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Official title Comparison of Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.
ClinicalTrials.gov ID: NCT07666464
What this study is testing
What is intrapleural irrigation?
intrapleural irrigation is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Intrapleural enzyme therapy (IET) is regarded by recent guidelines as a "rescue" therapy for managing complicated pleural infections; however, it is associated with significant side effects, including pleural bleeding, pain, and fever. Pleural irrigation with saline may serve as an alternative, yet evidence supporting its effectiveness is limited to a single small- scale, single-center randomized trial.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Initial ultrasound evaluation to estimate pleural fluid abundance and detect fibrinous septation;
- Social security affiliation
- Written informed consent
You likely can't join if
- 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;
See the full eligibility 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...
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, Picardie, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, Picardie, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.