View clinical trials related to Infection.
Filter by:The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.
Invasive bacterial infection is a dangerous but relatively uncommon disease where bacteria spread deep into the body causing diseases like blood poisoning ('bacteraemia'), pneumonia, meningitis and others. The various bacteria of the streptococcus family are an important cause, often leading patients to require intensive care despite which, for some strains, one in five patients die. One notable form is called necrotising fasciitis, a condition where bacteria rapidly spreads through and destroys the layers of tissue just under the skin. As individuals vary greatly in their risk of developing such serious infections, investigating how the genome, the inherited blueprint of our bodies, of these patients differs from that of healthy volunteers can help to explain why the disease develops in some and not others. For some streptococcal bacteria such as Streptococcus pneumoniae this approach is already proving successful; for others such as the "Group A" strain (Streptococcus pyogenes) it has yet to be explored but carries excellent potential. The investigators have secured the support of the Lee Spark Necrotising Fasciitis Foundation to recruit from their membership survivors of streptococcal infections and some of their family members. The investigators will also ask infection specialists from NHS hospitals to invite patients they have looked after. The investigators also have a small existing collection. Taking part would involve registering information on a website, discussing the study on the telephone and then providing us with a sample of saliva from which the investigators can isolate DNA. The investigators would prepare the sample for analysis of the genome and compare the patients with both their family and an existing reference collection from healthy volunteers using technology that reads the DNA code. Our study will be a first key step in renewing efforts to understand the determinants of invasive streptococcal infection, which is important for developing better treatments and vaccines.
This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. The investigated assay measures the levels of a few host-related, blood-based, bio-markers that will be integrated into a single score. Based on this score, each patient will be classified into one of three categories: (i) bacterial immune response, (ii) viral immune response, and (iii) marginal immune response. The assay prediction and the patient diagnosis will than be unveiled and compared to determine their level of concordance.
The respiratory and gastrointestinal infections are a very common problem with high morbidity in children. These conditions were due, in general, immaturity and all "inexperience" of the immune system, as well as to the particular anatomical structure and function of the respiratory and gastrointestinal tract still developing. This inevitably means that school-age children develop disease (as a result of infection) more easily than at later ages. The frequency and duration of these conditions implies a high discomfort and incur significant costs in relation to drug administration, the need for hospitalization, days of absence from school and work days lost by parents. Recently probiotics, defined as "microorganisms that prove able, once ingested in adequate amounts, exert beneficial functions for the body "have been proposed for the treatment of treatment of respiratory and gastrointestinal infections of childhood but only in recent years have been conducted controlled clinical trials that have conclusively proven effectiveness. All probiotics induce an immune response, the characteristics of which are related to the strain or the mixture of bacteria used. Recent studies have demonstrated positive effects of probiotics on the respiratory system, and in particular on the prevention and reduction of the severity of respiratory infections, probably mediated by an increase of cells that secrete Immunoglobulin A in bronchial mucosa. It 'been shown that probiotics can be a sure way to reduce the risk of early acute otitis media and the use of antibiotics for recurrent respiratory infections during the first year of life. Similar results were seen in a study conducted on a population of 326 children aged between 3 and 5 years, who found a decrease in the incidence of antibiotic use by over 65% and a reduction of days of absence of more than 25% among children treated with a probiotic. Many of the studied effects of probiotics, understandably, refer to the digestive system. These effects relate to both conditions paraphysiological (constipation) and more specifically in situations of illness. Most of the studies carried out in recent years has demonstrated the efficacy of specific probiotics in reducing the symptoms in the pediatric population affected by infectious gastroenteritis. Probiotics reduce the duration of infectious diarrhea by 0.7 days and reduce the frequency of diarrheal episodes in the first few hours. The microbiota on the other hand participates in the function of the mucosal barrier against the adhesion of pathogenic bacteria, crucial time for the start of the infectious process. When this barrier function is altered by chemical agents, by antigens or by stressors of different nature, may manifest intestinal disorders, sometimes due to the growth of bacteria pathogens. Numerous experimental data suggest that probiotics can contribute to the reinforcement of the activities of gut mucosal barrier, in particular aspects affecting the functionality of the intestinal epithelial cells or macrophages. More recently it has been shown that daily intake for 3 months of preparation with probiotics reduce the incidence and severity of the most common respiratory infections and limits the number of days of absence school children during the winter season. It's scientifically recognized as some probiotic effects can also be obtained with the use of inactivated bacteria or bacterial components isolated (eg bacterial DNA). It has been recently proposed a modified definition of probiotic products as "prepared bacterial cells or bacterial components that have a beneficial effect on the health and welfare of the host". Among these products "probiotic-like" fall ingredients object of this study: food ingredients (rice flour and skim milk) fermented, or in which has been made to grow a probiotic (Lactobacillus CBA-L74) that has been inactivated at the end of the fermentation process through a heat treatment. The benefits are attributable to bacterial components that remain in the final product (for example, DNA, cell wall, etc.) and factors produced during the fermentation (short chain fatty acids, bacterial proteins, etc.). The main effects of these bacterial components relate to the stimulation of the gastrointestinal tract associated lymphoid tissue (GALT), through interaction with the immune cells via Toll-like receptors. In addition, some components, such as proteins and peptides, may have a Bifidogenic activity and are available in the literature some studies that have demonstrated the ability of infant formula, milk-based fermented to reduce the severity of episodes of infectious diarrhea in children. With this data, the Commission of the European Society of Nutrition Gastroenterology, Hepatology and Pediatric Nutrition (ESPGHAN) has defined this type of products are not only safe but to determine a potential prebiotic effect and the reduction of the severity of episodes of infectious diarrhea.
Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution and the changes in gut microbiota composition. SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV viral load in patients after taking probiotics. Methods: Design: A prospective randomized open controlled double-blinded trial, to be performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients. Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells / ml and undetectable viral load for more than two years (22 cases) and (2) Patients with immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite 4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide levels measured by the Lipid-Binding protein (LBP), parameters of immune activation in plasma (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months. Immunological and clinical data. Outcome measures: quantification of bacterial translocation levels, markers of activity and immune recovery. Analysis: Comparison of variables before and after the intervention. The analysis will be performed by biological and immunological effectiveness.
This trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined.
Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown. Therefore, we aim to compare the eradication rates and long term re-infection rates of quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple therapy for 14 days. Methods: This will be a multi-center, open labeled, randomized control trial Patients: H. pylori infected patients who have willingness to receive eradication therapy Testing for H. pylori infection Before First Line Ttreatment (1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT will be considered as H. pylori infected After First Line Treatment: C13-Urea breath test will be used to assess the existence of H. pylori 6-8 weeks after first line therapy. Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H. pylori 1 year after eradication therapy
This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure prophylaxis (PrEP). All individuals were enrolled and followed as described in the parent PrEP demonstration project or clinical study protocol until study completion, HIV-1 infection, discontinuation due to an adverse event, lost to follow-up, or administrative censoring. In the protocols of the parent PrEP observational or clinical studies, participants had follow-up visits on average every 3 months for evaluation of adherence, renal and bone adverse events, and HIV-1 infection status. Adherence was determined by the specific FTC/TDF drug level measurement(s) outlined in the parent protocol. Gilead had collected data from 21 global PrEP demonstration projects and clinical studies for over 7,000 Truvada for PrEP users who had at least one measurement of adherence. Data from the different contributing studies were pooled for statistical analyses by Gilead.
The objective of this study is to provide treatment with Fecal Microbiota Transplantation (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has been shown that good bacteria (like that found in the stool from a healthy donor) attack Clostridium difficile in multiple ways: they make substances that kill Clostridium difficile - and they attach to the surface of the colon lining, which prevents the Clostridium difficile toxin (poison) from attaching. FMT involves infusing a mixture of saline and stool from a healthy donor into the bowel of the patient with CDI during a colonoscopy. The method used to deliver the FMT will depend on individual characteristics of the subject and is at the discretion of the treating physician. FMT may be administered by the following methods. - Colonoscopy: This method allows full endoscopic examination of the colon and exclusion of comorbid conditions (such as IBD, malignancy or microscopic colitis) which may have an impact on subject's treatment or response to therapy. - Sigmoidoscopy: This method still allows infusion of the stool into a more proximal segment of the colon than an enema, but may not require sedation. This method may be beneficial in subjects who are elderly or multiparous and who may have difficulty retaining the material when given as enema. Sigmoidoscopic administration eliminates the additional risks associated with colonoscopy in subjects who may not have a clear indication for colonoscopy. - Retention enema: This method may be preferable in younger subjects who have already had recent endoscopic evaluation, in subjects who prefer not to undergo endoscopy or in subjects with significant co morbidities and may not tolerate endoscopy. The physician will administer 300-500 mL of the fecal suspension in aliquots of 60 mL, through the colonoscope or sigmoidoscope or 150 mL via retention enema. In cases of colonoscopic delivery, the material will be delivered to the most proximal point of insertion. The subject is encouraged to retain stool for as long as possible.
This multicenter, retrospective, observational study will evaluate the therapeutic effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized regimen of antiretroviral drugs in patients with HIV-1 infection in routine clinical practice.