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

NCT06713382 | Recruiting Phase 2 FDA Device

• 1 other identifier: LYTICS+
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pleural Effusion Associated With Pulmonary Infection; Pleural Effusion Disorder; Pleural Effusions

Keywords

Pleural Effusion; Thoracentesis; Tissue Plasminogen Activator; DNase; Therapeutic Irrigation

Outcome Measures

Primary Outcomes (1)

• Reduction in Pleural Effusion Volume

  This outcome assesses the percentage reduction in pleural effusion volume from baseline, measured by CT (volumetry) and ultrasound using the Balik formula. Efficacy is defined as a 10% or greater improvement in pleural effusion volume reduction in the intervention group (standard care plus pleural saline irrigation) compared to the control group (standard care alone). Success is determined by achieving a ≥10% additional reduction in pleural effusion volume in the intervention group compared to the control group, indicating a clinically meaningful improvement with adjunctive saline irrigation.

  Baseline (prior to intervention). During hospitalization (before each IPFT and irrigation session, anticipated every 24 hours, up to 14 days). At discharge (7-14 days post-intervention initiation). Follow-up at 3 weeks (+/- 3 days) and 6 weeks (+/- 3 day

Secondary Outcomes (7)

• Rate of pleural infection resolution

  Baseline, at discharge (7-14 days post-intervention initiation), and follow-up (3 weeks +/- 3 days and 6 weeks +/- 3 days post-discharge).

• Chest tube duration

  Through hospitalization (up to 14 days).

• Length of hospital stay

  Through hospitalization (anticipated 7-14 days).

• Complications related to the interventions

  During hospitalization (up to 14 days) and at follow-up (3 weeks +/- 3 days and 6 weeks +/- 3 days post-discharge).

• Pain associated with interventions

  During hospitalization (measured immediately after each intervention session, anticipated up to 14 days).

Study Arms (2)

Standard of care

NO INTERVENTION

Patients will receive the current standard of care, which includes antibiotics, chest tube placement, and intrapleural tPA/DNase therapy based on their clinical criteria

Standard Care + Saline Irrigation

EXPERIMENTAL

In addition to the standard care, patients in this group will receive pleural saline irrigation through the chest tube immediately after IPFT. The amount of saline will be determined by free-flow saline infusion up to 250 mL. This maneuver will be repeated every time that IPFT is administered, based on treating physician's criteria

Combination Product: Pleural Saline Irrigation

Interventions

Pleural Saline Irrigation COMBINATION_PRODUCT

This intervention, Pleural Saline Irrigation, involves the administration of up to 250 mL of sterile saline solution into the pleural cavity through a chest tube immediately following each intrapleural tPA/DNase (IPFT) therapy session. The saline irrigation is intended to aid in clearing infected pleural fluid and reducing pleural effusion volume. This maneuver is repeated based on the treating physician's criteria, differentiating it from standard care, which includes only antibiotics, chest tube placement, and IPFT without saline irrigation. The irrigation is expected to enhance infection resolution and may impact chest tube duration and the frequency of pleural interventions.

Standard Care + Saline Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Adnan Majid, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adnan Majid, MD

CONTACT

6179016430; amajid@bidmc.harvard.edu

Maria C Lopez, MD

CONTACT

7869678448; mlopezgi@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: \- Control Group (Standard Care): Patients will receive the current standard of care, which includes antibiotics, chest tube placement, and intrapleural tPA/DNase therapy based on the criteria outlined above. \- Intervention Group (Standard Care + Saline Irrigation): In addition to the standard care, patients in this group will receive pleural saline irrigation through the chest tube immediately after IPFT. The amount of saline will be determined by free-flow saline infusion up to 250 mL. This maneuver will be repeated every time that IPFT is administered, based on treating physician's criteria

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 3, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

US (1)