A Study to Investigate Bacterial Load, Patient Characteristics and Exploratory Biomarkers in Adult Patients with Cystic Fibrosis or Non-Cystic Fibrosis Bronchiectasis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-001735
Sponsor Protocol Number: NOPRODCYS0001
About this study
The purpose of this study is to investigate Pseudomonas Aeruginosa and Staphylococcus Aureus bacterial
load, patient characteristics and exploratory biomarkers in adult patients with Cystic Fibrosis or
Non-Cystic Fibrosis Bronchiectasis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Aged 18 years or older at the time of consent to participate in the study.
- Clinical confirmed diagnosis of CF or NCFB per clinical records and guidelines of the CF Foundation or European Respiratory Society (ERS), respectively, for at least 12 months.
- Positive sputum culture for PA or SA (not both) at screening.
- Forced expiratory volume in 1 second (FEV1) ≥ 50% at screening.
For participants with NCFB:
- Not taking chronic inhaled and/or oral antibiotics at screening.
For participants with CF:
- Taking no or only one chronic inhaled antibiotic on alternating months at screening.
- CF patients taking CFTR channel modulators are permitted in the study.
Exclusion Criteria:
- Currently participating in vaccine studies or interventional studies for respiratory infections/diseases.
- Has been taking systemic antibiotics within 30 days prior to screening.
- Clinically significant and unstable cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, endocrinologic, oncologic, ophthalmologic, musculoskeletal, psychiatric or any other uncontrolled medical illness at screening.
- Underwent lung transplantation.
- Positive sputum culture for PA or SA and for other pathogens (e.g., Burkholderia spp., H. influenzae, S. pneumoniae, etc.) at screening. Participants who are co-colonized with PA and SA or with PA or SA and with other bacteria are also excluded.
- History of positive sputum culture for non-tuberculous mycobacterium within the previous 6 months.
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Any physical abnormality which limits the ability to collect regular sputum specimens.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Timothy Aksamit, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available