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Saline Irrigation for Bacterial Pleural Effusion ([LYTICS+] Trial)

Phase 2

Waitlist Available

Led By Adnan Majid, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of purulent pleural fluid or pleural fluid analysis with glucose < 40 mg/dL

Age ≥18 years

Must not have

Patients with significant comorbidities that may interfere with the study outcomes (e.g., terminal malignancy)

Inability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new saline irrigation technique alongside standard treatments for pleural infections. The goal is to see if adding saline irrigation to the treatment plan can help improve outcomes for patients with persistent infections

Who is the study for?

This trial is for patients with persistent pleural infections who haven't responded well to antibiotics and tube drainage. It's not suitable for those at high risk of bleeding where standard therapy using intrapleural fibrinolytic therapy (IPFT) isn't safe.

What is being tested?

The study tests if adding saline irrigation to IPFT can improve outcomes in treating retained pleural infections. Patients will be compared based on inflammation levels, imaging results, fluid drained, chest tube time, hospital stay length, and need for surgery.

What are the potential side effects?

Potential side effects may include discomfort from the procedure and complications related to additional fluid introduction into the pleura. The safety comparison between saline irrigation plus IPFT versus IPFT alone will be a focus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pleural fluid is infected or has low glucose levels.

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I am 18 years old or older.

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My pleural fluid is infected or has a pH of 7.2 or lower.

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My pleural fluid is infected or has high LDH levels.

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My chest tube drained less than 200 mL in the last 24 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have other major health issues that could affect the study.

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I am unable to understand or sign the consent form.

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I have a complex fluid buildup due to inflammation.

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I have fluid in my chest due to liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at discharge (7-14 days post-intervention initiation), and follow-up (3 weeks +/- 3 days and 6 weeks +/- 3 days post-discharge). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in Pleural Effusion Volume

Secondary study objectives

Chest tube duration

Complications related to the interventions

Length of hospital stay

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard Care + Saline IrrigationExperimental Treatment1 Intervention

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

Group II: Standard of careActive Control1 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

0 / 9Eligibility criteria met