Clinical trial • Phase I/II • Infectious Disease|Other
RhinoPHAGE-2A cocktail for Chronic rhinosinusitis|Staphylococcus aureus infection
Phase I/II trial of RhinoPHAGE-2A cocktail for Chronic rhinosinusitis|Staphylococcus aureus infection. Randomised, adaptive. 600 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease|Other
- Trial Disease
- Chronic rhinosinusitis|Staphylococcus aureus infection
- Trial Stage
- Phase I/II
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 31-12-2024
- First CTIS Authorization Date
- 22-04-2025
Trial design
Randomised, adaptive Phase I/II trial across 2 sites in Poland.
- Randomised
- Yes
- Adaptive
- True, described as a seamless, adaptive Phase I/II study; no further adaptive element details (e.g., dose escalation rules, interim analyses, stopping rules) provided in the record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 600
Eligibility
Recruits 600 No vulnerable populations selected; no consent or assent handling described in the record..
- Vulnerable Population
- No vulnerable populations selected; no consent or assent handling described in the record.
Recruitment
- Planned Sample Size
- 600
- Recruitment Window Months
- 39
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 600
Poland
- Earliest CTIS Part Ii Submission Date
- 03-04-2025
- Latest Decision Or Authorization Date
- 22-04-2025
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 600
Sites
- Site Name
- Instytut Immunologii I Terapii Doswiadczalnej Im Ludwika Hirszfelda Pan We Wroclawiu
- Department Name
- Ośrodek Terapii Fagowej Centrum Medyczne Instytut Immunologii i Terapii Doświadczalnej
- Contact Person Name
- Andrzej Górski
- Contact Person Email
- secretary@hirszfeld.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Otolaryngologii, Chirurgii Głowy i Szyi Szpitala
- Contact Person Name
- Tomasz Zatoński
- Contact Person Email
- badaniakliniczne@usk.wroc.pl
Sponsor
Primary sponsor
- Full Name
- Instytut Immunologii I Terapii Doswiadczalnej Im Ludwika Hirszfelda Pan We Wroclawiu
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- RhinoPHAGE-2A cocktail
- Modality
- Other
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