Comparative study for the treatment of pleural complications

Phase 1

• Conditions: Treatment of complicated parapneumatic pleural effusion or empyema; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2019-003542-32-ES
• Lead Sponsor: Dr. José Manuel Porcel Pérez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-28
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 81

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 <7.15 or glucose <40 mg/dL, 2) Gram or positive culture of pleural fluid, or 3) pleural effusion occupying 50% or more of the hemithorax on a chest x-ray or localized on an imaging test (x-ray, ultrasound, or CT).
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 81
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

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