Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Not authorised
Participants planned
600
Countries
1
Sites
2
Chronic Rhinosinusitis associated with Staphylococcus aureus Infection
Key facts
- Sponsor
- Instytut Immunologii I Terapii Doswiadczalnej Im Ludwika Hirszfelda Pan We Wroclawiu
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Decision date (initial)
- 2025-04-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic Rhinosinusitis associated with Staphylococcus aureus Infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10080060 | Chronic rhinosinusitis with nasal polyps | 100000004855 |
| 20.0 | LLT | 10075981 | Staphylococcus aureus infection | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instytut Immunologii I Terapii Doswiadczalnej Im Ludwika Hirszfelda Pan We Wroclawiu
- Sponsor organisation
- Instytut Immunologii I Terapii Doswiadczalnej Im Ludwika Hirszfelda Pan We Wroclawiu
- Address
- Ul. Rudolfa Weigla 12
- City
- Wroclaw
- Postcode
- 53-114
- Country
- Poland
Scientific contact point
- Organisation
- Instytut Immunologii I Terapii Doswiadczalnej Im Ludwika Hirszfelda Pan We Wroclawiu
- Contact name
- Co-ordinating Investigator
Public contact point
- Organisation
- Instytut Immunologii I Terapii Doswiadczalnej Im Ludwika Hirszfelda Pan We Wroclawiu
- Contact name
- Co-ordinating Investigator
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Not authorised | 600 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Otolaryngologii, Chirurgii Głowy i Szyi Szpitala, Ul. Borowska 213, 50-556, Wroclaw
Instytut Immunologii I Terapii Doswiadczalnej Im Ludwika Hirszfelda Pan We Wroclawiu
Ośrodek Terapii Fagowej Centrum Medyczne Instytut Immunologii i Terapii Doświadczalnej, Ul. Rudolfa Weigla 12, 53-114, Wroclaw
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-31 | Poland | Not acceptable 2025-04-14
|
2025-04-22 |