Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
20
Countries
1
Sites
1
Patients with hip or knee infections
To study in patients with joint prosthesis infection with non-curative intent the clinical relevance of autovaccines administered through the sublingual mucosa in decreasing clinical symptoms and/or progression of infection.
Key facts
- Sponsor
- Instituto De Investigacion Marques De Valdecilla
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 17 Feb 2025 → ongoing
- Decision date (initial)
- 2025-01-23
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520226-10-00
- EudraCT number
- 2022-004192-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To study in patients with joint prosthesis infection with non-curative intent the clinical relevance of autovaccines administered through the sublingual mucosa in decreasing clinical symptoms and/or progression of infection.
Secondary objectives 4
- To compare the efficacy of autovaccines against TAS in joint prosthesis infections with non-curative treatment intention
- To evaluate patient satisfaction and tolerance to treatment with oral autovaccines.
- To compare the side effects of autovaccines versus TAS.
- To study the impact of the different non-curative surgical approaches performed (acute IPA without replacement of mobile parts, chronic IPA with partial replacement of components...) prior to adjuvant medical treatment with autovaccines versus TAS
Conditions and MedDRA coding
Patients with hip or knee infections
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients over 18 years of age
- Carriers of hip or knee prosthesis, diagnosed with an active infection
- Without the possibility of curative treatment
- Patients who sign the informed consent form
- Monomicrobial infections
Exclusion criteria 5
- Patients with the possibility of curative treatment
- Patients under 18 years of age
- Polymicrobial infections
- Fungal or mycobacterial infections
- Patients with oral corticosteroids with doses higher than 5 mg/day in the three months prior to inclusion
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical course: Presence of exudate, redness of the wound, pain, or other clinical signs of infection.
Secondary endpoints 1
- Safety assessment: local and systemic adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB20079 · Substance
- Active substance
- Sodium Chloride Solution 0.9%
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 300 U unit(s)
- Max total dose
- 300 U unit(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 9
SCP10330863 · ATC
- Active substance
- Amoxicillin Sodium
- Route of administration
- ORAL USE
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP110321403 · ATC
- Active substance
- Ambroxol Hydrochloride
- Substance synonyms
- TRANS-4-[(2-AMINO-3,5-DIBROMOBENZYL) AMINO] CYCLOHEXANOL HYDROCHLORIDE
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01AA02 — DOXYCYCLINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1004780 · ATC
- Active substance
- Clindamycin Hydrochloride
- Route of administration
- ORAL USE
- Max daily dose
- 2400 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01FF01 — CLINDAMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1166649 · ATC
- Active substance
- Bromhexine Hydrochloride
- Route of administration
- ORAL USE
- Max daily dose
- 1600 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP108791777 · ATC
- Active substance
- Metronidazole
- Route of administration
- ORAL USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- P01AB01 — METRONIDAZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12479042 · ATC
- Active substance
- Ciprofloxacin Hydrochloride
- Route of administration
- ORAL USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 750 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP109545371 · ATC
- Active substance
- Amoxicillin Sodium
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 1600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13835914 · ATC
- Active substance
- Linezolid
- Route of administration
- ORAL USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1086356 · ATC
- Active substance
- Clotrimazole
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J02AC01 — FLUCONAZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instituto De Investigacion Marques De Valdecilla
- Sponsor organisation
- Instituto De Investigacion Marques De Valdecilla
- Address
- Avenida Del Cardenal Herrera Oria S/n
- City
- Santander
- Postcode
- 39011
- Country
- Spain
Scientific contact point
- Organisation
- Instituto De Investigacion Marques De Valdecilla
- Contact name
- mar garcia
Public contact point
- Organisation
- Instituto De Investigacion Marques De Valdecilla
- Contact name
- mar garcia
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2025-02-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D_1 Protocol_2024-520226-10-00 | 1 |
| Recruitment arrangements (for publication) | Doc1 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Autovacuna | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_amoxicilina-clavulanico | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_amoxilicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_ciprofloxacino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_clindamicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_clotrimoxazol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_doxiciclina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_fluconazol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_metronidazol | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-17 | Spain | Acceptable 2025-01-23
|
2025-01-23 |