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

NCT04341532 | Completed

• 1 other identifier: SAAVED19A0
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Changes in hospitalizations

  12 months prior to enrollment to 12 months after enrollment

• Antimicrobial regimens

  Throughout course of hospitalization, on average 14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Jewish Health: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 10, 2020
• Study Start: February 20, 2020
• Primary Completion: July 26, 2023
• Study Completion: August 9, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)