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Search Results Within Category "Infectious Diseases"

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15 Study Matches

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.

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021347
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Inclusion Criteria:

• 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
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)
Infectious Diseases
BMT, Bone Marrow Transplant, Candidemia, Fungal Infection, Infection, Infectious Disease, Mycoses
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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.

Beth Thielen
Not specified
This study is also accepting healthy volunteers
STUDY00019522
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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)
Community Health, Infectious Diseases, Respiratory System
germs, infection, respiratory illness, RSV, virus
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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.

Michael Puskarich
18 years and over
This study is NOT accepting healthy volunteers
SITE00001869
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Inclusion Criteria:

• Age 65 or older
• Primary diagnosis of acute infection
• Expected length of hospital stay at least 48 hours
Exclusion Criteria:

• No acute infection
• Known hypersensitivity or allergy to Fisetin
• Not admitted to hospital
• Enrolled in another Sepsis clinical trial
Infectious Diseases
Fisetin, Sepsis
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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.

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00022202
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Inclusion Criteria:

• 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
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
Infectious Diseases
C-Diff, CDI, Clostridioides Difficile Infection
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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.

Jo-Anne Young, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00020605
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Inclusion Criteria:

• 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
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
Rare Diseases, Infectious Diseases
Clinics and Surgery Center (CSC), Herpes, Herpes Simplex Virus, HSV Infection
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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.

Jo-Anne Young, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00022419
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Inclusion Criteria:

• 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
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
Rare Diseases, Infectious Diseases
C. Diff Infection, CDI, Clostridium Difficile, Clostridium Difficile Infections, Diarrhea
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A Phase 1 Pharmacokinetic and Safety Assessment of Oral Letermovir in Infants with Symptomatic Congenital Cytomegalovirus Disease

The purpose of this study is to determine the dose of a new medication being studied for babies who are exposed to cytomegalovirus during birth. This is called congenital cytomegalovirus (cCMV). Cytomegalovirus is the leading cause of hearing loss and the leading viral cause of developmental delays in children. If a baby participates in this study, in addition to the study medication, he/she will still receive the current best treatment for cCMV, which is oral Valganciclovir.

Mark Schleiss
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00021875
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Inclusion Criteria:

• age at enrollment is 90 days or younger
• gestational age at birth is 32 weeks or greater
• diagnosis or symptomatic congenital CMV (cytomegalovirus)
• minimum weight of 2.6kg (5 lb, 12 oz.)
Exclusion Criteria:

• receiving other investigation drug
• high bilirubin or ALT
Infectious Diseases
CMV, congenital, cytomegalovirus, treatment, valgancyclovir
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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.

Mark Schleiss
Up to 18 years old
This study is also accepting healthy volunteers
SITE00001871
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Children's Health, Infectious Diseases
CMV, cytomegalovirus, vaccine
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A Phase 2 Randomized, Placebo-controlled Study of the Safety and Efficacy of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

We are running this research study to learn about Obeldesivir (ODV) for people with RSV infection who have not been hospitalized for treatment. People in the study will take ODV or placebo (an inactive substance) for up to 5 days.

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00023194
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Inclusion Criteria:

• at least 1 of the following risk factors for severe RSV disease: at least 60 years old, moderate or severe COPD, asthma with at least one exacerbation during the proceeding year, significant lung or heart disease
• positive test for RSV in the last 3 days
• if age is the only risk factor, must not have received the RSV vaccine
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• in the hospital, or expect to need hospitalization
• previous infection and/or hospitalization for RSV during the current respiratory virus season
• positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the past week
• history of cystic fibrosis
• require dialysis, known history of moderate or severe renal impairment
• women who are pregnant
Infectious Diseases
RSV infection
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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.

Monica Campo Patino
18 years and over
This study is also accepting healthy volunteers
STUDY00016947
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Immune Diseases, Infectious Diseases, Respiratory System
blood, blood donation, blood draw, bronchoscopy, Healthy Volunteer, TB, TLC, Tuberculosis
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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).

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017568
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Inclusion Criteria:

• diagnosis of invasive pulmonary aspergillosis that hasn't responded to treatment
Exclusion Criteria:

• surgical or medical condition that makes participation difficult or potentially unsafe
• require care in an intensive care unit
Breathing, Lung & Sleep Health, Infectious Diseases
Clinics and Surgery Center (CSC), antifungal therapy, aspergillosis, fungal infection, lung infection, pulmonary aspergillosis
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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.

Mahsa Abassi
18 years and over
This study is NOT accepting healthy volunteers
SITE00001781
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Inclusion Criteria:

• 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
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
Infectious Diseases, Respiratory System
Clinics and Surgery Center (CSC), COVID, hospitalized, inpatient, pneumonia, respiratory infection

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.

Susan Kline, MD
Not specified
This study is NOT accepting healthy volunteers
SITE00001888
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Inclusion Criteria:

• 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
Exclusion Criteria:

• any medical condition that, in the opinion of the physician, would unreasonably increase risk of side effects (study staff will assess)
Infectious Diseases, Rare Diseases
Sudan Virus Disease, SVD
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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.

Lauren Fontana
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017687
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Inclusion Criteria:

• at least 18 years old
• history of a solid organ transplant (liver, lung, heart, kidney, pancreas) at least 1 year before starting the study
Exclusion Criteria:

• 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
Infectious Diseases
Clinics and Surgery Center (CSC), influenza, influenza vaccine, Solid organ transplant
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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.

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019092
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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)
Infectious Diseases, Respiratory System
Aspergillosis, IA, Invasive Aspergillosis (IA), Lung Infection
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