Remote Sputum Collection in Cystic Fibrosis

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Pennsylvania
Study ID
NCT06950892
Status
Recruiting
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Conditions

  • Cystic Fibrosis
  • Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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

Locations (3)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206
Andrea McKenzie
[email protected]
303-398-1453
Milene Saveedra, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Noah Lechtzin, MD
[email protected]
443-287-7332
Noah Lechtzin, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Krista Ludwig
267-283-6223
Gina Hong, MD (PRINCIPAL_INVESTIGATOR)

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By research site
National Jewish Health· Denver, COJohns Hopkins University· Baltimore, MDUniversity of Pennsylvania· Philadelphia, PA

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