Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
96
Countries
1
Sites
3
Pneumocystis pneumonia
Key facts
- Sponsor
- Centre Hospitalier Regional Universitaire De Tours
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Parasitic Diseases [C03]
- Trial duration
- 2 Dec 2025 → ongoing
- Decision date (initial)
- 2025-02-25
- 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
Pneumocystis pneumonia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073755 | Pneumocystis jirovecii pneumonia | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional Universitaire De Tours
- Sponsor organisation
- Centre Hospitalier Regional Universitaire De Tours
- Address
- 2 Boulevard Tonnelle
- City
- Tours
- Postcode
- 37000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional Universitaire De Tours
- Contact name
- Project leader
Public contact point
- Organisation
- Centre Hospitalier Regional Universitaire De Tours
- Contact name
- Project leader
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 96 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Regional D'Orleans
Intensive care, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier Regional Universitaire De Tours
Intensive care, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier Regional Universitaire De Tours
Infectious diseases, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
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 | 2025-12-02 | 2025-12-02 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-23 | France | Acceptable 2025-01-31
|
2025-02-25 |