Search Results Within Category "Infectious Diseases"
An interventional efficacy and safety Phase 3 double-blind 2-arm study to investigate IV followed by oral fosmanogepix compared with IV caspofungin followed by oral fluconazole in adult participants with candidemia and/or invasive candidiasis.
The purpose of this study is to compare effects of the study drug fosmanogepix with already-approved drugs caspofungin and fluconazole to find out if fosmanogepix is safe and effective in treating patients with candidemia and/or invasive candidiasis.
• diagnosis of candidemia and/or invasive candidiasis
• see link to cliinicaltrials.gov for complete Inclusion criteria
• require hemodialysis, peritoneal dialysis, or hemofiltration
• received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
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)
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)
A randomized, double-blind, placebo- controlled study of LMN-201 for prevention of C. difficile infection recurrence (RePreve)
This study is recruiting people who have developed an infection of the lower intestine (the colon) by bacteria called Clostridioides difficile (abbreviated C. difficile or C. diff). The standard treatment for this infection is with antibiotics, but in some people, the infection keeps coming back. The purpose of this research is to test whether an investigational drug can prevent a return of the infection. We want to make sure LMN-201 is safe when used as part of standard of care for C. diff, and we want to see if we can improve treatment and reduce re-infection.
• diagnosis of Clostridioides Difficile Infection (CDI) defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency and a positive stool C. difficile toxin B immunoassay and no other likely explanation for diarrhea
• able to take oral medication and willing to adhere to the study medication
• have access to a mobile smartphone
• women and men of reproductive potential must use of highly effective contraception during study participation and for an additional 4 weeks after the end of study drug administration
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• violent diarrhea from C. difficile colitis
• Underlying gastrointestinal disorder characterized by diarrhea such as chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, etc.
• women who are pregnant, trying to get pregnant or breast feeding
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
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.
• healthy volunteers without systemic or respiratory disease
• non-smokers or former smokers who quit more than 6 months ago (including marijuana)
• ages 18-50
• preferred but not required: have lived in countries in Africa, Latino America or South East Asia
• preferred but not required: history of positive tuberculosis (TB) skin or blood test
• recent illness, bleeding disorders, or a history of heart, lung, or systemic disease
• weakened immune system or use of immunosuppressant medication
• use of inhaled substances in the past six months or history of heavy smoking
• allergy or prior adverse reaction to lidocaine, midazolam, or fentanyl
• pregnancy
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)
Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary symptoms of Long COVID (REVERSE-LC) (REVERSE-LC)
The purpose of this study is to understand if a drug called baricitinib can help with thinking and memory problems after COVID-19 infection for people suffering with Long COVID. Some people have thinking and memory problems along with possible difficulty breathing, a racing heart, dizziness, and/or fatigue after COVID-19 called Long COVID. This includes things like having a hard time remembering people’s names, managing money, or keeping a job. For some patients, these issues may last several years. We still do not understand why these problems happen and why they last longer in some people. This study will look at the changes in brain function, heart function, and daily activities after taking baricitinib or placebo for people who experience Long COVID.
• documented COVID infection 6 or more months prior
• clinical evidence of Long COVID such as fatigue, chills, post-exertional malaise, trouble with memory/concentration ("brain fog"), headache, dysautonomia/postural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance, chest pain, palpitations, shortness of breath, cough, fainting spells, muscle aches, joint pain, nausea, diarrhea
• symptoms must have started after January 2020 and be present for at least 6 months prior starting the study
• symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome
• see link to clinicaltrials.gov for complete inclusion criteria
• severe cognitive, physical, or psychological disability preventing participation
• currently pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the study
• admission to an ICU for treatment of acute COVID-19 infection
• cancer diagnosis in the past 5 years
• see link to clinicaltrials.gov for complete 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
An interventional Phase 3, open-label, two-cohort study to investigate the efficacy and safety of fosmanogepix in adult patients with invasive mold infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds
The purpose of this study is to compare the effects of the study drug fosmanogepix with that of other currently approved treatments to find out if fosmanogepix is safe and effective in treating participants with invasive mold infections. Participants will be assigned to one of two groups depending on the study treatment already received for the current mold infection. Participation in this study will be for a maximum of 8 months.
• diagnosis of proven or probable Invasive mold infection
• see link to clinicaltrials.gov for complete Inclusion criteria
• need or anticipated need for hemodialysis, peritoneal dialysis, or hemofiltration
• moderate or severe liver disease
• known human immunodeficiency virus infection
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Neurodevelopmental Outcomes for CMV Infections Identified by Newborn Screening
This research study is about early development in children diagnosed with congenital cytomegalovirus infection (cCMV), identified by newborn screening that has been confirmed with a follow-up test. Study visits, when the child is 12, 24 and 36 months of age, will include questionnaires, direct assessment of child and interviews with parent(s). A brain MRI will also be completed at about 12 months. Parents will receive a report summarizing a child’s developmental, language, and behavioral assessments, reported as within normal ranges or if clinical follow-up is recommended.
• less than 14 months old
• tested positive for congenital cytomegalovirus (also called cCMV or CMV) on the newborn heel / blood spot screening test
• parent/guardian is able to complete study visits, interviews and questionnaires in English
• certain medical conditions that study staff will screen for during the process of joining the study