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TerminatedNCT03943511Updated Oct 7, 2025

Discharged With Indwelling Chest Tube and Valve

An interventional study of Oral Antibiotics-Close Monitoring and Standard of Care in Prolonged Air Leak, sponsored by Mayo Clinic. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-07.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Prevention

Why this study was terminated
Low accrual, end of funding
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Prolonged Air Leak
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ≥ 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Group 1

    Oral Antibiotics

    Other: Oral Antibiotics-Close Monitoring

  • Active comparator
    Group 2

    Standard of Care

    Other: Standard of Care

Interventions

  • OtherOral Antibiotics-Close Monitoring

    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.

  • OtherStandard of Care

    No calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 30 days post discharge

07

Study locations

2 sites
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03943511
Lead sponsor
Mayo Clinic
Responsible party
K Robert Shen (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 9, 2019
Start date
Oct 7, 2019
Primary completion
Nov 20, 2023
Completion
Nov 20, 2023
Last update
Oct 7, 2025

Study contacts

K. Robert Shen, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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