Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-29 @ 5:38 PM
Study NCT ID:
NCT07095361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONLY ONCE
Brief Summary:
The goal of this clinical trial is to find out if giving certain medications once a day works just as well as giving them twice a day to treat infections around the lungs (called pleural infections). These medications-tissue plasminogen activator (tPA) and deoxyribonuclease (DNase)-are placed through a chest tube into the space between the lung and the chest wall to help clear out the infection.
The investigators are trying to learn:
* Does using the medicine once a day work just as well as using it twice a day?
* Are there any differences in outcomes between patients who get the medicine once a day versus twice a day?
* Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?
Participants will:
* Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung.
* Be asked to give permission to join the study.
* Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.
The investigators are trying to learn:
* Does using the medicine once a day work just as well as using it twice a day?
* Are there any differences in outcomes between patients who get the medicine once a day versus twice a day?
* Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?
Participants will:
* Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung.
* Be asked to give permission to join the study.
* Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: