Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Adding saline irrigation to standard treatment for pleural infections

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

Run by Mayo Clinic · NCT06434324 · Data updated 2026-11-12

This study is testing if adding saline irrigation through a chest tube to standard treatment can help people with pleural infections get better faster and spend less time in the hospital.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorMayo Clinic
Academic / other
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedMarch 29, 2025
Main results expectedDecember 2026
Study endsMarch 2027
Registry record updatedMarch 30, 2026
Trial IDNCT06434324 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with purulent pleural fluid or specific pleural fluid analysis results indicating infection, who are starting intrapleural lytic therapy.

Probably not a fit

Patients with bleeding disorders, high INR, or those currently on systemic anticoagulation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of saline irrigation through a chest tube in conjunction with standard intrapleural thrombolytic therapy for patients diagnosed with pleural space infections. The research focuses on improving pleural fluid evacuation and reducing hospital stays by potentially diluting bacteria and inflammatory factors in the pleural space. Patients will receive saline irrigation while undergoing standard antimicrobial therapy, and outcomes will be assessed based on clinical and radiographic improvements. The study is conducted at the Mayo Clinic, leveraging their expertise in interventional pulmonary care.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery times and reduced need for surgical interventions in patients with pleural infections.

How similar studies have gone: Previous studies, such as the MIST 2 trial, have shown success with similar approaches in managing pleural space infections.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting

Study contacts

  • Principal investigator: Dagny Anderson, MD — Mayo Clinic

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.