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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04341532
• Other study ID #: SAAVED19A0
• Status: Recruiting
• Start date: February 20, 2020
• Est. completion date: December 2025

Study information

• Verified date: September 2022
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
Primary	Sputum microbiology	Traditional sputum microbiology results; this may include quantitative culture data for each pathogen, antimicrobial susceptibilities, and minimum inhibitory concentration (MIC)	Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
Primary	Change in lung function	Change in lung function as measured by FEV1, % predicted.	At initiation of IV antibiotic treatment and after one week of IV antibiotic treatment
Secondary	Changes in hospitalizations	Changes in frequency/number of hospitalizations for treatment of CF pulmonary exacerbation	12 months prior to enrollment to 12 months after enrollment
Secondary	Antimicrobial regimens	Type/total number of IV antibiotic doses delivered	Throughout course of hospitalization, on average 14 days