Host and Bacterial Mechanisms During Cystic Fibrosis Pulmonary Exacerbations

  • STATUS
    Recruiting
  • End date
    Dec 11, 2026
  • participants needed
    100
  • sponsor
    National Jewish Health
Updated on 11 September 2021
antibiotic therapy
antibiotics
pulmonary function test
fibrosis
pulmonary infection

Summary

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.

Details
Condition Pancreatic disorder, Pancreatic Disorders, Lung Disease, Pulmonary Disease, Cystic Fibrosis
Clinical Study IdentifierNCT04354038
SponsorNational Jewish Health
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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