Early Pleural Irrigation with Saline vs Standard Care for Complicated Pleural Infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study compares an early pleural saline irrigation strategy to standard care in adults with complicated pleural infections. The primary goal is to see if irrigation reduces treatment failure within 30 days, defined as death, need for thoracic surgery, or requirement for additional intrapleural enzyme therapy. Participants will have confirmed pleural infection with loculated effusion and are undergoing thoracic drainage. The trial will be conducted at multiple French centers and follows current guidelines that consider intrapleural enzyme therapy as rescue therapy. Outcomes will inform whether early irrigation can be a safer or more effective alternative.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults (≥18 years old) capable of fully understanding the study;
* Complicated pleural infection (macroscopically purulent fluid, positive for bacteria on Gram's staining, positive on culture for bacterial infection, loculated effusion, pH \<7.2, great abundance) leading to thoracic drainage;
* Initial ultrasound evaluation to estimate pleural fluid abundance and detect fibrinous septation;
* Social security affiliation
* Written informed consent
* Highly effective contraceptive methods for women of childbearing age include: Combined hormonal contraception (estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; hormone- releasing intrauterine system; bilateral occlusion of the Fallopian tubes; vasectomized partner; sexual abstinence

Exclusion Criteria:

* Tuberculous pleural effusions;
* Previous treatment with intrapleural fibrinolytic agents (urokinase, streptokinase, alteplase, or DNase) or intrapleural saline lavage;
* Previous thoracic surgery for pleural infection;
* Contraindications to auxiliary treatments, to fibrinolysis or surgery as well as to procedures such as drainage and lavage;
* Pregnancy or lactation;
* Expected survival of less than 3 months;
* Thoracic drainage since more than 24h;
* Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision);
* Inability to give informed written consent;
* Participation in another clinical trial;
* Patient being a relative of the investigator or any member of the team directly involved in the study, including assistant physicians, pharmacists, nurses, and coordinators

Where it's running

• CHU Amiens Picardie
  Amiens, Picardie, France Recruiting

Study contacts

• Study coordinator: Damien BASILLE, Pr
• Email: basille.damien@chu-amiens.fr
• Phone: 33+3 22 45 59 10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.