Who is eligible for clinical trial NCT06713382?

Participants must meet protocol criteria for Pleural Effusion Associated With Pulmonary Infection. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06713382 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-26

Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +] (NCT06713382)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Beth Israel Deaconess Medical Center

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this protocol is to conduct a pilot prospective non-blind clinical trial to evaluate the efficacy and safety of a novel saline irrigation technique as an adjunct to standard interventions for treating retained pleural infections. Intrapleural fibrinolytic therapy (IPFT) is commonly used for infections not adequately managed with antibiotics and intercostal tube drainage, while saline irrigation serves as an alternative for cases with a high bleeding risk where IPFT is not feasible. The efficacy of saline irrigation combined with IPFT remains unexplored. The hypothesis is that saline irrigation could be an effective and safe addition to IPFT for patients with persistent pleural infections. The specific aims of the study include: Determine the efficacy of saline irrigation as add-on therapy to IPFT: Compare the clinical outcomes of patients receiving saline irrigation combined with IPFT to those receiving IPFT alone to determine if the addition of saline irrigation offers significant benefits. Outcomes include changes in inflammatory markers, imaging characteristics (echography and CT), volume of pleural fluid drained, chest tube duration, hospital length of stay, and the need for subsequent surgical intervention. Assess the safety and tolerability of saline irrigation plus IPFT: Compare complications and patient comfort in those receiving saline irrigation combined with IPFT to those receiving IPFT alone.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (6 items).

Location: Beth Israel Deaconess Medical Center — Boston, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age ≥18 years.
Presence of purulent pleural fluid or pleural fluid analysis with any of the following:
pH ≤ 7.2.
Glucose \< 40 mg/dL.
LDH \> 1000 IU/L.
Presence of bacterial or fungal organisms on Gram stain or culture.
Chest tube placement with less than 200 mL drainage in 24 hours.
Indication for IPFT treatment based on treating physician's criteria.
Radiographic evidence of septations on chest ultrasound (US) or loculations on low-dose chest computed tomography (CT).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Inability to provide informed consent.
Pregnant patients.
Patients with significant comorbidities that may interfere with the study -outcomes (e.g., terminal malignancy).
Complicated sympathetic effusion.
Hepatic hydrothorax.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Beth Israel Deaconess Medical Center — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗