Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT06950892

Conditions

Cystic Fibrosis

Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Elexacaftor/Tezacaftor/Ivacaftor or Trikafta improves lung health in people with cystic fibrosis (CF), including decreased cough and mucous production. Diagnosing lung infections has become more challenging due to the decrease in sputum and rise of telehealth services. While the option of collecting sputum samples at home and sending them by mail may be feasible, uncertainty remains about how the collection of samples outside of clinic and delays in testing while in the mail impact infection detection. This study will compare bacterial cultures using sputum samples collected at home versus samples collected in clinic (saline-induced sputum and throat swab). This study seeks to shed light on how valuable home collected samples can be and help us better understand the usefulness of home-collected sputum samples for both clinical and research purposes.

Conditions

Cystic Fibrosis

Infections

Study ID

NCT06950892

Start date

Jan 15, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • People with a diagnosis of cystic fibrosis (CF) based on CF Foundation (CFF) guidelines. The CFF guidelines consider a diagnosis of CF based on: (1) two known disease-causing CFTR mutations (based on historical genetic testing in clinical documentation or PortCF, the CFF patient registry), OR (2) sweat chloride 60 mmol/L (based on historical sweat chloride testing in clinical documentation or PortCF) and phenotypic findings consistent with cystic fibrosis in more than one organ system, OR (3) CFF accredited center physician diagnosis, based on clinical manifestations in the absence of two CFTR mutations with full gene mapping (based on historical genetic testing in clinical documentation or PortCF).
  • Age 18 years old or greater
  • People with the ability to comply with study visits and study procedures as judged by the investigator.

Exclusion Criteria:

  • Solid organ transplant recipients, given the presence of immunosuppression.
  • Those who are unable to tolerate sputum induction (hypertonic saline) or the inability to attempt sputum expectoration.
  • Subjects who do not have access to a FedEx location or pick-up services will be excluded.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Adults with cystic fibrosis

People with cystic fibrosis age 18 years or older without a history of solid organ transplantation.

Primary outcome measure

  • Pseudomonas aeruginosa positive culture [ Time Frame: at baseline ]

Central Contacts and Locations

Central contacts

Krista Ludwig

267-283-6223Krista.ludwig@pennmedicine.upenn.edu

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Andrea McKenzie

303-398-1453mckenzieam@njhealth.org

Principal Investigator:

Milene Saveedra, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Noah Lechtzin, MD

443-287-7332nlechtz@jhmi.edu

Principal Investigator:

Noah Lechtzin, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Krista Ludwig

267-283-6223

Principal Investigator:

Gina Hong, MD

Providence Medical Research Center

Recruiting

Spokane, Washington, United States, 99204

Contacts

Lauren Wilcox

509-474-3836Lauren.wilcox@providence.org

Principal Investigator:

Allison Lambert, MD, MHS

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Cystic Fibrosis
  • Pseudomonas aeruginosa

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-08-19.