Host and Bacterial Mechanisms During Cystic Fibrosis Pulmonary Exacerbations

National Jewish Health

Status: Active, not recruiting

Conditions: Cystic Fibrosis

Study type: Observational

Funder types: Other

Identifiers

NCT04354038

SAAVED19G0

Details and patient eligibility

About

Cystic fibrosis pulmonary exacerbations (CF PEx) vary greatly in their severity, their pathogens, and their treatment responses. A failure to return to baseline lung function after treatment may be due to persistent infection or chronic inflammation or both. This constant infection and inflammation are believed to be tightly connected, making it difficult to know the exact reason why some patients fail to respond to treatment. The purpose of this study is to evaluate both infection and inflammation during CF PEx to allow for more personalized approaches to improve lung function responses and better CF PEx outcomes. Subjects will be asked to be in the study if they have CF, are 18 years of age or older, and are starting on IV antibiotics due to worsening lung infection. Subjects will stay in the study for up to 5 years, with visits occurring once a year if hospitalized for a CF PEx. Each visit will have blood, sputum, and urine collected and analyzed for changes in expression of certain genes and proteins. These changes may relate to improvements felt by people living with CF and determine what treatments are most helpful.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CF patients 18 years or older
• hospitalized for IV treatment of an acute pulmonary exacerbation
• not on investigational drugs
• who can provide written consent and are willing to comply with study procedure

Exclusion criteria

• the presence of a condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the patient or the quality of the data.