Comparative study for the treatment of pleural complications

Randomised clinical trial: saline washouts versus standard treatment in complicated parapneumonic pleural effusion or empyema. SCOPE study. - SCOPE

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003542-32-ES

Enrollment

Registered

2020-02-28

Start date

2020-02-28

Completion date

Unknown

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of complicated parapneumatic pleural effusion or empyema

Interventions

Trade Name: Pulmozyme Pharmaceutical Form: Injection INN or Proposed INN: DORNASE ALFA CAS Number: 143831-71-4 Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years of age 2. Clinical evidence of infection and purulent pleural fluid (empyema) or with one or more of the following criteria: 1) pH of pleural fluid =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Pregnant women 2. Patients allergic to the drugs used (urokinase or DNase) 3. Tuberculous pleural infection 4. Expected survival of less than 3 months for other causes 5. Major surgery on the 5 days or before or pneumectomy on the infected side 6. Stroke or major bleeding coincidence 7. Patients who do not sign the informed consent 8. Patients included in other clinical trials

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the reduction in the number of days that patients with complicated parapneumatic pleural effusion or empyema require pleural drainage; Secondary Objective: compare in all three groups: The size of the pleural effusion 3 and 6 days after intrapleural drainage placement, the need for new pleural drainage or thoracic surgery, the average stay and death or side effects. ;Primary end point(s): Reduction in the number of days patients need pleural drainage;Timepoint(s) of evaluation of this end point: Day when the pleural drain is removed	—

Measure

Time frame

Main Objective: To assess the reduction in the number of days that patients with complicated parapneumatic pleural effusion or empyema require pleural drainage; Secondary Objective: compare in all three groups: The size of the pleural effusion 3 and 6 days after intrapleural drainage placement, the need for new pleural drainage or thoracic surgery, the average stay and death or side effects. ;Primary end point(s): Reduction in the number of days patients need pleural drainage;Timepoint(s) of evaluation of this end point: Day when the pleural drain is removed

—

Secondary

Measure	Time frame
Secondary end point(s): The size of the pleural effusion 3 and 6 days after intrapleural drainage placement, the need for new pleural drainage or thoracic surgery, the average stay death or side effects. ;Timepoint(s) of evaluation of this end point: Day when the pleural drain is removed	—

Countries

Spain

Contacts

Public ContactCristina Casas

Institut de Recerca Biomèdica de Lleida (IRBLleida)

ccasas@irblleida.cat+34973705236

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026