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NCT04341532 · ClinicalTrials.gov registry record
Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations
A clinical trial, sponsored by National Jewish Health.
- Completed
- Registry status
- 83
- Enrollment target
NCT04341532: Completed study, sponsored by National Jewish Health.
NCT04341532 is a clinical trial that has completed, run by National Jewish Health. The registered enrollment target is 83 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04341532 has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- 83 participants
- Enrollment target
Study 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.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2020-02-20 |
| Est. Completion | 2024-08-09 |
What the finished NCT04341532 record still lists
NCT04341532 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 83 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04341532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04341532 about?
NCT04341532 is a clinical study titled "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 importan...
What is the current status of trial NCT04341532?
This trial is currently completed. The enrollment target is 83 participants. The study started on 2020-02-20. Estimated completion is 2024-08-09.
Who is sponsoring clinical trial NCT04341532?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
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