National Jewish Health
Denver, Colorado, 80206, United States
NCT Number: NCT04341532
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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Notify Me18 year and older
All sexes
Observational
Denver, Colorado, 80206, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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)
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.
Time frame: 12 months prior to enrollment to 12 months after enrollment
Changes in frequency/number of hospitalizations for treatment of CF pulmonary exacerbation
Time frame: Throughout course of hospitalization, on average 14 days
Type/total number of IV antibiotic doses delivered
National Jewish Health
Other
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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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