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Immune Profiles in CF Fungal Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04476758
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study is investigating the role of allergic (Th2) inflammation in patients with Cystic Fibrosis (CF) and history of fungal infection and/or Allergic Bronchopulmonary Aspergillosis. Little is known about fungal infection in CF and conflicting results exist on whether this results in worse lung function over time. There is concern that persistent fungal infection can result in worse clinical outcome measures in patients with CF. Also, it is unclear how ABPA develops, but may be related to the amount of fungus a patient with CF is infected with. This study looks at inflammatory patterns and allergic responses to fungal elements to help identify biomarkers and signs of allergic disease in fungally infected patients with CF.

Condition or disease
Cystic Fibrosis Fungal Infection Allergic Bronchopulmonary Aspergillosis

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Immune Profiles in CF Fungal Infection
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022


Group/Cohort
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).
Control Group
Have never previously isolated fungus from sputum, BAL, or OP swab (N=10).
ABPA Group

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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
Sputum and serum from subjects


Information from the National Library of Medicine

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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
Study Population
Pediatric to young adult patients with CF followed at Children's Hospital Colorado. Patients must meet inclusion/exclusion criteria and fit into one of the three groups described.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • History of Burkholderia sp. or Non-tuberculosis Mycobacterium
  • Comorbid or health contraindication to induced sputum treatment or blood draw

Information from the National Library of Medicine

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


Contacts
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Contact: Thomas S Poore, MD 7207776181 spencer.poore@childrenscolorado.org
Contact: Edith Zemanick, MD 7207776181 edith.zemanick@childrenscolorado.org

Locations
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United States, Colorado
Childrens Hospital Colorado Recruiting
Highlands Ranch, Colorado, United States, 80310
Contact: Thomas Poore, MD    706-831-5052    tspoore@gmail.com   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Thomas S Poore, MD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Informed Consent Form  [PDF] June 10, 2020

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04476758    
Other Study ID Numbers: 20-0099
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Fungal Infection
Th2 Inflammation
Cystic Fibrosis
Fungal allergy
Allergic Bronchopulmonary Aspergillosis
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Mycoses
Aspergillosis
Pulmonary Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases, Fungal
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases