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NCT ID: NCT01963000 Completed - Pneumonia Clinical Trials

Standardized Emergency Care for Community Acquired Pneumonia (CAP)

Start date: January 2007
Phase: N/A
Study type: Observational

Community acquired pneumonia (CAP) is associated with a high in-hospital mortality. Standardization of diagnostics and adherence to sepsis bundles in the emergency department (ED) are associated with reduced mortality in patients with sepsis. Investigators examined whether the introduction of standardized care bundles and check lists in the ED are associated with a reduced mortality rate in patients hospitalized for CAP. This is an observational trial. The investigators retrospectively analyzed performance indicators of 2819 consecutive patients with CAP admitted to the Nuremberg Hospital, Germany, from 2008 to 2009. At the turn of the year, implementation of CAP care bundles took place including interprofessional education, checklists and institutionalized feedback. Primary endpoint was in-hospital mortality of CAP patients. After the implementation of CAP care bundles in the ED, mortality of affected patients was significantly lower in 2009 compared to 2008. This study should demonstrate that the implementation of a standardized CAP care bundle in the ED is associated with a risk reduction in affected patients. Standardization of diagnostic and therapeutic processes in the ED therefore improves the outcome of patients hospitalized for CAP.

NCT ID: NCT01958463 Not yet recruiting - Clinical trials for Clostridium Difficile Infection

Transplantation of Fecal Microbiota for Clostridium Difficile Infection

Start date: November 2013
Phase: Phase 3
Study type: Interventional

Recent data have demonstrated beneficial health outcomes of microbiota transplantation for the treatment of Clostridium Difficile infection. The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.

NCT ID: NCT01958281 Completed - HCV Infection Clinical Trials

Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency

Start date: October 7, 2013
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic renal insufficiency (impaired kidney function).

NCT ID: NCT01958073 Completed - Clinical trials for Recurrent Urinary Tract Infection

Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women

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

The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).

NCT ID: NCT01957878 Completed - Clinical trials for HUMAN PAPILLOMA VIRUS

Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL

RHEIA-VAC
Start date: December 2013
Phase: Phase 2
Study type: Interventional

Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential. This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream). ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant. The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.

NCT ID: NCT01957761 Completed - Clinical trials for Clostridium Difficile Infections

Molecular Epidemiology of Clostridium Difficile Infections in Children

Start date: October 2012
Phase: N/A
Study type: Observational

Objectives: 1. Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area. 2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children. 3. Define the risk factors for recurrent and community-associated Clostridium Difficile infection in children.

NCT ID: NCT01952964 Unknown status - Clinical trials for Signs and Symptoms of Exit Site Infection

The Effects of Anti-microbial Spray Dressing in Preventing Tenckhoff Catheter Exit Site Infection for End Stage Renal Failure Patients

JUCspray
Start date: March 2011
Phase: N/A
Study type: Interventional

The present study aims to compare the differences in exit site infection between patients receiving spray dressing and conventional care. The outcome measures including catheter exit site infection rate, skin allergy, catheter damage and patient satisfaction

NCT ID: NCT01952470 Completed - Clinical trials for Lower Respiratory Tract Infection

Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant.

Start date: October 31, 2013
Phase: Phase 2
Study type: Interventional

Patients who have undergone lung transplantation are at an increased risk of developing chest infections due to long-term medication suppressing the immune response. In other chronic lung diseases such as cystic fibrosis (CF) and bronchiectasis, inhaled, nebulised mucolytic medication such as dornase alfa and isotonic saline are often used as part of the management of lung disease characterized by increased or retained secretions. These agents act by making it easier to clear airway secretions, and are currently being used on a case-by-case basis post lung transplantation. To the investigators knowledge, these agents have not been evaluated via robust scientific investigation when used post lung transplant, yet are widely used in routine practice. Patients post lung transplant must be investigated separately as they exhibit differences in physiology that make the clearance of sputum potentially more difficult when compared to other lung diseases. Lower respiratory tract infections are a leading cause of hospital re-admission post lung transplant. Therefore, this highlights the need for a randomized controlled trial. The aim of this study is to assess the efficacy of dornase alfa, compared to isotonic saline, in the management of lower respiratory tract infections post lung transplant. Investigators hypothesize that dornase alfa will be more effective than isotonic saline. The effect of a daily dose of dornase alfa and isotonic saline will be compared over a treatment period of 1 month. Patients admitted to hospital suffering from chest infections characterized by sputum production post lung transplant will be eligible for study inclusion. Patients will be followed up through to 3 months in total to analyze short-medium term lasting effect. Investigators wish to monitor physiological change within the lung non-invasively via lung function analysis whilst assessing patient perceived benefit via cough specific quality of life questionnaires. These measures will be taken at study inclusion and repeated after 1 month and 3 months. Day to day monitoring will be performed via patient symptom diaries, incorporating hospital length of stay and exacerbation rate. The outcomes of this study have the potential to guide clinical decision-making and highlight safe and efficacious therapies.

NCT ID: NCT01951781 Recruiting - Clinical trials for Nosocomial Infection

Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns

NEOCD64
Start date: June 2013
Phase: N/A
Study type: Interventional

Diagnosis of late-onset sepsis is difficult in the absence of specific clinical signs and biological markers in the infection initial phase .The aim of this study is to determine the performance of a new infection marker : Neutrophil CD64 for early diagnosis in nosocomial infection (NI) in preterm newborns. METHODS : - Monocentric prospective study including preterm newborn infants (<37 weeks of gestationnal age ) with clinical suspicion of nosocomial infection in a neonatal intensice care unit (Neonatal intensive care unit of Montpellier, France). - Patients will be enrolled in the study after informed consents. Rapid and automated CD64 measurment will be realized during the conventional blood sample including C-Reactive Protein (CRP), Procalcitonin (PCT) and blood culture. - Broad-spectrum antibiotic therapy can be started on the advice of clinician and blinded the result of CD64. Patients will be then classed in three groups using CDC criteria (center for disease control) : 1-no infection, 2-infection, 3-possible infection during the multidisciplinary staff. Specificity, sensitivity, negative and positive value of CD64 will be calculated and the performances of CRP, PCT and CD64 will be compared. 153 patients are needed in the study enrolled during a period of 12 months. PERSPECTIVES Neutrophil CD64 monitoring might be help clinicians to manage nosocomial infections in neonates.CD64 allow to integrate in a decision algorithm with the determination of the best cut-off value to faster processing nosocomial infections and could help to reduce unnecessary antibioc therapy. A rapid technique for determination of CD64 should be readily available in our unit.

NCT ID: NCT01950325 Completed - HIV-1 Infection Clinical Trials

VRC 601: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to HIV-Infected...

Start date: August 22, 2013
Phase: Phase 1
Study type: Interventional

This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody. VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is that VRC01 will be safe for administration to HIV-1 infected adults by the intravenous (IV) and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and how long VRC01 can be detected in the blood after it is given. Between 15 and 25 HIV-1 infected adults, ages 18-70 years will be enrolled. There are 4 dose escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40 mg/kg. There is 1 group for SC administration at 5 mg/kg. Each group is expected to include at least 3 participants. Each participant will receive two infusions of VRC01 with about 1 month between doses. Infusions are administered in an inpatient unit and an overnight stay at the NIH Clinical Center is required. No more than one subject per day per group will receive a first infusion of the VRC01 product by the IV route and no more than one subject per week will receive a first infusion of the product by the SC route. Study participation lasts for 24 weeks. Participant health and effect on CD4 count and HIV viral load will be monitored. Samples will be collected and stored for research purposes. ...