Immune Profiles in CF Fungal Infection
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|ClinicalTrials.gov Identifier: NCT04476758|
Recruitment Status : Enrolling by invitation
First Posted : July 20, 2020
Last Update Posted : November 2, 2022
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|Condition or disease|
|Cystic Fibrosis Fungal Infection Allergic Bronchopulmonary Aspergillosis|
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Immune Profiles in CF Fungal Infection|
|Actual Study Start Date :||February 10, 2021|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||October 31, 2023|
Fungal Infection Group
Have had a fungal species isolated from sputum and/or BAL culture on >= 2 separate occasions in the 18 months preceding study visit and do not have a diagnosis of ABPA (N=10).
Have never previously isolated fungus from sputum, BAL, or OP swab (N=10).
Previous diagnosis of ABPA as defined by CFF guidelines, regardless of the amount of fungal infection or history thereof.
• ABPA Minimum diagnostic criteria per CFF: Acute or subacute deterioration, total serum IgE > 500 IU per mL, immediate cutaneous reactivity to Aspergillus or in vitro IgE antibody to A. fumigatus, and either a new or recent chest imaging change that has not responded to antibiotics and standard physiotherapy OR precipitin to A. fumigatus or IgG antibody to A. fumigatus1 (N=5). Culture positive sputum is not required for ABPA diagnosis and is not taken into account for the diagnosis per CFF guidelines.
- Difference in Th2 Sputum Markers [ Time Frame: Day 1 ]Difference in sputum Th2 biomarkers (ECP, IL4, IL5, IL10, IL13, and eosinophil count) in patients with CF with fungal infection with expected elevation of sputum Th2 biomarkers in patients with CF and ABPA compared to those without fungal infection and without ABPA.
- Other markers of fungal inflammation and allergic reaction in patients with CF [ Time Frame: Day 1 ]
- Serum Th2 biomarkers in patients with fungal infection and ABPA (Table 3).
- Serum Th1 biomarkers in patients with fungal infection and ABPA (Table 3).
- Serum sensitization markers to fungal allergens in patients with fungal infection and ABPA (Table 4).
- Baseline and historic lung function, historical comorbid diagnoses and BMI measurements in patients with fungal infection and ABPA.
- Environmental factors that are possibly related to fungal infection and ABPA in patients with CF.
- Immune profile: A profile of each group will be based upon their findings of each set of biomarkers: Th1, Th2, mold allergy panel, and systemic markers of inflammation. Based upon findings in each of these categories (elevated, depressed), we will be able to formulate a profile based upon the type of marker/inflammatory pathway.
- Biobanking of specimens [ Time Frame: Day 1 ]Banking of both sputum and serum to potentially utilize microbiome and transcriptome techniques for further immunotyping and infection characterization.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||8 Years to 25 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Sampling Method:||Non-Probability Sample|
- Diagnosis of CF per CFF guidelines and followed at Children's Hospital Colorado (CHCO) CF Center
- Meets criteria of only one fungal group (described below)
- Clinical stability without any change acute antibiotic regimen in the past 14 days
- Clinical stability without any use for acute NSAID or oral steroids in past 14 days
- Individuals with other co-morbid conditions related to and unrelated to CF, including but not limited to CF related diabetes, CF related liver disease, asthma, etc.
- History of Burkholderia sp. or Non-tuberculosis Mycobacterium
- Comorbid or health contraindication to induced sputum treatment or blood draw
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476758
|United States, Colorado|
|Childrens Hospital Colorado|
|Highlands Ranch, Colorado, United States, 80310|
|Principal Investigator:||Thomas S Poore, MD||University of Colorado, Denver|
Documents provided by Thomas Spencer Poore, University of Alabama at Birmingham:
|Responsible Party:||Thomas Spencer Poore, Assistant Professor, University of Alabama at Birmingham|
|Other Study ID Numbers:||
|First Posted:||July 20, 2020 Key Record Dates|
|Last Update Posted:||November 2, 2022|
|Last Verified:||October 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Allergic Bronchopulmonary Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bacterial Infections and Mycoses
Lung Diseases, Fungal
Respiratory Tract Infections
Immune System Diseases