Pleural Effusion Associated With Pulmonary InfectionPhase 2[LYTICS+]NCT06713382
Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]
A Phase 2 study testing Pleural Saline Irrigation in people with Pleural Effusion Associated With Pulmonary Infection and Pleural Effusion Disorder, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion Associated With Pulmonary Infection, Pleural Effusion Disorder, Pleural Effusions
- What is being tested?
- Pleural Saline Irrigation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2025to 20 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Adnan Majid, MD, 6179016430, amajid@bidmc.harvard.edu
Adnan Majid, MD
About this study
Official title: Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections (LYTICS +)
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:
Read more
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.
Read the detailed description
Objective:
To evaluate the efficacy and safety of pleural saline irrigation as an adjunct therapy in patients with retained pleural infection, comparing it with the standard of care (antibiotics, chest tube placement, and lytics).
Study Design:
This is a prospective, two-arm pilot trial to be conducted at Beth Israel Deaconess Medical Center. The study will involve two groups: one receiving standard care and the other receiving pleural saline irrigation in addition to standard care. Patients will be assigned to one of the two study arms (standard care vs. standard care + saline irrigation) using block randomization to ensure balanced group sizes.
Interventions:
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 each time IPFT is administered, based on the treating physician's criteria.
Outcomes:
Primary Endpoint:
The primary outcome is the reduction in pleural effusion volume, measured with CT (volumetry) and US (Balik formula), with efficacy defined as a 10% or greater improvement compared to standard care alone. Success will be determined by a ≥10% additional reduction in pleural effusion volume compared to regular interventions.
Secondary Endpoints:
Rate of pleural infection resolution based on clinical (fever), radiographic (ultrasound and CT signs of complicated pleural effusion), and laboratory (inflammatory markers) data.
Chest tube duration. Duration of hospital stay. Complications related to the interventions. Pain associated with the interventions. Need for surgery. Overall mortality.
Data Collection and Variables:
A range of variables will be collected to assess both primary and secondary outcomes. Primary outcome measures will focus on the percentage reduction in pleural effusion volume, assessed through chest ultrasound or CT scan at baseline and during follow-up. Secondary outcomes include adverse events related to the intervention, such as hypothermia, chest discomfort, and fluid overload. The incidence of pleural infection-related complications, recurrence of infection, and the need for further pleural interventions, such as thoracentesis or chest tube placement, will be monitored. Chest tube duration, fever duration, leukocytosis, neutrophil count, and blood culture results will be evaluated to track infection resolution and patient recovery.
Subgroup analysis will be performed based on pleural fluid volume and characteristics (pH, glucose, LDH), antibiotic duration, and follow-up imaging results, both at the end of therapy and 3-6 weeks later. Other intervention-related variables, such as the amount and frequency of saline irrigation, chest tube size, intrapleural tPA/DNase doses, and the total volume of fluid drained, will also be collected to further assess the intervention's efficacy and safety.
- Conditions
- Pleural Effusion Associated With Pulmonary Infection, Pleural Effusion Disorder, Pleural Effusions
- Being tested
- Pleural Saline Irrigation
- Keywords
- Pleural Effusion, Thoracentesis, Tissue Plasminogen Activator, DNase, Therapeutic Irrigation
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural Saline IrrigationCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: Pleural Saline Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Determined through clinical markers (fever resolution), radiographic improvement (ultrasound and CT signs of effusion), and laboratory indicators (inflammatory markers and blood cultures).
Measured: 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
Total duration of chest tube placement from insertion to removal.
Measured: Through hospitalization (up to 14 days).
Length of hospital stay
Total length of stay from admission to discharge.
Measured: Through hospitalization (anticipated 7-14 days).
Complications related to the interventions
Includes adverse events such as hypothermia, chest discomfort, fluid overload, and infection recurrence.
Measured: 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
Level of pain reported during procedures, measured using a standardized pain scale (e.g., Visual Analog Scale).
Measured: During hospitalization (measured immediately after each intervention session, anticipated up to 14 days).
Need for surgical intervention
Incidence of surgical intervention required due to unresolved pleural infection or complications.
Measured: Through study completion (up to 6 weeks post-discharge).
Overall mortality
Death from any cause during the study period.
Measured: Through study completion (up to 6 weeks post-discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start10 Apr 2025
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusion Associated With Pulmonary InfectionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- \- 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
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Majid, MD, Beth Israel Deaconess Medical Center
- Investigators
- Adnan Majid, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713382
- Sponsor's protocol ID
- LYTICS+
- Acronym
- [LYTICS+]
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections (LYTICS +)
- ClinicalTrials.gov ID
- NCT06713382
- Acronym / sponsor ID
- [LYTICS+] / LYTICS+
- Conditions
- Pleural Effusion Associated With Pulmonary Infection, Pleural Effusion Disorder, Pleural Effusions
- Keywords
- Pleural Effusion, Thoracentesis, Tissue Plasminogen Activator, DNase, Therapeutic Irrigation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective:
To evaluate the efficacy and safety of pleural saline irrigation as an adjunct therapy in patients with retained pleural infection, comparing it with the standard of care (antibiotics, chest tube placement, and lytics).
Study Design:
This is a prospective, two-arm pilot trial to be conducted at Beth Israel Deaconess Medical Center. The study will involve two groups: one receiving standard care and the other receiving pleural saline irrigation in addition to standard care. Patients will be assigned to one of the two study arms (standard care vs. standard care + saline irrigation) using block randomization to ensure balanced group sizes.
Interventions:
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 each time IPFT is administered, based on the treating physician's criteria.
Outcomes:
Primary Endpoint:
The primary outcome is the reduction in pleural effusion volume, measured with CT (volumetry) and US (Balik formula), with efficacy defined as a 10% or greater improvement compared to standard care alone. Success will be determined by a ≥10% additional reduction in pleural effusion volume compared to regular interventions.
Secondary Endpoints:
Rate of pleural infection resolution based on clinical (fever), radiographic (ultrasound and CT signs of complicated pleural effusion), and laboratory (inflammatory markers) data.
Chest tube duration. Duration of hospital stay. Complications related to the interventions. Pain associated with the interventions. Need for surgery. Overall mortality.
Data Collection and Variables:
A range of variables will be collected to assess both primary and secondary outcomes. Primary outcome measures will focus on the percentage reduction in pleural effusion volume, assessed through chest ultrasound or CT scan at baseline and during follow-up. Secondary outcomes include adverse events related to the intervention, such as hypothermia, chest discomfort, and fluid overload. The incidence of pleural infection-related complications, recurrence of infection, and the need for further pleural interventions, such as thoracentesis or chest tube placement, will be monitored. Chest tube duration, fever duration, leukocytosis, neutrophil count, and blood culture results will be evaluated to track infection resolution and patient recovery.
Subgroup analysis will be performed based on pleural fluid volume and characteristics (pH, glucose, LDH), antibiotic duration, and follow-up imaging results, both at the end of therapy and 3-6 weeks later. Other intervention-related variables, such as the amount and frequency of saline irrigation, chest tube size, intrapleural tPA/DNase doses, and the total volume of fluid drained, will also be collected to further assess the intervention's efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- - 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Combination Product: Pleural Saline IrrigationIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleural Saline IrrigationThis 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. | Combination product | Standard Care + Saline Irrigation |
Primary outcome
Reduction in Pleural Effusion Volume
Time frame: 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
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.
7 secondary outcomes
Rate of pleural infection resolution
Time frame: 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
Time frame: Through hospitalization (up to 14 days).
Length of hospital stay
Time frame: Through hospitalization (anticipated 7-14 days).
Complications related to the interventions
Time frame: 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
Time frame: During hospitalization (measured immediately after each intervention session, anticipated up to 14 days).
Need for surgical intervention
Time frame: Through study completion (up to 6 weeks post-discharge).
Overall mortality
Time frame: Through study completion (up to 6 weeks post-discharge).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adnan Majid, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pleural Saline Irrigation in people with Pleural Effusion Associated With Pulmonary Infection and Pleural Effusion Disorder, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adnan Majid, MD (6179016430, amajid@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Pleural Effusion Volume (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.