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NCT ID: NCT03559569 Recruiting - Clinical trials for Cardiovascular Diseases

Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States

Seneshock
Start date: January 7, 2019
Phase:
Study type: Observational

Circulatory shocks (CS) are life-threatening, acute organ dysfunction. Advances in critical care medicine have decreased early hospital mortality, increasing the number of surviving patients. Regrettably, these survivors are at increased risk of new infections but also of cardiovascular disease. The investigators hypothesize that CS with multi-organ dysfunction is associated with premature senescence of endothelial cells and immune cells and promotes endothelial thrombogenicity and immunosenescence leading to cardiovascular disease and secondary infections. The aim of this work is therefore to evaluate the contribution of endothelial and leucocytes senescence to the occurrence of secondary events (infectious and cardiovascular) in patients with a CS. It will provide a better understanding of the pathogenesis of cardiovascular and immune diseases following a CS, likely to guide new management strategies to prevent their occurrence.

NCT ID: NCT03557840 Recruiting - Infection Clinical Trials

Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients

TEMODELTA
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Multidrug resistance towards Gram-negative pathogens makes essential the re-examination of older compounds. Temocillin is a penicillin originally marketed in the 1980s but then largely abandoned. It, however, shows a marked ß-lactamase stability (including most classical and extended-spectrum TEM, SHV, CTX-M enzymes and AmpC ß-lactamase). Temocillin is approved for the treatment of bacterial infections of the chest, the lungs, the kidney, the bladder, as well as bacterial infections of the bloodstream and wound infections. Temocillin efficacy depends primarily from the time interval during which the unbound plasma concentration remains above the minimal inhibitory concentration (MIC) of the antibiotic against the target organism(s). Unfortunately, no comprehensive pharmacokinetic data are available in non-critically-ill patients. The primary objective of the study is characterize the pharmacokinetics of total and unbound temocillin in non-ICU patients, and, on this basis, to propose optimized dosage regimens in this population. The secondary objectives are (i) to look for possible correlations between the plasma protein profile and the unbound temocillin concentrations; (ii) to investigate the impact of the level and nature of circulating plasma proteins on the unbound temocillin concentration. The study will be non-randomized, uncontrolled, prospective, open label, interventional, and monocentric. It will include a population pharmacokinetic-pharmacodynamic analysis of the data obtained. The study will enroll patients ≥ 18 years in need of a treatment with temocillin for (i) complicated urinary tract infection and pyelonephritis (associated or not with bacteremia), or (ii) lower respiratory tract infection, or (iii) abdominal infection, and requiring ≥ 4 days of hospitalization. Blood samples will be obtained at day 0 (control) and after 2 and 4 days of drug treatment (full pharmacokinetic evaluation over 8 to 12 h post-administration). Total and unbound temocillin concentrations in plasma will be quantified by a validated analytical method. A population pharmacokinetic/pharmacodynamics model of plasma total and unbound concentrations of temocillin will be obtained by Bayesian algorithms using Pmetrics software, driven by the predicted plasma total and unbound concentration. The model will be used to assess the probability of target attainment of temocillin.

NCT ID: NCT03555526 Recruiting - H Pylori Infection Clinical Trials

Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

Start date: December 15, 2017
Phase: Phase 4
Study type: Interventional

The inviestigators aimed to compare the efficacy of genotypic resistance guided versus susceptibility testing guided therapy in the third line treatment for refractory H. pylori infection. Hypothesis:The investigators hypothesized that genotypic resistance guided sequential therapy is non-inferior to empiric therapy in the third line treatment for refractory H. pylori infection. Methods: This multicenter, open label, parallel group, randomized trial will be conducted since 2017.07.20. Adult (≥20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled. Genotypic and phenotypic resistances will be determined in patients who failed from at least two eradication therapies by polymerase-chain-reaction with direct sequencing and E-test and agar dilution test, respectively. Eligible patients will be randomized into either one of the treatment groups (A) genotypic resistance guided therapy; or (B) susceptibility testing guided therapy. Outcome Measurement The primary outcome is the eradication rate in the third line treatment (genotypic versus susceptibility testing guided therapy) according to intention-to-treat (ITT) analysis.

NCT ID: NCT03549312 Recruiting - HIV/AIDS Clinical Trials

Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy

Start date: February 1, 2018
Phase: Phase 4
Study type: Interventional

The study hypothesis is to determine the feasibility of switching HIV-HCV co-infected patients receiving methadone or buprenorphine/naloxone as opioid substitution therapy with suppressed HIV RNA viral load on current antiretroviral therapy to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF, Genvoya™) followed by 12 weeks of HCV antiviral therapy with sofosbuvir/velpatasvir (SOF/VEL, Epclusa™), followed then by switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, Biktarvy™) for an additional 48 weeks.

NCT ID: NCT03548740 Recruiting - Clinical trials for Papillomavirus Infections

Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection

Start date: September 1, 2018
Phase:
Study type: Observational [Patient Registry]

Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.

NCT ID: NCT03545919 Recruiting - Clinical trials for Lung Transplant Rejection

Clinical Significance of Community-acquired Respiratory Virus Infection and Longitudinal Analysis of the Lung Microbiome in Lung Transplantation

Start date: August 5, 2018
Phase:
Study type: Observational

The purpose of this study is to evaluate the clinical significance of community-acquired respiratory virus (CARV) infection in patients with lung transplantation;Explore the lung microbiome dynamics within one year after lung transplantation;Find the relationship between lung microbiome and chronic lung allograft dysfunction(CLAD).

NCT ID: NCT03545542 Recruiting - Neuroblastoma Clinical Trials

Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma

Start date: May 7, 2018
Phase: N/A
Study type: Interventional

Background: Malignant tumors may lead to a catabolic state with loss of muscle and adipose tissue. The full picture of catabolism is termed cachexia and is associated with significant morbidity and mortality of cancer patients. Although the full picture is rarely observed up to 50% of children with cancer suffer from significant malnourishment. Additionally to tumor-induced catabolism, side-effects of chemotherapy may be problematic for the patients. In this regard up to 60% of children suffer from gastrointestinal mucositis presenting with nausea, vomiting, diarrhea or constipation and abdominal pain. In the worst case, mucositis may lead to bacterial translocation with life-threatening inflammatory response. Clinically this may require a reduction of the dosage or the number of chemotherapy cycles resulting in reduced effectivity. Up to now the therapy of mucositis is only symptomatic. Recent research of the applicant has shown a significant reduction of Lactobacilli in mice with neuroblastoma (a malignant childhood tumor). The dysbiosis was associated with catabolism, increased gut permeability and inflammation. Astonishingly, chemotherapy alone also leads to a significant reduction of Lactobacilli compared to sham mice, which may be linked to the development of mucositis clinically. Overall, the intestinal microbiome seems to play an essential role in the development of tumor-associated catabolism and chemotherapy-induced mucositis. Aim: The aim of this project is to determine if the changes in the intestinal microbiome observed in mice can also be seen in children with neuroblastoma. Methods: One part of the study will include 10 children with neuroblastoma (inclusion after verification of the diagnosis) and 10 healthy controls. The fecal microbiome will be determined by 16S-ribosomal deoxyribonucleic acid (rDNA) pyrosequencing. Volatile organic compounds in the breath will be sampled and measured by Gas Chromatography/Mass Spectroscopy. A basic science human work package will address the question if there are differences. In the second part serial investigations in children with neuroblastoma will assess whether or not these patients show alterations of the intestinal microbiome under chemotherapy.

NCT ID: NCT03529760 Recruiting - Clinical trials for Reactivation of Hepatitis B Virus

Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia

Start date: May 8, 2018
Phase:
Study type: Observational

Children with clinically diagnosed leukemia may experience occult HBV infection after chemotherapy immunosuppressive therapy, which may affect the normal course of leukemia treatment. However, this is not caused by clinically relevant diagnosis and treatment measures but exists in vivo.

NCT ID: NCT03524794 Recruiting - Hepatitis C Clinical Trials

HepCare: The Effectiveness of Community Based Interventions With Peer Support to Improve Case Detection, Carry Out Pre-treatment Assessments and Assist Underserved Populations Through HCV Treatment

Start date: August 8, 2017
Phase:
Study type: Observational

Hepatitis C infection is a major cause of chronic liver disease and death with approximately 3% of the world's population is infected with hepatitis C virus (HCV). New drug therapies called new direct-acting antivirals (DAAs) have been developed and have proven to be well tolerated with minimal side effects. The current costs of these agents are extremely high, however, they provide an opportunity to cure most patients of HCV if they can access and adhere to treatment. The bigger challenge is to engage and cure underserved groups who are not accessing medical care, or who have other complex problems, including homelessness, incarceration, and substance misuse problems. Strategies to improve HCV case detection and case management have much to learn from other infectious diseases. Tuberculosis (TB) disproportionately affects in large part the same group of individuals and community models of care have been used with great success. Strategies such as active case finding, community based screening and treatment, directly observed therapy (DOT) and peer support have all shown high rates of case detection and treatment completion. These strategies are currently being used by the Find&Treat team, UCLH NHS Trust and this study will ain in evaluating it's effectiveness. Previously used to aid homeless patients engage with treatment services for TB, it is now being used with other disease groups such as HCV. This observational study aims to assess the effectiveness of community based interventions with peer support to improve case detection, carry out pre-treatment assessments and assist underserved populations through HCV treatment by the Find&Treat service.

NCT ID: NCT03524222 Recruiting - Asthma Clinical Trials

Home Hospital for Suddenly Ill Adults

Start date: January 18, 2018
Phase: N/A
Study type: Interventional

The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.