Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
5
Infectious S. aureus endocarditis
Key facts
- Sponsor
- Phaxiam Therapeutics
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 10 Apr 2024 → 1 Apr 2025
- Decision date (initial)
- 2023-10-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Infectious S. aureus endocarditis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10041937 | Staphylococcus aureus endocarditis | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Phaxiam Therapeutics
- Sponsor organisation
- Phaxiam Therapeutics
- Address
- Batiment Bioserra
- City
- Lyon
- Postcode
- 69008
- Country
- France
Scientific contact point
- Organisation
- Phaxiam Therapeutics
- Contact name
- Pascal Birman
Public contact point
- Organisation
- Phaxiam Therapeutics
- Contact name
- Marie Châlons Cottavoz
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Infectious and Tropical Diseases Department, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Hopital Universitaire Pitie Salpetriere
Infectious deseases, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Assistance Publique Hopitaux De Paris
Département médical et universitaire de médecin, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Centre Hospitalier Universitaire De Nantes
Explorations fonctionnelles, 1 Place Alexis Ricordeau, 44000, Nantes
CHRU De Nancy
Infectious diseases department, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
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 |
|---|---|---|---|---|---|
| France | 2024-04-10 | 2024-04-10 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-28 | France | Acceptable with conditions 2023-07-31
|
2023-08-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-06 | France | Acceptable with conditions | 2023-10-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-09 | France | Acceptable with conditions | 2024-01-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-14 | France | Acceptable 2024-04-29
|
2024-04-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-06 | France | Acceptable 2024-09-12
|
2024-09-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-04 | France | Acceptable 2024-11-07
|
2024-11-07 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-04 | France | Acceptable 2025-03-24
|
2025-03-24 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-25 | France | 2025-03-25 |