Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Targeted amplicon sequencing of sputum [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
- Sputum microbiology [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)
- Change in lung function [At initiation of IV antibiotic treatment and after one week of IV antibiotic treatment]
Change in lung function as measured by FEV1, % predicted.
Secondary Outcome Measures
- Changes in hospitalizations [12 months prior to enrollment to 12 months after enrollment]
Changes in frequency/number of hospitalizations for treatment of CF pulmonary exacerbation
- Antimicrobial regimens [Throughout course of hospitalization, on average 14 days]
Type/total number of IV antibiotic doses delivered
Eligibility Criteria
Criteria
Inclusion Criteria:
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CF patients 18 years or older who are hospitalized for IV treatment of an acute PEx
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Chronically infected with Pseudomonas aeruginosa and/or Staphylococcus aureus
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Can produce sputum
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Can provide written consent
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Willing to comply with study procedure
Exclusion Criteria:
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Subjects who are not colonized with Pseudomonas aeruginosa and/or Staphylococcus aureus
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Jewish Health | Denver | Colorado | United States | 80206 |
Sponsors and Collaborators
- National Jewish Health
- Cystic Fibrosis Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAAVED19A0