Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations

Pulmonary exacerbations (PEx) are key events that lead to a decline in health status among CF patients, with many never recovering to baseline health. With the advancement of new CFTR modulators and other therapies increasing the lifespan of those living with CF, it will become increasingly important to have better strategies to manage PEx in order to have better outcomes following treatment. PEx treatment decisions will need to take into consideration the increasing frequency of antimicrobial resistance bacteria and the need to treat multiple types of bacteria at once. The purpose of this study is to analyze sputum samples from CF subjects at the time of PEx in order to identify markers of antimicrobial resistant bacteria and see how those relate to treatment responses. CF patients will be recruited from patients followed by the Adult CF Program at National Jewish Health. Within 48 hours of admission to the hospital for treatment of a PEx, subjects will be enrolled and sputum will be collected. The sputum will be processed and analyzed for the presence of antimicrobial resistant bacteria. These results will be compared to clinical data, such as spirometry and frequency of hospitalizations.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

An eligible subject will be a current patient of the Colorado Adult CF Clinic who is being hospitalized at the onset of IV treatment for a pulmonary exacerbation, as diagnosed by a clinic physician, and who is chronically infected with Pseudomonas aeruginosa and/or Staphylococcus aureus.

Description

Inclusion Criteria:

• CF patients 18 years or older who are hospitalized for IV treatment of an acute PEx
• Chronically infected with Pseudomonas aeruginosa and/or Staphylococcus aureus
• Can produce sputum
• Can provide written consent
• Willing to comply with study procedure

Exclusion Criteria:

• Subjects who are not colonized with Pseudomonas aeruginosa and/or Staphylococcus aureus
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Targeted amplicon sequencing of sputum	Results from CF specific amplicon panel; this may include number and identity of bacterial species, presence or absence of AMR genes, frequencies of strain types, and AMR genes per total bacteria	Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
Sputum microbiology	Traditional sputum microbiology results; this may include quantitative culture data for each pathogen, antimicrobial susceptibilities, and minimum inhibitory concentration (MIC)	Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
Change in lung function	Change in lung function as measured by FEV1, % predicted.	At initiation of IV antibiotic treatment and after one week of IV antibiotic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in hospitalizations	Changes in frequency/number of hospitalizations for treatment of CF pulmonary exacerbation	12 months prior to enrollment to 12 months after enrollment
Antimicrobial regimens	Type/total number of IV antibiotic doses delivered	Throughout course of hospitalization, on average 14 days

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Cystic Fibrosis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): August 9, 2024

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cystic Fibrosis
• Other Study ID Numbers: SAAVED19A0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No