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Search Results Within Category "Allergy"
4 Study Matches
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing (DACAT)
Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.
Call 214-648-5005
studyfinder@utsouthwestern.edu, DEBORAH.GONZALES@UTSouthwestern.edu
David Khan
ALL
18 Years to 70 Years old
PHASE2
NCT06406114
STU-2024-1178
Inclusion Criteria:
• Age 18-70 years old.
• Reaction history consistent with a potential immediate hypersensitivity reaction (pruritus, urticaria, erythema, angioedema, bronchospasm, wheezing, shortness of breath, anaphylaxis, or hypotension) to cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime.
• English speaking or non-English speaking with translation services available.
Exclusion Criteria:
• Severe concomitant medical condition (e.g., unstable coronary artery disease, congestive heart failure, severe chronic obstructive pulmonary disease, poorly controlled asthma, chronic renal failure, cirrhosis, or end-stage liver disease.)
• History of Clostridioides difficile infection
• Chronic spontaneous urticaria or systemic mastocytosis
• Incident reaction required cardiopulmonary resuscitation
• Reaction to 2 or more cephalosporin antibiotics
• Active infection or antibiotic treatment within 7 days
• Treatment with systemic antihistamines or corticosteroids within 7 days
• Treatment with omalizumab or dupilumab within 60 days
• Significant immunosuppression
• Treatment with a beta-blocker or ACE inhibitor within 7 days
• Use of investigational drugs within 60 days of participation
• Anaphylaxis in the last 30 days
• Penicillin anaphylaxis within the past year confirmed with positive penicillin skin tests
• Prison or jail inmates, pregnant women, severe cognitive impairment
• Current, diagnosed, mental illness or current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
• Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
• Inability or unwillingness of a participant to give written informed consent or comply with study protocol
DRUG: Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing, DRUG: Culprit cephalosporin (cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime) double-blind placebo-controlled drug challenge, DRUG: Similar cephalosporin (cefepime, ceftriaxone, cefaclor, cephalexin, cefixime, or cefdinir) antibiotic double-blind placebo-controlled drug challenge, DRUG: Dissimilar cephalosporin (ceftriaxone or cefazolin) antibiotic double-blind placebo-controlled drug challenge, DRUG: Amoxicillin double-blind placebo-controlled drug challenge
Drug Allergy, Cephalosporin Allergy, Drug Hypersensitivity, Antibiotic Allergy, Beta Lactam Adverse Reaction, Drug-Induced Anaphylaxis, Cephalosporin Reaction
Allergy, Antibiotic, Cephalosporin, Penicillin, Beta-lactam, Drug challenge, Skin testing, Adverse reaction, Anaphylaxis, Perioperative anaphylaxis
UT Southwestern
Escitalopram in Asthma Patients With Frequent Exacerbation
Antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), such as escitalopram are widely used for mood and anxiety disorders. However, they have also been explored, with promising findings, for a variety of disorders outside of psychiatry. Clinical studies of SSRIs in depressed people with asthma were associated with decreased asthma exacerbations and improvement in asthma control. In this study, the number of asthma exacerbations will be assessed as the primary outcome measure, in patients using escitalopram vs. placebo.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Reagan.Volzer@UTSouthwestern.edu
Edson Brown
ALL
18 Years to 65 Years old
PHASE2
NCT06216535
STU-2023-0494
Inclusion Criteria:
* Moderate to severe persistent asthma
* Treatment with medium to high dose ICS and LABA therapy
* Three or more severe asthma exacerbations (requiring ≥ 3 days of systemic corticosteroids) in the past year
* Age 18-65 years old, male or female sex, English or Spanish speaking
* Participants will be required to be clinically stable with no recent exacerbations, infections or changes in asthma controller therapy for at least 4 weeks before study entry
* Biologic therapy for asthma (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) will be allowed if started at least 6 months prior to randomization
Exclusion Criteria:
* Current substance use disorder and/or current tobacco use or greater than 10 pack-years lifetime use
* A current MDD episode as well as bipolar disorder, schizophrenia, or schizoaffective disorder
* Vulnerable populations including intellectual disability or other severe cognitive impairment, inmates, pregnant or nursing women or women of childbearing age who will not use UT Southwestern IRB-approved methods of birth control or abstinence during the study
* Currently taking an antidepressant (antidepressants that are not SSRIs nor SNRIs prescribed for an indication other than depression at subtherapeutic doses are acceptable)
* High risk for suicide defined as \> 1 past suicide attempts or any attempt within the past 12 months
* Severe or life-threatening medical illness that would make completion of study unlikely or clinically significant laboratory or ECG findings at baseline DRUG: Escitalopram, DRUG: Placebo
Asthma
Escitalopram, SSRI, Adults
UT Southwestern; Parkland Health & Hospital System
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age (VITESSE)
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month treatment period.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Priscilla.Arancivia@UTSouthwestern.edu
Christopher Parrish
All
4 Years to 7 Years old
Phase 3
NCT05741476
STU-2023-0051
Key
• Aged 4 through 7 years at Visit 1 (screening).
• Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
• Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1.
• An ED of ≤100 mg peanut protein at screening DBPCFC. Key
• Severe generalized dermatologic disease involving the application area (interscapular region)
• Uncontrolled persistent asthma.
• Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT).
• Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
Inclusion Criteria:
• Aged 4 through 7 years at Visit 1 (screening).
• Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
• Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1.
• An ED of ≤100 mg peanut protein at screening DBPCFC. Key
Exclusion Criteria:
• Severe generalized dermatologic disease involving the application area (interscapular region)
• Uncontrolled persistent asthma.
• Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT).
• Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
Drug: DBV712, Other: Placebo
Allergy, Peanut, Other
Peanut Hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy
Children’s Health
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Aruna.Ayalasomayajula@UTSouthwestern.edu
Mia Maamari
ALL
0 Years to 20 Years old
NCT04278404
STU-2021-0176
Inclusion Criteria:
• Participant is \< 21 years of age
• Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
• (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:
• Participant has a known pregnancy Below exclusion criteria apply only to: Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)
• Has had intermittent dialysis within previous 24 hours
• Has had a kidney transplant within previous 30 days
• Has had a liver transplant within previous 1 year
• Has had a stem cell transplant within previous 1 year
• Has had therapeutic hypothermia within previous 24 hours
• Has had plasmapheresis within the previous 24 hours
• Has a Ventricular Assist Device
• Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
DRUG: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis, Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
Children’s Health