Surgery or medicinal rinsing for infection of the chest cavity.

Phase 1

Active, not recruiting

• Conditions: Pleural Empyema; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: LLTClassification code 10037381Term: Pulmonary empyemaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2020-002484-60-DK
• Lead Sponsor: Odense Universityhospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

> 18 years or more on the day of hospitalization

Must be able to provide informed consent

Acute hospitalization within the last 48 hours

Meeting diagnostic criteria for community-induced fibropurulent stage (stage II) and the chronic organizing stage (stage III) empyema

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 164
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Pregnant

Breastfeeding

Known malignant sickness and declared terminal for this

Previous surgery (within <1 year on the same side of the thorax as where the parapneumonic effusion / pleural empyema is located

Previously (within <1 year) hospitalized with an empyema stage II-III

Drainage on the same side of the thorax (excluding diagnostic pleural puncture), including a pigtail

Use of intrapleural therapy contraindicated (e.g. allergy)

Enrollment duration at the time of diagnostic puncture > 48 hours

Hospitalization within 7 days prior to current hospitalization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if there is a difference in outcome in patients diagnosed with fibropurulent stage (stage II) and the chronic organizing stage (stage III) empyema who are receive a primary VATS surgery or ULS guided drainage and intrapleural therapy (fibrinolytic (altaplasm) with DNase (Pulmozyne ®)) <br><br> ;Secondary Objective: see protocol;Primary end point(s): Primary endpoint: <br><br> Hospitalization time, where admission time is defined as the time from first hospitalization in the course of hospitalization and to the completion of treatment (time of discharge). (In patients who cannot be discharged due to failure to receive primary care (e.g. waiting time at the relocation site), the date where the attending physician has finished the treatment is used as the discharged date). <br><br> ;Timepoint(s) of evaluation of this end point: One year follow up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): see protocol;Timepoint(s) of evaluation of this end point: one year follow up