Prolonged Air LeakNCT03943511
Discharged With Indwelling Chest Tube and Valve
A study testing Oral Antibiotics-Close Monitoring in people with Prolonged Air Leak, run by Mayo Clinic at 2 sites in United States.
Trial summary
This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Air Leak
- What is being tested?
- Oral Antibiotics-Close Monitoring
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2019to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- ≥ 18 years of age
- Male and Female
- Consultation with a thoracic surgeon
- Discharge from the hospital with a chest tube and valve in place
- Subject is able to understand the study procedures and provide informed consent.
Who cannot join
- Pregnancy
- Allergy to Keflex and Clindamycin
- Special consideration should be taken in enrolling subjects with preexisting conditions that can be exacerbated by antibiotic use but are allowed at the discretion of the treating physician.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Study Evaluating Patients Discharged With Indwelling Chest Tube and Valve
This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.
Read the detailed description
This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be screened prior to discharging from the hospital and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained the subject will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped. The subject will be followed until they have their chest tube removed.
- Conditions
- Prolonged Air Leak
- Being tested
- Oral Antibiotics-Close Monitoring, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Antibiotics-Close MonitoringOther
To receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve.
Standard of CareOther
No calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Oral Antibiotics Receives: Other: Oral Antibiotics-Close Monitoring |
| Group 2 | Active comparator | Standard of Care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in empyema in patient's discharging with an indwelling chest tube and valve.
The proportion of patients having 30-day empyema in the two treatment arms will be estimated and reported.
Measured: 30 days post discharge
Secondary outcomes (1)
Change of 30-day readmission in patient's discharging with an indwelling chest tube and valve.
The proportion of patients having a 30-day readmission in the two treatment arms will be estimated and reported.
Measured: 30 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start7 Oct 2019
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Why it stopped: Low accrual, end of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Air LeakStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K Robert Shen, Mayo Clinic
- Investigators
- K. Robert Shen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943511
- Sponsor's protocol ID
- 17-007774
- Status last verified
- Oct 2025
- First submitted
- 7 May 2019
- Last updated
- 7 Oct 2025
- 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 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating Patients Discharged With Indwelling Chest Tube and Valve
- ClinicalTrials.gov ID
- NCT03943511
- Acronym / sponsor ID
- 17-007774
- Conditions
- Prolonged Air Leak
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual, end of funding
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 9 May 2019 (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.
This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.
Detailed description
This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be screened prior to discharging from the hospital and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained the subject will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped. The subject will be followed until they have their chest tube removed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Oral Antibiotics-Close MonitoringOral Antibiotics |
| Group 2 | Active comparator | Other: Standard of CareStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years of age
- Male and Female
- Consultation with a thoracic surgeon
- Discharge from the hospital with a chest tube and valve in place
- Subject is able to understand the study procedures and provide informed consent.
Key exclusion criteria (3 listed)
- Pregnancy
- Allergy to Keflex and Clindamycin
- Special consideration should be taken in enrolling subjects with preexisting conditions that can be exacerbated by antibiotic use but are allowed at the discretion of the treating physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Antibiotics-Close MonitoringTo receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve. | Other | Group 1 |
| Standard of CareNo calls from the care team but waiting for the subject to contact the care team when the air leak has stopped. | Other | Group 2 |
Primary outcome
Change in empyema in patient's discharging with an indwelling chest tube and valve.
Time frame: 30 days post discharge
The proportion of patients having 30-day empyema in the two treatment arms will be estimated and reported.
1 secondary outcome
Change of 30-day readmission in patient's discharging with an indwelling chest tube and valve.
Time frame: 30 days post discharge
Results and safety
The study was stopped early (reason given: Low accrual, end of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
K. Robert Shen, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Antibiotics-Close Monitoring in people with Prolonged Air Leak, run by Mayo Clinic at 2 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 5 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: stopped early, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early (reason given: Low accrual, end of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in empyema in patient's discharging with an indwelling chest tube and valve. (time frame: 30 days post discharge). 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 7 Oct 2025.