Evaluating saline irrigation for treating retained pleural infections
Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections (LYTICS +)
This study is testing if adding saline irrigation to standard treatment can help people with retained pleural infections feel better and recover faster.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06713382 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to assess the efficacy and safety of saline irrigation as an adjunct therapy for patients with retained pleural infections. It involves a two-arm design where one group receives standard care, including antibiotics and chest tube placement, while the other group receives saline irrigation in addition to standard care. The study will measure outcomes such as the reduction in pleural effusion volume using imaging techniques. The hypothesis is that saline irrigation could enhance the effectiveness of intrapleural fibrinolytic therapy in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with purulent pleural fluid or specific biochemical markers indicating severe pleural infection.
Not a fit: Patients with significant comorbidities, pregnant individuals, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with persistent pleural infections.
How similar studies have performed: While the use of saline irrigation in this context is novel, other studies have explored similar adjunct therapies with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Adnan Majid, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Adnan Majid, MD
- Email: amajid@bidmc.harvard.edu
- Phone: 6179016430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.