Immune Profiles in CF Fungal Infection

Status: Completed

Location: See location...

Study Type: Observational

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 8

Maximum Age: 25

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• 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.

Locations

United States

Colorado

Childrens Hospital Colorado

Highlands Ranch

Time Frame

Start Date: 2021-02-10

Completion Date: 2023-10-30

Participants

Target number of participants: 24

Treatments

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.

Related Therapeutic Areas

Allergic Bronchopulmonary Aspergillosis

Cystic Fibrosis

Aspergillosis

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