Clinical trial • Phase I • Infectious Disease
Bacteriophage for Urinary tract infection | Neurogenic bladder
Phase I trial of Bacteriophage for Urinary tract infection | Neurogenic bladder. 36 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Urinary tract infection | Neurogenic bladder
- Trial Stage
- Phase I
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 08-01-2024
- First CTIS Authorization Date
- 06-05-2024
Trial design
Phase I trial across 5 sites in France.
- Target Sample Size
- 36
- Trial Duration For Participant
- 456
Eligibility
Recruits 36 Vulnerable population selected; no details on consent or assent provided in the available record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent provided in the available record.
Recruitment
- Planned Sample Size
- 36
- Recruitment Window Months
- 15
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 36
France
- Earliest CTIS Part Ii Submission Date
- 02-04-2024
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 764
- Number Of Sites
- 5
- Number Of Participants
- 36
Sites
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Urology
- Contact Person Name
- Benoit PEYRONNET
- Contact Person Email
- benoit.peyronnet@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Infectious deseases
- Contact Person Name
- Albert SOTTO
- Contact Person Email
- albert.sotto@chu-nimes.fr
- Site Name
- Bicetre Hospital
- Department Name
- Clinical pharmacology - CRC
- Contact Person Name
- Laurent Becquemont
- Contact Person Email
- Laurent.becquemont@aphp.fr
- Site Name
- Raymond Poincare Hospital
- Department Name
- Infectious deseases
- Contact Person Name
- Aurélien DINH
- Contact Person Email
- aurelien.dinh@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Urology
- Contact Person Name
- Marie-Aimee PERROUIN VERBE
- Contact Person Email
- marieaimee.perrouinverbe@chu-nantes.fr
Sponsor
Primary sponsor
- Full Name
- Phaxiam therapeutics
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Bacteriophages (bacteriophage therapy)
- Active Substance
- Bacteriophage
- Modality
- Other
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