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OpenTrials
Completed

NCT Number: NCT04341532

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Targeted amplicon sequencing of sputum

    Time frame: Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation

    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

  2. Sputum microbiology

    Time frame: Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation

    Traditional sputum microbiology results; this may include quantitative culture data for each pathogen, antimicrobial susceptibilities, and minimum inhibitory concentration (MIC)

  3. Change in lung function

    Time frame: At initiation of IV antibiotic treatment and after one week of IV antibiotic treatment

    Change in lung function as measured by FEV1, % predicted.

Secondary outcomes

  1. Changes in hospitalizations

    Time frame: 12 months prior to enrollment to 12 months after enrollment

    Changes in frequency/number of hospitalizations for treatment of CF pulmonary exacerbation

  2. Antimicrobial regimens

    Time frame: Throughout course of hospitalization, on average 14 days

    Type/total number of IV antibiotic doses delivered

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Apr 10, 2020
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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