Host and Bacterial Mechanisms During Cystic Fibrosis Pulmonary Exacerbations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-07

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No