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Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Study acronym: ONLY ONCE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Trial sites expanded: 6 → 11 locations · Secondary endpoints: details revised at 3 of 10 entries · Eligibility criteria expanded, about 1 word Show 3 more changesShow less
    • Trial sites expanded: 6 → 11 locations
    • Secondary endpoints: details revised at 3 of 10 entries
    • Eligibility criteria expanded, about 1 word
  2. Trial sites expanded: 2 → 6 locationsv4
  3. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Jun 2027 to Sep 30, 2028 · Study sites: 1 to 2 · Start date changed from estimate of Sep 2025 to Sep 11, 2025 · 1 morev3 Show 4 more changesShow less
    • Primary and study completion dates: Jun 2027 to Sep 30, 2028
    • Study sites: 1 to 2
    • Start date changed from estimate of Sep 2025 to Sep 11, 2025
    • Collaborators expanded, about 16 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Aug 1, 2025 to Sep 2025 Eligibility criteria shortened, about 37 words · Secondary endpoints revised (10)v2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 37 words
    • Secondary endpoints revised (10)

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07095361
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Northwestern Memorial Hospital, Henry Ford Health System, Yale University, Rush University Medical Center, Dartmouth-Hitchcock Medical Center
Conditions Pleural Infection Bacterial, Pleural Infections, Pleural Infections and Inflammations, Empyema, Pleural, Empyema, Complicated Pleural Effusion/ Empyema, Pleural Effusion Associated With Pulmonary Infection, Pleural Effusion
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov