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NCT ID: NCT01826526 Completed - Clinical trials for Catheter Related Blood Stream Infections

Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%

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

The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream infections in patients with home parenteral nutrition.

NCT ID: NCT01824992 Completed - HPV Infection Clinical Trials

Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections

Start date: March 2011
Phase: Phase 2/Phase 3
Study type: Interventional

to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type infections and clinical negative conversion. 285 patients with positive high risk HPV infection were randomized into interferon gel group and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in control group.

NCT ID: NCT01824888 Completed - Clinical trials for Infectious Disease Transmission

Efficacy of JUC as Hand Rub Evaluated by Using European Standard 1500

JUC
Start date: June 2012
Phase: Phase 2
Study type: Interventional

JUC is a commercially available wound care spray. It is evaluated for the efficacy when using as a hygienic hand rub following the protocol described in the European standard EN 1500:1997 "Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirement (phase 2/step 2)". A crossover study to compare the JUC solution with 60% (v/v) propan-2-ol by using Escherichia coli K12 NCTC strain 10538 as test organism.

NCT ID: NCT01823289 Completed - Clinical trials for Pulmonary Fungal Infection

An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections

Start date: June 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal infections ([IPFI]; lung diseases caused by fungal infection).

NCT ID: NCT01822977 Completed - Healthy Clinical Trials

The Impact of Proton Pump Inhibitors on the Fecal Microbiome

Start date: March 2013
Phase: Phase 1
Study type: Interventional

The investigators hypothesis is that daily use of a proton pump inhibitor (PPI) is associated with significant alterations in the healthy fecal microbiome that are similar to those seen in persons with an initial episode of clostridium difficile infection (CDI).

NCT ID: NCT01821963 Terminated - Infection Clinical Trials

Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)

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

The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant. Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at different stages of the HCV infection to stop the virus.

NCT ID: NCT01821664 Recruiting - Clinical trials for Prosthetic Vascular Graft Infection

Vascular Graft Infections

VASGRA
Start date: May 2013
Phase: N/A
Study type: Observational [Patient Registry]

Background: Vascular grafts are increasingly implanted due to an increasing prevalence of atherosclerosis and diabetes, and about 1-6% of vascular procedures are complicated by infection. Mortality attributable to prosthetic vascular graft infections (PVGI) is high. However, there are almost no data regarding best treatment options of such complicated infections. Most recommendations are based on expert opinion and not on clinical trials or cohort observational data analyses. Evaluating infectious and other complications after vascular surgery procedures are important, and additionally, such studies may offer insights for quality improvement and improved patient outcomes. With the first aim investigators will establish an infrastructure for studying PVGI in Zurich. Investigators will take advantage of the Swissvasc registry, a central registry which collects preoperative, operative and discharge data regarding the index vascular surgical interventions. They will create a prospective observational cohort database of all patients who receive a vascular graft (peripheral, aortic, vein) at the University hospital of Zurich (VASGRA Cohort A). Patients with a PVGI will be included in VASGRA Cohort B and followed up using a flow chart with a focus on the course of this infectious complication. Additionally, investigators will establish a biobank with the collection of tissue- and blood samples of patients with PVGI. With the second aim researchers will investigate different diagnostic, clinical and therapeutic research questions nested in the VASGRA Cohort. Firstly, they will address epidemiological questions, such as: determine the incidence and outcome of complications after vascular graft placement; determine risk factors, best treatment strategies and outcome of PVGI, and determine the influence of different antibiotic regimens on the outcome of PVGI due to different bacterial pathogens. Secondly, investigators will determine the accuracy of different imaging techniques (PET/CT and MRI) for the diagnosis of PVGI, and their individual role for the assessment of treatment response. Thirdly, investigators will evaluate the bacterial diversity of vascular wound infections using 16s r-Ribonucleic acid (RNA)amplification, and investigators will explore whether this bacterial diversity does predict disease progression. Here, investigators will also study the impact of negative pressure wound therapy (NPWT) on bacterial diversity in the treatment course of PVGI. Fourthly, investigators will look for cut-off levels of relevant blood leucocytes count, C-reactive protein and procalcitonin raising suspicion of a PVGI. Lastly, investigators will look at histopathological features of excised vascular grafts. Expected value of the project: Results from the proposed study are an important contribution to the field, based on the large sample size, longitudinal design and by unifying clinical and epidemiological science. The very well characterized patient groups and the close connection between vascular surgeons, infectious disease specialists, specialists in nuclear medicine and microbiologist will help to investigate PVGI in depths. Investigators hope to be able to develop guidelines regarding best diagnostic modalities and treatment options in case of vascular graft infections. In the future we plan to examine bacteria retrieved from the PVGI in the laboratory in detail. The recovered bacteria will be examined for antimicrobial susceptibility and their capability to form biofilms. Furthermore investigators will examine how bacterial recovery form explanted grafts could be optimized.

NCT ID: NCT01820897 Completed - Clinical trials for Urinary Tract Infection

Efficacy of Fosfomycin-Trometamol in Urinary Tract Infection Prophylaxis After Kidney Transplantation

Start date: April 2013
Phase: Phase 4
Study type: Interventional

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).

NCT ID: NCT01820455 Completed - MRSA Colonization Clinical Trials

MRSA in a Trauma Population: Does Decolonization Prevent Infection?

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

All trauma patients admitted to certain Intensive Care Units (ICU) will have Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA colonization status. Only those patients who are determined to be colonized with MRSA at admission will be included in the study. All patients must be age 18 and older, admitted directly to the ICU from either the Emergency Department or the operating room with trauma-related injuries, and must not have active or recent known history of MRSA infections. Once patients have been determined to be colonized with MRSA, they will be randomized to receive "decolonization" treatment or placebo. "Decolonization" treatment will include Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will entail "routine" soap baths and Lubricating Jelly. Both groups will be kept on standard contact precautions throughout the course of the study. Repeat nasal swabs will be performed at the completion of the treatment regimen to determine the efficacy. Patients will be screened for invasive MRSA infections as dictated by their clinical course. The primary outcome measure will be invasive MRSA infection rate (pneumonia, urinary tract infection, bacteremia and soft tissue infection). Secondary endpoints include hospital lengths of stay, ICU lengths of stay, mechanical ventilatory support requirements, colonization status at the end of treatment, and death rates. As determined by our power analysis, we aim to enroll 75 patients in each arm over the course of 12-24 months.

NCT ID: NCT01820026 Unknown status - Cirrhosis Clinical Trials

Empirical vs 2nd Line Antibiotic Therapy in Health-care Associated Infections in Cirrhosis

Start date: December 2012
Phase: Phase 4
Study type: Interventional

Bacterial infections are a frequent complication in liver cirrhosis with a bad prognosis. However, the clinical outcome of cirrhotic patients with serious infections is significantly improved over the last 30 years due to early diagnosis and to the use of a more appropriate antibiotic therapy. As in the general population, empirical treatment should be initiated soon after diagnosis, after making the necessary sampling and should be based on the use of an antibiotic with low toxicity and broad spectrum antibacterial efficacy, taking into account the local epidemiology and prevalence of antibiotic resistance. The third generation cephalosporins are considered the gold standard in the treatment of most infections in cirrhotics due to their effectiveness against enterobacteriaceae and against non-enterococcal streptococci and due to their low toxicity. However, the recommendations for the antibiotic therapy are currently based on results of trials of '80s and '90s, when the proportion of resistant pathogens was lower. Similarly to nosocomial infections, the increasing rate of infections due to multidrug resistant (MDR) bacteria represents the rational for a different choice of empirical antibiotic therapy with a higher resistance barrier. This change in the epidemiology of community acquired infections is mainly due to the increased contacts with healthcare system of these patients and for the larger use of antibiotic prophylaxis. With this regard, it was recently proposed to introduce a third epidemiological class of infection "Health care-associated": Infections occurring in community in patients who have been in contact with the health system shortly before the infection. This epidemiological class of infection should be distinguished from "community-acquired" because they are more similar to"nosocomial" in terms of their sensitivity to antibiotics. Therefore for this class should be taken into consideration the use of a different empirical antibiotic therapy. The investigators aim was to evaluate prospectively the effectiveness of a broad spectrum antibiotic treatment in a cohort of cirrhotic patients with "healthcare-Associated"infections Cirrhotic patients with "Healthcare Associated" admitted to the gastroenterology department of the Policlinico Umberto I and in the Department of Hepatology of the Hospital of Marino will be consecutively enrolled. Randomized controlled trial with randomisation stratified by epidemiological class of infection.