View clinical trials related to Infection.
Filter by:The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.
Routine screening for gonorrhoea and chlamydia involves urine samples in males and selftaken vulvovaginal swabs (VVSs) in females. As well as infecting the urethra (pee tube) and cervix (neck of womb), gonorrhoea and chlamydia may also infect the rectum (bottom) and throat (both called extragenital sites), often with no symptoms. In some people infection will be found at more than one site, but in others it will only be in one, and if all anatomical sites are not tested some infections will be missed. In certain women one third of infections may be missed, in men who have sex with men (MSM) up to 90% may be missed, if extragenital swabs are not taken. Currently, routine community testing does not include extragenital sites. Until recently these samples could not easily be taken outside clinical settings (hospitals, clinics or surgeries), but new DNA tests for gonorrhoea, called NAATs, now make this possible. However, they are expensive, and taking samples from extragenital sites would treble the costs. We propose that swabs from the three sites per person are pooled and analysed together rather than tested separately. This method would identify whether the person had the infection but not the anatomical site; this would not alter the management of the individual. Swabs from the rectum and throat have historically been taken by clinicians (doctors or nurses). The main attraction of community screening is that it is client led using selftaken samples. Recent studies suggest that selftaken swabs from the rectum and throat are acceptable to clients and may be as good as swabs taken by clinicians, but the costeffectiveness of this approach has not been investigated. Our aim is to establish whether in MSM and females selftaken samples that are pooled and processed by NAATs are as effective as the individual tests taken by clinicians.
Respiratory and gastrointestinal infections are common in children under the age of 4 years, especially after the start of schooling. These conditions are facilitated by a still incomplete functional maturation of the immune system and the anatomical structure and function of the respiratory and gastrointestinal tract still developing. The frequency and duration of these conditions involves a high discomfort and significant costs, in relation to medical appointments, taking medication, the need for hospitalization, days of absence from school and work days lost by parents. Functional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, with sometimes conflicting results. Diversity in experimental designs, populations evaluated, and bacterial strains used in the preparation of fermented products are probably responsible for these discrepancies. Recently we started a study approved by the Ethics Committee for Biomedical Activities "Carlo Romano" of the University of Naples "Federico II" (protocol number 210/12) to evaluate the effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of common winter infections in school children aged between 12 and 48 months. Studies of pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental colitis. A preliminary analysis of the data was found that subjects treated with fermented milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract infections or gastrointestinal, with a statistically significant difference between the study groups. It was also observed a significant increase in the levels of α- and β- defensins, LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to subjects treated with fermented rice or placebo. Therefore, we decided to extend the period of study of five additional months, in order to perform an evaluation of the effectiveness of fermented milk (which was more effective)vs placebo.
This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo. The objectives are to obtain safety and efficacy data in moderate to severe asthmatic patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human Rhinovirus infection.
Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study
Background: - Ebola is a viral infection that can spread quickly and causes life-threatening disease. Right now there is an Ebola outbreak in many countries in West Africa. There are no approved treatments for Ebola. But possible treatments are being developed. Researchers need to study these treatments to see if they help people get better. Objective: - To identify possible Ebola treatments. Also, to learn if adding 1 or more experimental drugs to advanced Ebola care can reduce the risk of death. Eligibility: - People who have recently been diagnosed with Ebola, usually by a test called the Polymerase Chain Reaction (PCR), and have been hospitalized in an isolation unit for treatment. Design: - Participants will be randomly assigned to Group A or B. Both groups will get advanced level care. One group will also get an experimental drug. - Participants may have blood tests. They may have another PCR test. - Researchers will try to learn how the participant got Ebola. - Participants put in the experimental drug group may start taking medicine within 24 hours of enrollment. It may be given by mouth or intravenously. Additional doses may be needed. - Participants may have a series of timed blood tests over the first 24 to 48 hours after they take the medicine. - Blood will be drawn frequently. Other body fluids (urine, stool, vaginal fluid, etc.) may also be collected. - Participants will be followed for up to 60 days. They may be evaluated for any long-term effects of the experimental treatment(s). They may be asked to return for 1 or more outpatient visits. - For consenting participants, follow-up will be extended for up to one full year past Day 58 with contact/visits every 1-3 months to assess for a history of signs or symptoms potentially consistent with late onset of virologic relapse syndrome.
This study is aimed at assessing the safety of candidate Hepatitis C vaccines AdCh3NSmut/MVA-NSmut and HIV vaccines ChAdV63.HIVconsv/MVA.HIVconsv when administered separately or in combination to healthy volunteers. The study also aims to assess the cellular immune response generated by these vaccines when administered as mentioned above.
The concept of acquired immunodeficiency after a first severe infection in the ICU is widely described in the literature. There is a dual risk: increased mortality and increased secondary infections. Several approaches of immunostimulatory treatments have been proposed in the literature. The treatment proposed by this study consists of the administration of Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in Germany in 2009. The main objective is to measure the incidence of ICU-acquired infections in 2 groups of patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3 from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human Leucocyte Antigen DR)with a threshold of less to 8000 sites. Our hypothesis is that the number of secondary infections (primary endpoint) will be significantly reduced in the treated group.