Active clinical trials for "Communicable Diseases"

Hand hygiene (HH) appears to be a simple, non-complex procedure to prevent healthcare-associated infections (HAIs), implementation in daily routine is difficult. The residential setting and specific population pose challenges to optimal HH compliance. This study aims to develop and to evaluate an evidence based multi-component implementation strategy aimed at the promotion of HH in Dutch nursing homes(NHs). A strategy to improve HH compliance in Dutch NHs will be developed. This strategy addresses the specific barriers and facilitators of NHs' infrastructure, healthcare workers (HCWs) and socio-cultural setting. The strategy will be tested in a stepped wedge cluster randomized design which is based on a random sequential roll-out of the implementation strategy to all participating NHs (n=20) for comparison. Data are collected during six consecutive four month periods with an initial baseline period for all NHs. During each period 1200 opportunities for HH are observed, using the gold standard of direct and unobtrusive observations, according to the Five Moments for HH of the World Health Organization. HAIs incidence densities, collected in the sentinel surveillance network for infectious diseases in nursing homes (SNIV), will be evaluated in parallel. A multi component implementation strategy, combining activities aimed at individual HCWs, teams and the organization will be used. The individual level includes education, skills, action planning, reminders and feedback. The team level includes activities that focus on social influence, strengthening of leadership by gaining active commitment and initiative of ward management. The organizational level addresses the structural context and institutional management support. To assess the cost implications of the CHANGE strategy, an economic evaluation will be conducted from a healthcare perspective. The cost-effectiveness of improved HH, defined here as the costs for the CHANGE strategy minus less costs for treating infections, divided by the difference between HAIs before and after the intervention period, will be calculated. A process evaluation will be performed during and after the intervention to investigate the feasibility of the implementation strategy and to illuminate the mechanisms and processes responsible for the results and their variation within the NHs.

Our study will compare all kidney transplant recipients receiving valganciclovir vs. valacyclovir for one year following kidney transplant and compare: the incidence, magnitude and duration of CMV and EBV viremia in the first year after transplant. the side effects of the anti-viral drugs requiring dose reduction or cessation In addition, we will test renal tissue obtained from any biopsies post-transplant (surveillance or clinically indicated biopsies) by both polymerase chain reaction (PCR) and fluorescence in situ hybridization to assess for latent CMV and/or EBV.

Currently there are few options for skin antisepsis, commercially antiseptic triclosan is mainly used. To have more options, this study is necessary, where investigators will determine the residual effect of 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and choose the one with the best characteristics for skin antisepsis.

Urinary tract infections (UTI) are the most common complications after kidney transplantation. Most series have reported incidence between 20 to 50% during the first year. In the most recent report from our center the incidence was 36.6% during the first 6 months after transplantation. The clinical consequence in the graft survival and the association with immunological rejection has not been well defined. Nevertheless, the association of UTI with high rate of hospitalization and their costs are widely recognized. There is paucity of trials, specially randomized and controlled, comparing antibiotic prophylaxis in this group of patients. In a recently published metaanalysis Green et al. (Transpl Infect Dis. 2011 Oct;13(5):441-7) found only 6 clinical trials well designed, the conclusion was that antibiotic prophylaxis reduced the incidence of UTI and the risk of sepsis. Based in this information, the KDIGO guidelines in transplantation recommend the prophylaxis for UTI with sulfamethoxazole-trimethoprim (SMT). Nevertheless, the rate of bacterial resistance to SMT has been reported above 50% in almost all the series. Fosfomycin-trometamol (FT) is a wall antibiotic (piruvil-tranferase inhibitor) that has shown a good bioavailability, especially in the urinary tract. It has shown a wide antibacterial spectrum, but the important target seems to be enteric bacilli particularly Escherichia coli (the most prevalent cause of UTI). FT has also shown a very good activity against E. coli producer of Extended Spectrum Betalactamases. Recently, the rate of these multi-drug resistant bacteria has increased in our center as evidence of worldwide distribution. In addition, the rate of FT resistance has been stable during the last years (<3%). This phenomenon could be explained because of the properties of this antibiotic, the most important one seems to be related with the unique mechanism of action and the lack to propagate the mechanisms of resistance at least in E. coli. There is only one clinical trial (randomized and controlled), which compared FT with placebo in UTI prophylaxis; 317 women with recurrent UTI (three by year) were included. They found rates of 0.14 and 2.9 episodes/patient/year, respectively (p<0.001). Furthermore, there was no FT resistance during the follow up. Our hypothesis is that in the first six months after kidney transplantation, UTI prophylaxis with FT will show greater efficacy in comparison with SMT. Considering the incidence of UTI in our center (36.6%) and the rate of UTI in the unique trial of prophylaxis with FT (14%), 65 patients will be needed by group of treatment to demonstrate a difference of 22% in the incidence of UTI, with a power of 80% and confidence level of 95%. The primary outcome is the incidence and rate of UTI during the first six months after kidney transplantation. The secondary outcomes are, the hospitalization rate, antibiotic resistance rate, rejections and titer and number of de novo donor specific antibodies. The investigators propose a randomized, double blind, placebo controlled trial to compare FT with SMT in the efficacy and safety to prevent UTI during the first six months after kidney transplantation. The investigators will include patients from two tertiary-care transplant centers. Recruiting and the randomization will be carried out separately by center and gender (because female patients have a greater risk of UTI). The medical visits will be scheduled monthly and include general laboratory, urine culture and information gathering about antibiotic side effects as well as adherence. Rejection rate and the number and titers of de novo donor specific antibodies (secondary outcome) will be obtained according to the standard of care of the institutional kidney transplantation follow up. These include kidney biopsy at days 0 and 90 after transplantation, as well as determination of donor specific antibodies after sixth months of follow up. Graft biopsy is also performed whenever graft dysfunction exists in the absence of an identifiable cause (infection, urinary graft obstruction).

Screen-and-treat approach reduces postabortal pelvic inflammatory disease after induced abortion, and at the same time alters women's sexual behavior and prevents further re-infection by sexually transmitted infections when compared to the universal antibiotic prophylaxis strategy.

Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum infections compared to women undergoing vaginal delivery. In Denmark the incidence of post-CS infections is 7-10%. The most common infections are endometritis, Urinary tract infections (UTI) and wound infections (WI). Prophylactic antibiotics are effective in preventing postoperative infections and national guidelines recommend that antibiotics should be administered as a single dose immediately before surgical incision. CS is an exception to this pre-incision administration approach. National guidelines recommend administration of antibiotics after umbilical cord clamping to avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic prophylaxis for CS suggest that prophylactic antibiotics administered before incision compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on the baby and on late infection in the mother. This study is a double-blinded randomized controlled trial with a concurrent Health Economic Assessment. The study will examine the effect of change in timing of prophylactic antibiotics on the rate of post-CS infections (endometritis, UTI and WI). The study will be performed at the obstetric departments at Odense University Hospital (OUH), Hvidovre Hospital (HH) and Hospital South West Jutland (HSWJ) in collaboration with the Department of Clinical Microbiology, OUH, to ensure that the most appropriate antibiotic regime is used. Furthermore, collaboration with a neonatologist will ensure appropriate assessment of neonatal outcome. The investigators plan to enroll the first patient at OUH February 2013. HH and HSWJ will follow with a couple of months delay. The inclusion period is scheduled to last until the investigators have 2844 participants, who have answered the questionnaire. The investigators expect to complete the inclusion period in October 2014 (last patient last visit, LPLV). Microbiological analyzes and data processing is expected to be completed one year after the LPLV. The study population is all women delivering a child by CS during the project period, at Department of Gynaecology and Obstetrics of OUH, HH and HSWJ. Objective: Investigate whether and by how much antibiotics administered 15-60 minutes before incision versus after umbilical cord clamping reduces the rate of postpartum infections in a Danish population of women undergoing CS. Hypothesis: Antibiotics administered pre-incision will result in fewer postoperative infections than antibiotics administered after the umbilical cord is cut. Hypothesis: Antibiotics administered before incision are cost-effective, compared to administration after umbilical cord clamping, measured by post-CS infection and as cost per Quality Adjusted Life Year (QALY).

A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy adults, 18-60 years of age.

Primary Research Questions: Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be assessed. Under efficacy, this pilot will determine whether levofloxacin can decrease the incidence of BK viruria and peak urine BK viral load. Under safety, this pilot will determine the incidence of adverse events with levofloxacin. 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

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.

Many solutions are used for cleaning the skin of a patient previous to a surgery. Although the efficacy of clorhexidine has been proved in other surgical procedures, there is only a retrospective study in cesarean section (they report no benefit of one solution over the other). The investigators would like to evaluate the difference in surgical site infection in patients after cesarean section comparing preparation of the skin with clorhexidine versus povidone.