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Oral Antibiotics + Monitoring for Prolonged Air Leak
N/A
Waitlist Available
Led By K. Robert Shen, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Discharge from the hospital with a chest tube and valve in place
Consultation with a thoracic surgeon
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post discharge
Awards & highlights
Study Summary
This trial is testing whether giving oral antibiotics and making phone calls to check on patients' chest tubes and valves helps them recover better than the standard of care.
Who is the study for?
This trial is for men and women over 18 who are being discharged from the hospital with a chest tube and valve in place after experiencing prolonged air leaks. They must understand the study, consent to it, and have consulted with a thoracic surgeon. People allergic to Keflex or Clindamycin, pregnant individuals, or those with conditions worsened by antibiotics (subject to physician's discretion) cannot join.Check my eligibility
What is being tested?
The study compares two approaches for patients sent home with an indwelling chest tube and valve: one group receives oral antibiotics and twice-weekly phone check-ups; the other follows standard care without routine calls but waits for patients to report when their air leak stops.See study design
What are the potential side effects?
Potential side effects may include reactions related to antibiotic use such as digestive issues, allergic responses if not previously identified as allergic to prescribed medications, and possibly exacerbation of preexisting conditions sensitive to antibiotic treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was discharged from the hospital with a chest tube and valve.
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I have consulted with a thoracic surgeon.
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I am 18 years old or older.
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I understand the study and can agree to participate.
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I am either male or female.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in empyema in patient's discharging with an indwelling chest tube and valve.
Secondary outcome measures
Change of 30-day readmission in patient's discharging with an indwelling chest tube and valve.
Trial Design
2Treatment groups
Active Control
Group I: Group 1Active Control1 Intervention
Oral Antibiotics
Group II: Group 2Active Control1 Intervention
Standard of Care
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,491 Total Patients Enrolled
K. Robert Shen, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have a preexisting condition that can get worse with antibiotics, the study team will consider this before enrolling you.I was discharged from the hospital with a chest tube and valve.You are pregnant.I have consulted with a thoracic surgeon.I am 18 years old or older.I understand the study and can agree to participate.I am either male or female.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enlistment available for this clinical trial at the present time?
"Clinicaltrials.gov indicates that this particular trial, which was originally posted on October 7th 2019 and last updated October 25 2022 is not presently recruiting patients. Nevertheless, there are other studies actively seeking participants at the moment."
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