Immune Profiles in CF Fungal Infection

NCT04476758 | Completed

• 2 other identifiers: 20-0099POORE20D0
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Fungal Infection; Allergic Bronchopulmonary Aspergillosis

Keywords

Fungal Infection; Th2 Inflammation; Cystic Fibrosis; Fungal allergy; Allergic Bronchopulmonary Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Difference in Th2 Sputum Markers

  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.

  Day 1

Secondary Outcomes (1)

• Other markers of fungal inflammation and allergic reaction in patients with CF

  Day 1

Other Outcomes (1)

• Biobanking of specimens

  Day 1

Study Arms (3)

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.

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Childrens Hospital Colorado

Highlands Ranch, Colorado, 80310, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum and serum from subjects

MeSH Terms

Conditions

Cystic Fibrosis; Mycoses; Aspergillosis, Allergic Bronchopulmonary

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bacterial Infections and Mycoses; Infections; Pulmonary Aspergillosis; Aspergillosis; Lung Diseases, Fungal; Respiratory Tract Infections; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Thomas S Poore, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 20, 2020
• Study Start: February 10, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

US (1)