Overview
Sponsor-declared trial summary
Pleural empyema
Is surgery up front superior to drainage in patients with pleural empyema?
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 28 Jun 2024 → ongoing
- Decision date (initial)
- 2024-06-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513596-40-00
- EudraCT number
- 2020-002484-60
- ClinicalTrials.gov
- NCT04095676
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Is surgery up front superior to drainage in patients with pleural empyema?
Conditions and MedDRA coding
Pleural empyema
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- see protocol
Exclusion criteria 1
- see protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- see protocol
Secondary endpoints 2
- see protocol
- see protocol
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB06373MIG · Substance
- Active substance
- Dornase Alfa
- Pharmaceutical form
- NEBULISER SOLUTION
- Route of administration
- INTRAPLEURAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05378MIG · Substance
- Active substance
- Alteplase
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAPLEURAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Clinical trial information desk
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Clinical trial information desk
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 184 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-06-28 | 2024-06-28 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-13 | Denmark | Acceptable 2024-06-12
|
2024-06-26 |