Clinical trial NCT04341532: Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations
Official title: Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2020-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Targeted amplicon sequencing of sputum
timeFrame: Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
measure: Sputum microbiology
timeFrame: Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
measure: Change in lung function
timeFrame: At initiation of IV antibiotic treatment and after one week of IV antibiotic treatment
Secondary outcomes:
measure: Changes in hospitalizations
timeFrame: 12 months prior to enrollment to 12 months after enrollment
measure: Antimicrobial regimens
timeFrame: Throughout course of hospitalization, on average 14 days
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References: