NCT06713382 Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]
| NCT ID | NCT06713382 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Pleural Effusion Associated With Pulmonary Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2026-11-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 96 participants in total. It began in 2025-04-10 with a primary completion date of 2026-11-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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). 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.
Contact & Investigator
Adnan Majid, MD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT06713382 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Effusion Associated With Pulmonary Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06713382 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06713382 currently recruiting?
Yes, NCT06713382 is actively recruiting participants. Contact the research team at amajid@bidmc.harvard.edu for enrollment information.
Where is the NCT06713382 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06713382 clinical trial?
NCT06713382 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Adnan Majid, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 96 participants.