Discharged With Indwelling Chest Tube and Valve

NCT03943511 | Terminated

• 1 other identifier: 17-007774
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prolonged Air Leak

Outcome Measures

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.

  30 days post discharge

Secondary Outcomes (1)

• Change of 30-day readmission in patient's discharging with an indwelling chest tube and valve.

  30 days post discharge

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Oral Antibiotics

Other: Oral Antibiotics-Close Monitoring

Group 2

ACTIVE COMPARATOR

Standard of Care

Other: Standard of Care

Interventions

Oral Antibiotics-Close Monitoring OTHER

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.

Group 1

Standard of Care OTHER

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• K. Robert Shen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: October 7, 2019
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)