Cystic FibrosisRESCUeNCT06950892
Remote Sputum Collection in Cystic Fibrosis
An observational study of Cystic Fibrosis and Infections, run by University of Pennsylvania at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Infections
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jan 2025to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with cystic fibrosis from three cystic fibrosis centers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Noah Lechtzin, MD, 443-287-7332, nlechtz@jhmi.edu
Noah Lechtzin, MD
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Andrea McKenzie, 303-398-1453, mckenzieam@njhealth.org
Milene Saveedra, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Krista Ludwig, 267-283-6223
Gina Hong, MD
- Recruiting
Providence Medical Research Center
Spokane, Washington, 99204
Lauren Wilcox, 509-474-3836, Lauren.wilcox@providence.org
Allison Lambert, MD, MHS
About this study
Official title: Remote Sputum Collection in Adults With Cystic Fibrosis
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.
Read the detailed description
The clinical standard of care of people with CF is conducting sputum culture for infection surveillance and detection. However, the introduction of Elexacaftor/Tezacaftor/Ivacaftor (ETI) and adoption of telehealth encounters have reduced the number of respiratory cultures and shifted the types of respiratory sampling over the past three years. People with CF on ETI who were previously able to expectorate sputum are now less likely to produce sputum during clinic visits. As a result, there has been an increase in oropharyngeal (OP) swab sampling in adults. OP swabs lack sensitivity for bacterial detection. Despite clinical improvements related to ETI use (eg lung function, decreased pulmonary exacerbation rates), chronic bacterial infection persists in CF airways. Therefore, additional non-invasive methods for infection surveillance are needed. The investigators propose remote collection of sputum is a promising option for detecting bacteria and fungi in people with CF. Yet, delayed processing and temperature storage conditions may impact the recovery of CF pathogens in remotely collected sputa. To address this, the investigators propose an observational study testing the accuracy and validity of remotely collected sputum. The study will achieve this by comparing CF pathogen detection by culture in sputum samples collected at home to those obtained through induced sputum and OP swabs during clinic visits. The aims of the study are to:
- Determine the diagnostic performance of home-collected sputum samples for CF pathogen detection compared to clinic-based induced sputum collection.
- Determine if CF pathogen detection is greater in home-collected sputum compared to OP swab sampling.
- Determine if storage temperature conditions (ambient versus 4°C) during overnight shipping influence bacterial identification and abundance in home-collected sputum.
The study will enroll 150 participants. The sensitivity, specificity, overall accuracy, positive predictive value (PPV), and negative predictive value (NPV) with 95% confidence intervals will be calculated for the home-collected sputum method and clinic-induced sputum culture performed the local clinical laboratory as the gold standard (Aim 1). A receiver operating characteristic (ROC) curve will be plotted and area under the curve (AUC) will be calculated. Similar analyses will be conducted for Aim 2 using OP swab as the clinical gold standard. For Aim 3, the investigators will conduct non-inferiority analyses to compare pathogen density in ambient and cooled shipping conditions. The findings will provide valuable insights to clinics and laboratories regarding the reliability and acceptability of using home-collected sputum samples for microbiological evaluation. Ultimately, this project has the potential to introduce a non-invasive and minimally burdensome method for infection detection and diagnosis in people with CF.
- Conditions
- Cystic Fibrosis, Infections
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa
- Medical subject headings
- Cystic Fibrosis, Infections, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with cystic fibrosis | People with cystic fibrosis age 18 years or older without a history of solid organ transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pseudomonas aeruginosa positive culture
Measured: at baseline
Secondary outcomes (2)
Culture-positive detection of Staphylococcus aureus, Burkholderia cepacia complex, Aspergillus fumigatus and other CF pathogens.
Measured: at baseline
Bacterial density in sputum measured by colony forming unit.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start15 Jan 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Gina Hong, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950892
- Sponsor's protocol ID
- 857045
- Acronym
- RESCUe
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Sputum Collection in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06950892
- Acronym / sponsor ID
- RESCUe / 857045
- Conditions
- Cystic Fibrosis, Infections
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The clinical standard of care of people with CF is conducting sputum culture for infection surveillance and detection. However, the introduction of Elexacaftor/Tezacaftor/Ivacaftor (ETI) and adoption of telehealth encounters have reduced the number of respiratory cultures and shifted the types of respiratory sampling over the past three years. People with CF on ETI who were previously able to expectorate sputum are now less likely to produce sputum during clinic visits. As a result, there has been an increase in oropharyngeal (OP) swab sampling in adults. OP swabs lack sensitivity for bacterial detection. Despite clinical improvements related to ETI use (eg lung function, decreased pulmonary exacerbation rates), chronic bacterial infection persists in CF airways. Therefore, additional non-invasive methods for infection surveillance are needed. The investigators propose remote collection of sputum is a promising option for detecting bacteria and fungi in people with CF. Yet, delayed processing and temperature storage conditions may impact the recovery of CF pathogens in remotely collected sputa. To address this, the investigators propose an observational study testing the accuracy and validity of remotely collected sputum. The study will achieve this by comparing CF pathogen detection by culture in sputum samples collected at home to those obtained through induced sputum and OP swabs during clinic visits. The aims of the study are to:
- Determine the diagnostic performance of home-collected sputum samples for CF pathogen detection compared to clinic-based induced sputum collection.
- Determine if CF pathogen detection is greater in home-collected sputum compared to OP swab sampling.
- Determine if storage temperature conditions (ambient versus 4°C) during overnight shipping influence bacterial identification and abundance in home-collected sputum.
The study will enroll 150 participants. The sensitivity, specificity, overall accuracy, positive predictive value (PPV), and negative predictive value (NPV) with 95% confidence intervals will be calculated for the home-collected sputum method and clinic-induced sputum culture performed the local clinical laboratory as the gold standard (Aim 1). A receiver operating characteristic (ROC) curve will be plotted and area under the curve (AUC) will be calculated. Similar analyses will be conducted for Aim 2 using OP swab as the clinical gold standard. For Aim 3, the investigators will conduct non-inferiority analyses to compare pathogen density in ambient and cooled shipping conditions. The findings will provide valuable insights to clinics and laboratories regarding the reliability and acceptability of using home-collected sputum samples for microbiological evaluation. Ultimately, this project has the potential to introduce a non-invasive and minimally burdensome method for infection detection and diagnosis in people with CF.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with cystic fibrosis | – | –People with cystic fibrosis age 18 years or older without a history of solid organ transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with cystic fibrosis from three cystic fibrosis centers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pseudomonas aeruginosa positive culture
Time frame: at baseline
2 secondary outcomes
Culture-positive detection of Staphylococcus aureus, Burkholderia cepacia complex, Aspergillus fumigatus and other CF pathogens.
Time frame: at baseline
Bacterial density in sputum measured by colony forming unit.
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gina Hong, MD principal investigator
University of Pennsylvania
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Infections, run by University of Pennsylvania at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krista Ludwig (267-283-6223, Krista.ludwig@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pseudomonas aeruginosa positive culture (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.