Cystic FibrosisNCT04341532
Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations
An observational study of Cystic Fibrosis, run by National Jewish Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 9 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted amplicon sequencing of sputum
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
Measured: Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
Sputum microbiology
Traditional sputum microbiology results; this may include quantitative culture data for each pathogen, antimicrobial susceptibilities, and minimum inhibitory concentration (MIC)
Measured: Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
Change in lung function
Change in lung function as measured by FEV1, % predicted.
Measured: At initiation of IV antibiotic treatment and after one week of IV antibiotic treatment
Secondary outcomes (2)
Changes in hospitalizations
Changes in frequency/number of hospitalizations for treatment of CF pulmonary exacerbation
Measured: 12 months prior to enrollment to 12 months after enrollment
Antimicrobial regimens
Type/total number of IV antibiotic doses delivered
Measured: Throughout course of hospitalization, on average 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start20 Feb 2020
- Primary completion26 Jul 2023
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341532
- Sponsor's protocol ID
- SAAVED19A0
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations
- ClinicalTrials.gov ID
- NCT04341532
- Acronym / sponsor ID
- SAAVED19A0
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
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.
2 secondary outcomes
Changes in hospitalizations
Time frame: 12 months prior to enrollment to 12 months after enrollment
Antimicrobial regimens
Time frame: Throughout course of hospitalization, on average 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted amplicon sequencing of sputum (time frame: Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.