Search Results Within Category "Infectious Diseases"
MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases
This research is being done to determine whether the investigational drug tabelecleucel (allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes [EBV-CTLs]) can help people with EBV-associated diseases.
• diagnosis of Epstein-Barr Virus (EBV) disorder
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.com for additional inclusion criteria
• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1) (PRIOH-1)
The purpose of this research study is to look at the safety and effectiveness of pritelivir given orally (by mouth for a maximum of 42 days) for people with an impaired immune system who have recurrent lesions caused by the form of HSV that does respond to treatment with acyclovir.
• at least 16 years old
• immunocompromised or body is unable to fight off infection
• have lesions that can been seen in order to determine if they are healing
• willing to use highly effective birth control
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• history or current evidence of gastrointestinal malabsorption
• on hemodialysis for any reason and end stage renal disease (ESRD)
• women who are pregnant or breastfeeding
• unable to communicate with study staff
018 / ACTIV: A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections
We are studying an investigational medicine for treatment of people in the hospital with COVID-19. This medicine is investigational because it can only be used in research. We are trying to find out if this investigational medicine is effective when given in addition to the current standard treatment for COVID-19. We are also trying to make sure it is safe for people who are sick in the hospital to take. The treatment being tested in this study is not yet approved by the U.S. Food and Drug Administration (FDA) or any other national government agency.
• admitted to the hospital with symptoms of respiratory infection
• positive test for SARS-CoV2 infection (COVID) within the prior 14 days
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• expect to be discharged in the next 24 hours
• unable to swallow tablets
• women who are pregnant or breast feeding
• liver or kidney failure
• men and women who are unwilling to use contraception to prevent pregnancy
A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis
The purpose of this study is to learn about the safety and efficacy of PC945 when given in combination with the antifungal therapy that is normally given for this condition, also known as the standard of care (SoC). This study will also assess how PC945 is processed in the body (e.g., distributed, transformed, and removed) by measuring the levels of PC945 in your blood and lungs; this is called pharmacokinetics (PK).
• diagnosis of invasive pulmonary aspergillosis that hasn't responded to treatment
• surgical or medical condition that makes participation difficult or potentially unsafe
• require care in an intensive care unit
Pathogen Genomics Center of Excellence: Prospective Surveillance of Respiratory Pathogens and Antimicrobial Resistance in Diverse Regional Populations (MINNE-LOVE-2)
Respiratory illnesses, including ear and sinus infections, colds, and pneumonias, are among the most common infectious diseases affecting Minnesotans across their lifespan. These diseases can be caused by many different types of microbes—bacteria, viruses and fungi—and different types of microbes may require different kinds of treatment. This research is being done to learn more about the specific types of microbes that cause respiratory infections in children and adults across the state of Minnesota over time. Antimicrobial resistance happens when microbes develop the ability to defeat the drugs designed to kill them. Through this study, we will learn which types of genes are carried by microbes living in the respiratory tract by collecting and analyzing nasal and oral specimen.
• age at least 18 years and able to provide informed consent AND willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness Or
• age less than 18 years within the same household of at least 1 adult participant in study AND parent/guardian available to provide informed consent AND self or parent/guardian willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness
• presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., parent not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe)
• routine mucosal specimen collection is not medically advised (such as severe immunocompromising condition, bleeding disorder)
Quantifying the Individual Heterogeneity of Presentation and Symptoms of Cognitive Impairment in Long COVID
This questionnaire and cognitive task study is being done to learn how different activities, like exercise, sleep, and stress, may affect symptoms of long COVID. We also want to know how symptoms may fluctuate over different times during the day and over several weeks. The study will take about 4 weeks to complete and will be done remotely.
• able to speak English
• have access to a compute with internet access
• history of having COVID-19
• continue to experience symptoms of long COVID-19 such as fatigue, "brain fog", trouble sleeping, headaches, etc.
• never tested positive for COVID-19
A Phase 1 Adaptive, Multiple Dose Pharmacokinetic and Safety Assessment of Valacyclovir in Infants At Risk of Acquiring Neonatal Herpes Simplex Virus Disease
The purpose of this study is to determine the dose of medication (Valacyclovir) needed to prevent an infant from developing herpes simplex virus (HSV) if the infant was potentially exposed to HSV at the time of delivery as they passed through the birth canal.
• Mother has a history of genital HSV infection
• Mother is receiving oral acyclovir, valacyclovir, or famciclovir suppressive therapy for 7 or more days before delivery
• Gestational age 38 or more weeks at birth
• Infant is no more than 2 days of age at study enrollment
• Weight at study enrollment at least 2,000 grams
• Evidence of neonatal HSV infection
• Evidence of sepsis
• Kidney anomalies or dysfunction
• Maternal genital lesions suspicious for HSV at the time of delivery
• Infants known to be born to women who are HIV positive (HIV testing is not required )
• Infant currently receiving acyclovir, ganciclovir, famciclovir, or any investigational drugs
A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome? followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species (OASIS)
This study will look at an investigational study drug, called olorofim, to determine how safe the study drug is, how well it is tolerated and whether it is effective compared to AmBisome® (a standard of care treatment) to treat invasive fungal disease (IFD). We expect that you will be in this research study for up to 18 weeks or just over 4 months.
• over 18 years old
• weigh more than 40 kg (88 pounds)
• Invasive Aspergillosis (IA) at any site
• require therapy with an antifungal agent other than a mold-active azole
• women who are pregnant or breastfeeding
• known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
• people with chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis
• human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy
• certain heart and liver conditions (study staff will review)
The Lung Cell Study (TLC)
The purpose of our research study is to increase our understanding on the human lung immune response to infection. We aim to use this knowledge to develop novel approaches on the prevention and treatment of lung infections. To accomplish this, we plan to obtain cells from the airways and blood of healthy volunteers to perform immune experiments.
•
• Former smokers (quit > 6 months ago) or never smoked, including marijuana
• Between the ages of 18-65 years
• Current or recent illness within the preceding two weeks.
• Presence or prior history of cardiac, pulmonary, or systemic disease
• Bleeding disorder
• Current use of systemic anticoagulant or antiplatelet therapy
• Immunocompromised state (HIV infection, immunoglobulin deficiency, use of systemic immunosuppressant medications)
• Use of any inhaled substance, including tobacco, marijuana, e-cigarettes, cocaine, methamphetamines, or toxic vapors in the past six months or greater than ten pack-year smoking history
• Alcohol use disorder
• Allergy or prior adverse reaction to lidocaine, midazolam, or fentanyl Pregnancy
• Weight less than 110 lbs (for venipuncture)
• Older than 65 years of age
Senolytics To slOw Progression of Sepsis
Researchers hope that using Fisetin, an antioxidant, will reduce inflammation in the body caused by sepsis, which could help your body and organs have more time to recover. Placebo in this study will be something that looks similar to the study treatment, but does not contain any active drug. Everyone will receive 4 pills, but your group will determine how many of the pills are Fisetin. Researchers will look at the potential effects Fisetin or placebo has on inflammation in the body and how sick participants are at 7 days and 28 days.
• Age 65 or older
• Primary diagnosis of acute infection
• Expected length of hospital stay at least 48 hours
• No acute infection
• Known hypersensitivity or allergy to Fisetin
• Not admitted to hospital
• Enrolled in another Sepsis clinical trial
A Retrospective Follow-Up Study of the Durability of Antiviral Therapy on Long-Term Hearing and Neurodevelopmental Outcomes Among Patients Treated for Congenital Cytomegalovirus Infection as Infants or Toddlers
The purpose of this study is to find out if treatment of congenital cytomegalovirus (cCMV) with an antiviral medicine has any impact on hearing, development of cancers, overall development and sexual maturity development. No treatment for cCMV will be provided in this study.
• at least 2 years old
• received intravenous ganciclovir or oral valganciclovir to treat congenital cytomegalovirus (CMV) infection
• may have participated in the CASG study of the treatment of congenital CMV
• unable to comply with study-related procedures
Pediatric COVID-19: Does infection with the SARS-CoV-2 virus alter brain structure and function?
The goal of the proposed project is to investigate whether brain abnormalities are present in children to young adults after the recovery from coronavirus disease 2019 (COVID-19).
• diagnosis of COVID-19 in the past
• experiencing long covid symptoms for at least 2 months
• 3 to 25 years old at the time of entry into the study
• active positive COVID-19 diagnosis (as confirmed by a medical provider &/or certified testing site) for at least 4 weeks prior to projected enrollment date
• surgically implanted pacemaker
• indwelling electronic device, including programmable shunts
• orthodontic braces, unless non-metallic
• implanted metal in the body other than titanium
• inability or unwillingness to complete an MRI
• pregnancy
• anyone not meeting standard MRI requirements according to CMMR protocol (ie presence of metal in body or implanted pacemaker) will be excluded from that portion of the study
A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104
This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.
• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY (RESTORATiVE303)
The purpose of RESTORATiVE303 is to see if the study drug, which is called VE303, is safe and effective in preventing another episode of Clostridioides Difficile Infection (CDI). VE303 is an investigational drug that has 8 strains of live bacteria, called “commensals.” Commensals are the type of bacteria that live in harmony with the body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make one sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.
• at least 12 years old
• laboratory-confirmed Clostridium Difficile Infection (CDI) and at least one prior occurrence of CDI within the last 6 months
• OR 75 years or older with laboratory confirmed CDI
• OR CDI with additional risk factors
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
• history of chronic diarrhea unrelated to CDI
• history of celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months) of intestinal ischemia or ischemic colitis
CLINPRT-7: Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)
The purpose of this open-label Expanded Access Protocol (EAP) is to provide access to MBP134, for treatment of Sudan Virus Disease (SVD). Patients will receive a single IV infusion of 50 mg/kg MBP134. Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events (SAEs), and of all adverse events (AEs) during infusions.
• people of any age who have a documented positive RT-PCR for Sudan Virus Disease (SVD) in the last 10 days
• OR a documented positive RT-PCR test for SUDV more than 10 days ago but continue to have symptoms of SVD
• OR acute symptoms compatible with SVD and a close contact with some who has RT-PCR confirmed SVD
• OR Infants born to mothers who have a positive RT-PCR results for SUDV within 10 days of birth or with a documented positive RT-PCR test for SUDV in >10 days but with ongoing symptoms of SVD
• women of who are of child-bearing age must use highly effective contraception for 90 days after receiving the medication
• any medical condition that, in the opinion of the physician, would unreasonably increase risk of side effects (study staff will assess)
Seasonal influenza vaccine high dose boosting in solid organ transplant recipients
We know that patients who have undergone a solid organ transplant are at higher risk for severe influenza infections and may not develop a robust antibody response to a single dose of the influenza vaccine. The purpose of this study is to better understand the body’s response to two doses of the high-dose influenza vaccine compared to one dose during an influenza season.
• at least 18 years old
• history of a solid organ transplant (liver, lung, heart, kidney, pancreas) at least 1 year before starting the study
• women who are pregnant
• received ATG or carfilzomib in the past 3 months
• received rituximab or basiliximab in the past 3 months
• prednisone dose is greater than 20mg/ day
• history of a severe allergy to influenza vaccine (e.g., Guillain-Barré syndrome, anaphylaxis, or angioedema)
• have received the influenza vaccine for the current season
A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study) (ReSPECT)
One type of infection that is possible after bone marrow transplant is called an invasive fungal disease (IFD), a type of fungal infection that has the ability to spread throughout the body. In this study, rezafungin will be compared with the currently approved drugs for the prevention of IFD. The currently approved drugs are referred to as the standard antimicrobial regimen (SAR) which is posaconazole or fluconazole. We want to learn if rezafungin is safe and tolerable, if it is effective in preventing IFD compared to the standard treatment and to find out how much rezafungin is in blood over time after study drug has been given.
• receiving a human leukocyte antigen (HLA) matched or unmatched peripheral bone marrow transplant (BMT)
• diagnosis of one of the following underlying diseases: acute myeloid leukemia (AML), acute lymphoblastic leukemia, acute undifferentiated leukemia, acute biphenotypic leukemia, or chronic myelogenous leukemia
• women and men must agree to use birth control for 120 days after last dose of study drug
• see link to clinicaltrials.gov for completed inclusion and exclusion criteria
• diagnosis of AML not in remission
• significant heart or lung disease
• previous allogeneic BMT
• ataxia, neuropathy or tremors; or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease or Huntington's disease)