Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]
Recruiting
Phase 2
Interventional Study
Pleural Effusion Associated With Pulmonary Infection
Pleural Effusion Disorder
Pleural Effusions
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 96 (estimated)
- Sponsor
- Beth Israel Deaconess Medical Center · Other
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About This Trial
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 salin…
Trial Locations
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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 dr…
Contacts