Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Host and Bacterial Mechanisms During Cystic Fibrosis Pulmonary Exacerbations

NCT04354038

Cystic Fibrosis

ACTIVE_NOT_RECRUITING

Outpatient Antibiotic Treatment for a Cystic Fibrosis Pulmonary Exacerbation

NCT02480270

Cystic Fibrosis

COMPLETED

The Infective Pulmonary Exacerbations in Cystic Fibrosis - an Ecological Perspective

NCT01306279

Cystic Fibrosis

COMPLETED

Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis

NCT02372383

Cystic Fibrosis

COMPLETED NA

Parameters to Assess Response to Intra-Venous Antibiotic Treatment for Pulmonary Exacerbations in Cystic Fibrosis

NCT04016571

Cystic Fibrosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No