Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
100
Countries
1
Sites
3
• Recurrent respiratory infections • Recurrent urinary tract infections • Recurrent herpetic infections
Key facts
- Sponsor
- Aumed a.s.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 13 Jun 2025 → ongoing
- Decision date (initial)
- 2025-01-08
- 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
• Recurrent respiratory infections • Recurrent urinary tract infections • Recurrent herpetic infections
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10038133 | Recurrent respiratory tract infections | 10021881 |
| 20.0 | HLT | 10046577 | Urinary tract infections | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aumed a.s.
- Sponsor organisation
- Aumed a.s.
- Address
- Komoranska 326/63, Modrany Modrany
- City
- Prague
- Postcode
- 143 00
- Country
- Czechia
Scientific contact point
- Organisation
- Aumed a.s.
- Contact name
- clinical department
Public contact point
- Organisation
- Aumed a.s.
- Contact name
- clinical department
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 100 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Nemocnice Na Homolce
Oddělení Klinické biochemie, hematologie a imunologie, Roentgenova 37/2, Motol, Prague 5
Fakultni Nemocnice Ostrava
Ustav klinicke imunologie a alergologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Hradec Kralove
. Depart. Allergology and Clinical Immunology, Sokolska 581, 500 03, Novy Hradec Kralove
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 |
|---|---|---|---|---|---|
| Czechia | 2025-06-13 | 2025-06-13 | 2026-01-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-13 | Czechia | Acceptable 2024-12-12
|
2025-01-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-12 | Czechia | Acceptable 2024-12-12
|
2025-12-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-20 | Czechia | Acceptable 2026-02-17
|
2026-02-17 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-01 | Czechia | Acceptable 2026-02-17
|
2026-04-01 |