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Clinical Trial NCT06434324 for Pleural Infection is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empyema/Complicated Parapneumonic Effusion 60

Recruiting
Clinical Trial NCT06434324 is an interventional study for Pleural Infection that is recruiting. It started on March 29, 2025 with plans to enroll 60 participants. Led by Mayo Clinic, it is expected to complete by March 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
The purpose of this study is to see if there is any benefit in adding saline irrigation through a chest tube to the standard course of treatment for people diagnosed or suspected of having a pleural space infection.
Detailed Description
Pleural space infections portend considerable morbidity and require procedural and sometimes surgical intervention in the context of prolonged hospital stays (median length of stay has been reported as 14-19 days) for definitive management. Key aspects of management include pleural space evacuation and appropriate antimicrobial therapy. The antimicrobial regimen is initiated intravenously and is often transitioned to...Show More
Official Title

A Study to Evaluate the Efficacy of Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in the Management of Empyema/Complicated Parapneumonic Effusion

Conditions
Pleural Infection
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 23-013234
  • HT9425-24-C-0010 (Other Grant/Funding Number) (US Dept of Defense)
NCT ID Number
NCT06434324
Start Date (Actual)
2025-03-29
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-03
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSaline Irrigation Group
Subjects will receive twice daily fibrinolytic therapy in addition to daily saline irrigation through their chest tube until the treating physician determines that the pleural space has been adequately evacuated
Saline Irrigation
250 cc waves of warmed saline irrigation (up to 2000 cc) through thoracostomy tube on a daily basis
No InterventionStandard of Care Group
Subjects will receive twice daily fibrinolytic therapy through their chest tube until the treating physician determines that the pleural space has been adequately evacuated
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Adequate pleural space evacuation
Number of intrapleural fibrinolytic doses to achieve adequate pleural space evacuation (defined as \<=2.5 cm separation between parietal and visceral pleural layers on bedside ultrasound or no more than small residual effusion on clinically-directed CT chest imaging).
Approximately 3 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Need for additional interventions
Number of additional interventions to achieve satisfactory pleural space evacuation, such as additional paired lytics beyond 6 doses, ipsilateral thoracentesis, additional ipsilateral thoracostomy tube placement, surgical intervention, or discharge with an empyema tube in situ.
Approximately 10 days
Thoracostomy tube days
Number of thoracostomy tube days from the time that treatment is initiated
Approximately 10 days
Number of hospital days
Number of hospital days from the time that treatment is initiated
Approximately 14 days
Pain tolerance of pleural space irrigation
Measured using a visual analog scale (VAS) questionnaire that assesses pain experienced during treatment utilizing a scale of 0 to 10, with 10 meaning the worst pain imaginable.
Approximately 3 days
Number of adverse events
Total number of adverse events including new/worsened respiratory failure, septic shock, hemothorax
Approximately 10 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Purulent pleural fluid versus pleural fluid analysis demonstrating pH <7.2, glucose <60 mg/dL, positive Gram stain, or positive pleural fluid culture versus multiseptated pleural effusion with infection at top of differential diagnosis
  • Patients initiating intrapleural lytic therapy under the care of the Interventional Pulmonary consult service at Mayo Clinic in Rochester, MN

  • Unwillingness to give informed consent
  • Patients with known bleeding diathesis
  • Platelet count <50,000 per μL
  • INR >2.2 (of note, INR can be allowed to drift down or be reversed pharmacologically prior to initiation of intrapleural lytics/saline)
  • Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
  • Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment
  • Incarcerated patients
  • Presence of ipsilateral bronchopleural fistula
  • Current or recent (within past 30 days) presence of tunneled pleural catheter on the same side as the current proven/suspected pleural space infection
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Study Responsible Party
Dagny K. Anderson, Principal Investigator, Principal Investigator, Mayo Clinic
No contact data.
1 Study Locations in 1 Countries

Minnesota

Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Dagny Anderson, MD, Contact, 507-284-3104, [email protected]
Recruiting