NCT07666464

Brief Summary

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. The objective of the study is to compare the risk of treatment failure at 30 days (defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy) between an early pleural irrigation strategy and standard care for complicated pleural infections.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P50-P75 for phase_3

Timeline
36mo left

Started May 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
May 2026Aug 2029

Study Start

First participant enrolled

May 13, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 18, 2026

Last Update Submit

June 30, 2026

Conditions

TherapyPleural Infections

Keywords

therapypleural infections

Outcome Measures

Primary Outcomes (1)

  • Number of treatment failure

    Treatment failure, defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy. This criterion will be assessed at 30 days.

    at 30 days

Secondary Outcomes (11)

  • Volume of pleural fluid drained from randomization

    at day 3

  • Incidence of adverse events

    at 90 days

  • Intra-hospital mortality

    at 30 days

  • Intra-hospital mortality

    at 90 days

  • Rate of thoracic surgery

    at 30 days

  • +6 more secondary outcomes

Study Arms (2)

intrapleural irrigation

EXPERIMENTAL

Experimental group: 500 mL bags of 0.9% sodium chloride will be administered into the thoracic cavity via the chest tube using a three way tap and gravity (no infusion pump or pressure). The infusion is followed by free drainage with thoracic suction (up to -20 cmH2O). This process will occur twices daily for a total of 6 irrigations.

Drug: intrapleural irrigation

standard care

ACTIVE COMPARATOR

Control group: Standard care includes pleural drainage with 20 mL 0.9% sodium chloride flushes administered twice daily for 3 days to maintain tube patency. Thoracic suction (up to -20 cmH2O) will be applied to chest tubes.

Procedure: Standard care

Interventions

intrapleural irrigationDRUG

500 mL bags of 0.9% sodium chloride will be administered into the thoracic cavity via the chest tube using a three way tap and gravity (no infusion pump or pressure). The infusion is followed by free drainage with thoracic suction (up to -20 cmH2O). This process will occur two times daily for a total of 6 irrigations.

intrapleural irrigation
Standard carePROCEDURE

Standard care includes pleural drainage with 20 mL 0.9% sodium chloride flushes administered two times daily for 3 days to maintain tube patency. Thoracic suction (up to -20 cmH2O) will be applied to chest tubes.

standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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, 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

You may not qualify 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;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Damien BASILLE, Pr

CONTACT

33+3 22 45 59 10basille.damien@chu-amiens.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 24, 2026

Study Start

May 13, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)