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NCT ID: NCT03804736 Active, not recruiting - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection

NCT ID: NCT03803605 Recruiting - HIV-1 Infection Clinical Trials

Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons

Start date: January 2019
Phase: Phase 1
Study type: Interventional

Adult participants (18-64 years old) with HIV-1 Infection on cART with a CD4 T cell count ≥ 350 cells/mm3 and viral suppression for ≥ 24 months will be enrolled on this study. Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours. Each series will last approximately 1 month and the two series will be separated by at least one month. Combination ART is (cART) maintained throughout the study. Participants will be on this study for approximately 36 weeks (or about 9 months). The purpose of this study is to: - Evaluate the safety of two series of a VRC07-523LS infusion followed by multiple oral doses of VOR - Determine if combining VRC07-523LS and VOR can have an impact on non-active HIV virus.

NCT ID: NCT03802461 Not yet recruiting - Infection Clinical Trials

Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization

EFFECT-CPE
Start date: February 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Carbapenemase-producing Enterobacteriaceae (CPE) are bacteria carried in the gastrointestinal tract that are resistant to carbapenems, antibiotics of last resort. CPE infections result in death in 25-50% of cases. Fecal microbiota transplantation (FMT) is the transfer of stool from a healthy donor to a recipient to alter the composition of gut microbes. Early studies support its use for eliminating CPE carriage but definitive studies are lacking. The investigators propose a feasibility pilot for a multicenter, non-blinded randomized trial comparing the effectiveness of FMT with no intervention (standard of care) in eliminating intestinal carriage of CPE. Forty patients with CPE will be randomly assigned to receive FMT by enema or no intervention. Feasibility will be demonstrated by the ability to recruit and retain 40 patients over 12 months, and to provide FMT made at a central site to at least one off-site hospital. The primary clinical endpoint for the full trial is CPE intestinal carriage 3 months after the intervention. Secondary endpoints include: CPE carriage at 1, 6 and 12 months; time to decolonization of CPE; safety; CPE infections over 12 months; and, intestinal carriage of other antibiotic-resistant organisms. Data on the clinical outcomes will be collected but not analyzed in this feasibility study.

NCT ID: NCT03801590 Not yet recruiting - Clinical trials for Infectious Keratitis

Crosslinking in Infectious Keratitis

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

Microbial keratitis is an infection of the cornea that is associated with risk of permanent visual impairment. It can be caused by bacteria, virus, fungus, protozoa and parasites. The common risk factors for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery, preexisting ocular surface disease, dry eyes, lid deformity, corneal sensation impairment, chronic use of topical steroids and systemic immunosuppression .

NCT ID: NCT03801213 Not yet recruiting - Clinical trials for Urinary Tract Infection Bacterial

Evaluation of Urine Samples Obtained by Bladder Stimulation for the Diagnosis of Urinary Tract Infection in Infants

EEStiVeN
Start date: June 2019
Phase: N/A
Study type: Interventional

Urinary tract infection (UTI) is the most common serious bacterial infection among infants. Suprapubic aspiration and bladder catheterization are considered as the gold standard by the American Academy of Pediatrics for the diagnosis, yet it is painful and invasive. In contrast, the bladder stimulation technique has been shown to be a quick and non-invasive approach to collect urine in young infants. Actually, the investigators don't have data on bacterial contamination rates for clean-catch midstream urine collections using this technique

NCT ID: NCT03798925 Recruiting - Pulmonary Infection Clinical Trials

mNGS for Detection of Pathogens for Pulmonary Infection

Start date: August 19, 2018
Phase:
Study type: Observational

Pulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases. Metagenomic Next-generation Sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. The study is designed observationally to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional paradigm of serial tests wil be performed.

NCT ID: NCT03798600 Completed - Critical Illness Clinical Trials

Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment's Optimization

Start date: January 1, 2016
Phase:
Study type: Observational

PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology. Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.

NCT ID: NCT03798574 Recruiting - Clinical trials for Meningococcal Infections

The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults

AMEND
Start date: March 1, 2016
Phase:
Study type: Observational

Aim of Study: To assess the clinical, physical, neurocognitive, economic and societal impact on families from invasive meningococcal disease (IMD) in Australian adolescents and young adults. Hypothesis: 1. IMD in adolescence and early adulthood has a significant impact on survivors and their families compared to controls for outcomes such as poorer physical and mental health, quality of life and educational achievement. 2. IMD imposes a significant financial burden upon individuals, families and society. 3. Serogroup B disease is associated with an increased risk of sequelae. Study design: This is a cohort study with survivors of IMD and non-IMD healthy controls invited to be enrolled in the study. Retrospective IMD cases admitted in the previous 10 years will be identified through each of the participating hospitals (paediatric and adult hospitals). During the course of the study prospective recruitment of IMD cases will also occur at participating hospitals. To be eligible for the study IMD is required to be confirmed by either PCR or culture from blood or cerebrospinal fluid (CSF). Meningococcal foundations/groups will also be approached and asked to advertise and conduct a mail out to their members to inform them about the study. Controls will be selected by "snowballing technique" whereby healthy friends or acquaintances of the enrolled IMD case will be approached by the enrolled participant and information about the study provided to them. Control participants may also be identified from databases at each participating site, through advertising, or meningococcal foundations/group mail out. An assessment of enrolled cases including neurocognitive, psychological, physical examination, and qualitative interview will be conducted at 2 - 10 years post IMD admission. Control cases 17 - 34 years of age will also undergo neurocognitive, psychological, and physical examination.

NCT ID: NCT03798301 Not yet recruiting - Clinical trials for Cytomegalovirus Infections

Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells

Start date: January 2019
Phase: Phase 1
Study type: Interventional

The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections. The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy). Participants will be followed for one year.

NCT ID: NCT03798171 Recruiting - Clinical trials for Peritoneal Dialysis Catheter Infection

Reduction of Exit Site Infection in Peritoneal Dialysis Patients

Start date: May 15, 2018
Phase:
Study type: Observational

In peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit. This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.