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NCT ID: NCT01459081 Completed - Clinical trials for Influenza A Virus Infection

Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

Start date: October 2011
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections in China.

NCT ID: NCT01458223 Completed - Clinical trials for Postoperative Infection

The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain

PARISS
Start date: October 2011
Phase: Phase 4
Study type: Interventional

Post-operative antibiotics for infection prophylaxis are routinely given to most surgical patients, and for orthopaedic surgery patients, the standard of care is treatment for 24 hours following any elective procedure (1). The most concerning risk for insufficient antibiotic coverage in the post-operative period is the development of a complicated infection requiring irrigation and debridement or revision surgery. Moreover, recovery from surgery is usually delayed in patients that have postoperative wound infections leading to increased resource utilization and increased economic cost for the health care system. It is clear that prophylactic antibiotic therapy is necessary in the immediate post-operative period, but the length required continues to be debated. Orthopaedic patients undergoing elective spine surgeries often require the placement of a hemovac drain which applies gentle suction to remove excess fluid/blood and to promote healing. Wound drains, however, may also increase the risk of post-operative infection because they expose the "clean" interior aspect of the wound to the "dirty" exterior area around the wound. Given this additional focus of infection, it is unknown whether prolonged antibiotic therapy post-operatively is needed to decrease the rate of infection in this population (2,3). There is sparse literature evaluating the effectiveness of prolonged antibiotic therapy in decreasing complicated post-operative infection requiring irrigation and debridement in this population (1,4). To our knowledge, there are no recent studies comparing prophylactic antibiotics for 24 hours only post-operatively versus 24 hours after removal of the drain. In fact, a recent evidence-based review of the literature by the North American Spine Society highlighted the need for research in this area (5). The proposed study will compare two patient populations who will receive various lengths of post-operative antibiotics. One will receive only 24 hours worth, and the other will receive antibiotics for 72 hours after surgery and the rate of complicated infection compared between the two. The absence of a demonstrable difference suggests that antibiotic prophylaxis for only 24 hours immediately post-operatively is sufficient for all elective spine patients undergoing posterior spine procedures requiring the placement of a hemovac drain.

NCT ID: NCT01454960 Completed - Clinical trials for Acute Respiratory Infections (ARIs)

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

BEARI
Start date: July 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 EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives); Accountable Justification (AJ) triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions ; and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison). 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: NCT01454713 Completed - Infection Clinical Trials

Retrospective Analysis of Veritas in Breast Reconstruction

RAVE
Start date: October 2010
Phase: N/A
Study type: Observational

Retrospective data collection of the use of Veritas in breast reconstruction surgery

NCT ID: NCT01453075 Completed - Clinical trials for Chronic Hepatitis C Infection

Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)

Start date: November 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to study the effects of valacyclovir on patients who have hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which causes genital herpes. Some persons with genital herpes have sores in their private areas but most persons do not have any symptoms at all. Valacyclovir is a medication which is commonly used to treat or prevent outbreaks of genital herpes. This medication is already approved by the Food and Drug Administration to treat genital herpes. Valacyclovir has not been approved to treat chronic hepatitis C. The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and the persons participating will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 3-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center.

NCT ID: NCT01450800 Completed - Clinical trials for Urinary Tract Infection

Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI)

STOPP UTI
Start date: August 2011
Phase: Phase 4
Study type: Interventional

This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.

NCT ID: NCT01447407 Completed - Candidiasis Clinical Trials

Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine

Start date: September 2011
Phase: Phase 1
Study type: Interventional

This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID) compared to placebo delivered ID.

NCT ID: NCT01446926 Completed - Pneumonia Clinical Trials

Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants

Start date: September 2011
Phase: Phase 1
Study type: Interventional

This study is designed to explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment. Primary Objective: - To evaluate the safety and tolerability of an investigational pneumococcal vaccine. Secondary Objective: - To evaluate the immunogenicity of an investigational pneumococcal vaccine.

NCT ID: NCT01446289 Completed - Bacterial Infection Clinical Trials

Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.

NCT ID: NCT01445678 Completed - Clinical trials for Complicated Intra-abdominal Infection

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections

Start date: December 23, 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections (cIAI).