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New treatment option for Pleural Infection Bacterial
Official title Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
ClinicalTrials.gov ID: NCT07095361
What this study is testing
What is Fibrinolytic once daily?
Fibrinolytic once daily is an investigational medicine, given as an once-daily, being studied as a potential treatment for pleural infection bacterial.
Also referred to as once daily lytics, tPA once daily.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent obtained from patient or patient's legally authorized representative (LAR) to participate in the study and HIPAA...
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- Patient is admitted to the hospital and with a pleural effusion that is drained with a small-bore chest tube or one that allows for administration of...
- Pleural fluid that is one of the following: (i) Macroscopically purulent or pleural fluid gram stain or culture positive for bacteria (ii) potential...
You likely can't join if
- Known pregnancy or lactating females
- Prisoners
- Age \<18 years at time of consent
- Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission
- Known sensitivity or allergic reaction to DNAse or tPA
- Coincidental stroke, major hemorrhage (requiring blood transfusions within the last 5 days), major trauma, or major surgery within the last 5 days
See the full eligibility criteria
- Written informed consent obtained from patient or patient's legally authorized representative (LAR) to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- Patient is admitted to the hospital and with a pleural effusion that is drained with a small-bore chest tube or one that allows for administration of IET
- Pleural fluid that is one of the following: (i) Macroscopically purulent or pleural fluid gram stain or culture positive for bacteria (ii) potential of hydrogen (pH) \ 1,000 IU/L
- Patient is deemed a candidate to receive intrapleural enzyme therapy as defined by having a residual collection or persistent sepsis 24 hours after initial chest tube placement
- Known pregnancy or lactating females
- Prisoners
- Age \<18 years at time of consent
- Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission
- Known sensitivity or allergic reaction to DNAse or tPA
- Coincidental stroke, major hemorrhage (requiring blood transfusions within the last 5 days), major trauma, or major surgery within the last 5 days
- Previous pneumonectomy or active bronchopleural fistula on the affected side
- Therapeutic systemic anticoagulation or antiplatelet agents that cannot held for more than 48 hours prior to IET administration
- Expected survival of less than 3 months due to a pathologic condition other than that causing the pleural infection
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Lebanon, New Hampshire, United States
- Chapel Hill, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Chicago, Illinois, United States; Detroit, Michigan, United States; Lebanon, New Hampshire, United States; Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.