A Study to Investigate Bacterial Load, Patient Characteristics and Exploratory Biomarkers in Adult Patients with Cystic Fibrosis or Non-Cystic Fibrosis Bronchiectasis

Overview

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Aksamit, M.D.

Open for enrollment

Contact information:

Samantha Hughes CCRP

(507) 266-1026

Hughes.Samantha@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20491418

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