected with CMV. Babies that are infected may develop permanent disabilities including hearing loss and a small portion will die from the infection. Currently it is not routine practice to screen pregnant women for CMV infection. Additionally, there is no agreement about how to evaluate and manage pregnant women infected with CMV for the first time. There is also no evidence that treatment is beneficial for the baby. The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.

NCT ID: NCT01353339 Completed - Clinical trials for Kidney Transplant Infection

Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study

Start date: December 1, 2011
Phase: Phase 4
Study type: Interventional

Primary Research Questions: Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be assessed. 1. Under efficacy, this pilot will determine whether levofloxacin can decrease the incidence of BK viruria and peak urine BK viral load. 2. Under safety, this pilot will determine the incidence of adverse events with levofloxacin. 3. Under feasibility, this pilot will determine the number of kidney transplant patients randomized over an eight month enrolment period, adherence to the levofloxacin and frequency of patient drop-out and loss to follow-up

NCT ID: NCT01350648 Completed - Hepatitis C Clinical Trials

Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection

Start date: August 23, 2011
Phase:
Study type: Observational

Background: - Hepatitis B and hepatitis C can cause liver damage. They can also cause serious illness, including liver cancer, and even death. This study will follow people who have hepatitis B or hepatitis C. The purpose is to understand more about how these viruses affect the immune system over the long term (up to 10 years). The study will also compare how these viruses affect people who do and do not have HIV, the virus that causes AIDS. Objectives: - To do a long-term study of hepatitis B and hepatitis C infection. - To study the effects of hepatitis B and hepatitis C infection in people do and do not have HIV. Eligibility: - People at least 18 years of age who have hepatitis B or hepatitis C and have a regular doctor for their medical care. Design: - Participants will be screened with a physical exam and medical history. Those who do not have a regular doctor to provide medical care during the study will not be able to take part. - Participants will have yearly visits with study researchers for up to 10 years. These tests will be done at each visit. - Medical history and physical exam. - Questionnaire (optional) on emotions, sexual behaviors, use of alcohol and drugs, and quality of life. - Blood and urine tests, including HIV testing. - Tissue sample collections for those who have had a liver or other tissue biopsy. - Participants may leave the study at any time. They will receive the standard of care from their regular doctor throughout the study.

NCT ID: NCT01338116 Completed - Clinical trials for Nosocomial Infections

Optimal Antibiotic Treatment of Moderate to Severe Bacterial Infections

CDSS
Start date: April 2016
Phase: N/A
Study type: Interventional

Severe bacterial infections are associated with mortality of about 30%. Patients with moderate to severe bacterial infections given early and appropriate empirical antibiotic treatment are at a lesser risk for a fatal outcome, with odds ratios ranging from 1.6 to 6.9. However only about 2/3 of patients worldwide are given early and appropriate empirical antibiotic treatment. About 40% of patients treated with antibiotics are given superfluous treatment. TREAT is a computerized decision support system for antibiotic treatment in inpatients with common bacterial infections. TREAT is based on a state of the art stochastic model of the domain (a causal probabilistic network) and uses a cost benefit model for antibiotic treatment, including costs assigned to future resistance. It was tested in a randomized controlled trial in 3 countries and shown to improve the percentage of appropriate empirical antibiotic treatment while at the same time reduce hospital stay and the use of broad-spectrum antibiotics. The main limitation of TREAT is inherent in the limited information available within hours of presentation. A second attractive approach to improve antibiotic treatment is to use techniques that do not depend on cultures, and thus shorten the time to identification of the pathogen to a few hours only. The LightCycler® SeptiFast test from Roche performs in vitro nucleic acid amplification test for pathogens causing bloodstream infections. The purpose of the clinical trial is to show that the combined system TREAT/PCR assays will improve the outcome of inpatients with moderate to severe bacterial infections, while at the same time reducing the use of broad-spectrum antibiotics, with no or little additional costs. A secondary objective will be to assess the sensitivity and specificity of whole blood PCR, using TREAT as the reference standard.

NCT ID: NCT01304732 Completed - Infections Clinical Trials

Totally Implantable Catheters in Pediatric Hematology-oncology: a Study on Infectious Complications

Start date: January 2011
Phase: N/A
Study type: Observational

This is a retrospective analysis of infection on catheters of pediatric oncology patients.

NCT ID: NCT01298843 Completed - Infections Clinical Trials

Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital

Start date: April 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.