PI: K. Robert Shen, MD, Mayo Clinic Rochester
|
Phase |
Phase II |
|
Methodology |
Randomized |
|
Overall Study Duration |
5 years |
|
Subject Participation Duration |
30 Days |
|
Objectives |
Primary Objective To assess the efficacy of antibiotics and closer monitoring on decreasing empyema in patients discharging with a chest tube and valve in place as measured by documented empyema following discharge. Secondary Objective To assess the efficacy of antibiotics and closer monitoring on decreasing hospital readmissions while the chest tube and valve are in place as measured by readmission to the hospital following hospital discharge after the initial surgical intervention. |
|
Number of Subjects |
560 |
|
Diagnosis and Main Inclusion Criteria |
Discharge from the hospital with an indwelling chest tube and valve in place |
|
Study Treatment |
Oral antibiotics and close monitoring (defined as twice weekly telephone calls by a member of the care team) |
|
Reference Treatment |
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) |
|
Statistical Methodology |
Comparison of the rate of empyema and readmission in the two arms of the study |
